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Trial registered on ANZCTR


Registration number
ACTRN12620001234909
Ethics application status
Approved
Date submitted
31/07/2020
Date registered
18/11/2020
Date last updated
18/11/2020
Date data sharing statement initially provided
18/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
To assess the effects of two cosmetic skin creams containing stem cell-derived growth factors developed by CK Cell Technologies Pty Ltd.
Scientific title
A randomised, placebo-controlled pilot double blind study to assess the safety, tolerability and efficacy of two CKC cosmetic creams containing Mesenchymal Stem Cell-derived growth factors and cytokines when applied topically to healthy female volunteers.
Secondary ID [1] 301927 0
None
Universal Trial Number (UTN)
U1111-1256-3150
Trial acronym
AAST-MSC-CM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Facial skin 318444 0
Condition category
Condition code
Skin 316857 316857 0 0
Normal skin development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We have two products - CKC E1 and CKC E2.
CKC-E1: Contains CKC Adipose mesenchymal stem cell secretion-derived growth factors and cytokines.
CKC-E2: Contains CKC Dental mesenchymal stem cell secretion-derived growth factors and cytokines.
These stem cell secretions have great cosmetic potential and form the basis of our facial cream.
In this randomised, placebo controlled split face double blind study, 24 healthy female volunteers, aged between 35-60 years (inclusive) will be recruited. Prior to undergoing study procedures, the participants will be required to sign an informed consent form. Following this, participants will be assessed to determine their eligibility.
Qualified participants will be randomised in a 1:1 ratio to one of the two following cohorts:
Cohort 1 (n=12) – CKC-E1 or placebo to be applied twice daily on each side of the face (right
or left at random) for 8 weeks.
Cohort 2 (n=12) – CKC-E2 or placebo to be applied twice daily on each side of the face (right
or left at random) for 8 weeks.
Participants will self-apply the investigational products to half face only twice daily (morning and evening) after cleansing the skin, for 8 weeks. This includes applying the assigned investigational product twice daily (morning and evening) for 8 weeks on one side of the face and a placebo cream (which does not contain the stem cell derived growth factors and cytokines) on the other side, which serves as control. Participants should wash their hands between applications to avoid contamination between the two products. Participants will be blinded to which is the investigational product or placebo.
Participants will be instructed as follows:
1. Store the creams at room temperature. Excessive temperatures (over 35°C) to be avoided.
2. Cleanse skin as usual with water or your standard cleanser.
3. Imagining a line from the top of the forehead down to the chin through the middle of the nose, apply one cream (approximately half fingertip or small pea size) on the right side of the face and massage gently until completely absorbed
4. Wash hands.
5. Apply other cream (approximately half fingertip or small pea size) on the left side of the face and massage gently until completely absorbed
6. Wash hands
7. Follow with sun protection (daytime only) and/or makeup as needed
8. Repeat morning and night

On visit days, participants must not apply investigational products after cleansing the skin. Last product application should be the night before the next visit.

Skin hydration and elasticity assessments will be conducted at Baseline (Day 0) and at Week 4 and 8. Skin roughness and skin visual properties assessments will be conducted at Baseline (Day 0) and Week 8. The main portion of the study, i.e cream application will be at each patient's own location.
Skin assessments will be conducted at an AGPAL Accredited clinic by a GP with at least 30 years of experience, in an appropriately temperature and humidity-controlled room. It is anticipated that approximately 20 minutes are required for skin to equilibrate to the required temperature. This will provide standardised conditions for all participants being assessed.
Hydration and elasticity measurements will be taken on zygomatic bone area; while skin replica for the purpose of image analysis, will be taken on the left and right outer corner of the eye (crow’s feet). Visual skin properties will be based on front and side facial images taken at Baseline and Week 8 only.
Through this study, we expect to contribute greatly to the development of cosmetic products in skin care.
Intervention code [1] 318210 0
Treatment: Other
Comparator / control treatment
Placebo group treatments include the base cream without CKC-E1 or CKC-E2, meaning absence of mesenchymal stem cell-derived cytokines and growth factors.
Base Cream Composition:
Water, Caprylic/Capric Triglyceride, Glycerine, Cetearyl Olivate, Dimethyl Isosorbide, Jojoba Oil, Cetearyl Alcohol, Polyacrylamide, Natural Vitamin E, C13- 14 Isoparaffin , Phenoxyethanol, Avocado Oil, Macadamia Oil, Camellia Oil, Stearic Acid, Carbomer, Lavender Australian Oil, Sandalwood Nut Australian Virgin Oil, Ethylhexylglycerin, Laureth-7, Kakadu Plum Extract, Lilly Pilly Fruit Extract, Quandong Fruit Extract, Aloe Vera Extract 200:1, Neroli Oil, Lemon Myrtle Oil, Sodium Hydroxide
Control group
Placebo

Outcomes
Primary outcome [1] 324603 0
To ascertain the effects of two different CKC creams on skin hydration taken on zygomatic bone area as per assessments recorded at time points listed below.

On each scheduled assessment day (± 3 days), participants will arrive in time for skin temperature equilibration (~20 minutes) in an appropriately temperature and humidity-controlled room at the facility.
The following parameters will be measured:
Skin Hydration by Corneometer® CM 825 ((Courage + Khazaka electronic GmbH)
The study will utilize standardized equipment for objective measurements. Each primary efficacy measure will be evaluated at two sites: left and right sides of the face (zygomatic bone area).
The Corneometer® CM 825 determines the hydration level of the skin surface (stratum corneum). The measurement is based on capacitance measurement of a dielectric medium, here the stratum corneum, the uppermost layer of the skin. With increasing hydration, its di-electric properties change. The measurement principle is based on the fact that water has a higher dielectric constant (81) than most other substances (mainly < 7). The Corneometer® CM 825 measures the change in the dielectric constant due to skin surface hydration changing the capacitance of a precision capacitor.

Timepoint [1] 324603 0
Day 0 (baseline, before cream application) as compared to Week 4 - 4 weeks post first cream application and Week 8 - 8 weeks post first cream application, (which is also the primary time point) are the time points for this assessment.
Primary outcome [2] 324604 0
To ascertain the effects of two different CKC anti-ageing creams on skin elasticity taken on zygomatic bone area as per assessments taken at time points listed below.
On each scheduled assessment day (± 3 days), participants will arrive in time for skin temperature equilibration (~20 minutes) in an appropriately temperature and humidity-controlled room at the facility.
The following parameters will be measured:

Skin Elasticity by Cutometer® Dual MPA 580 (Courage + Khazaka electronic GmbH)
The Cutometer® Dual MPA 580 (Courage + Khazaka electronic GmbH) is a standard method to measure elasticity based on suction. Negative pressure created by a vacuum pump within the device draws the skin into the aperture of the probe. Inside the probe, the penetration depth is determined by a non-contact optical measuring system consisting of a light source and a light receptor as well as two prisms facing each other which project the light from transmitter to receptor. The light intensity varies due to the penetration depth of the skin.
Timepoint [2] 324604 0
Day 0 (baseline, before cream application) compared to Week 4 - 4 weeks post first cream application and Week 8 - 8 weeks post first cream application, (which is also the primary time point) are the time points for this assessment.
Primary outcome [3] 324605 0
To ascertain the effects of two different CKC anti-ageing creams on skin roughness by image analysis of skin replica on the left and right outer corner of the eye (crow's feet) as per assessments taken at time points listed below.
On each scheduled assessment day (± 3 days), participants will arrive in time for skin temperature equilibration (~20 minutes) in an appropriately temperature and humidity-controlled room at the facility.
The following parameters will be measured:
Skin texture by Image Analysis of digital photos (except Week 4)
Image Pro Premium is an image analysis software used to objectively analyse the deeper lines and macro wrinkles such as crow’s feet. The measurement is based on digital photos of the left and right outer corner of the eye (crow’s feet) which serve as a basis for different arithmetical calculations (length, depth and area of the wrinkles). Skin properties to be evaluated include texture and wrinkle analysis by image analysis of digital photos of the left and right outer corner of the eye (crow’s feet).
Timepoint [3] 324605 0
Day 0 (baseline, before cream application) compared to Week 8 - 8 weeks post first cream application, (which is also the primary time point) are the time points for this assessment.
Secondary outcome [1] 385151 0
Primary Outcome 4:
To ascertain the effects of two different CKC creams on visual skin properties based on front and side facial images at time points as listed below.
On each scheduled assessment day (± 3 days), participants will arrive in time for skin temperature equilibration (~20 minutes) in an appropriately temperature and humidity-controlled room at the facility.
The following parameters will be measured:
Skin visual properties (like skin-texture etc) by digital photographs (except Week 4)
Front and side facial photographs of each participant will be taken in a dedicated photography room under standardised conditions. The custom-made digital photography equipment, which includes a Canon EOS 60D DSLR camera and facial positioning device, will allow high resolution full facial photos to be taken maintaining constant lighting, positioning and exposure for easy comparison.
Timepoint [1] 385151 0
Day 0 (baseline, before cream application) compared to Week 8 - 8 weeks post first cream application, (which is also the primary time point) are the time points for this assessment.
Secondary outcome [2] 385153 0
Secondary outcome 1:
Safety assessment of the cream(s)
Participants at their location will themselves record the incidence and severity of any adverse events that occur during the study, and that are related to the products in question i.e cream containing CKC-E1 and CKC-E2 when applied to left and right sides of the face. Adverse events will be assessed by the PI and recorded in the Case Report Form.
Adverse events will be captured from time of first dose of investigational product. Participants will be queried at in-clinic visits about the occurrence of adverse events using non-leading questions such as, “Have you had any changes in your health since your last study visit?”
For instance, at each visit the Investigator will score each side of the face for any signs of irritation according to the following scale:
Erythema
0.0 = No response.
0.5 = Minimal erythema.
1.0 = Erythema.
2.0 = Erythema, induration.
4.0 = Erythema + induration + vesicles.
4.0 = Severe reaction with erythema, induration, vesicles (may be weeping), pustules.
At times designated on the Schedule of Time and Events, participants will complete questionnaires assessing tolerability towards the creams and any adverse events recorded thereafter.

Yes, skin irritation is considered an adverse event. Each participant is subjected to 24 hour patch test with the product before undergoing full treatment and if skin irritation is observed, the participant will be excluded. Other examples of Adverse events include skin rashes, redness, swelling etc which are related directly to the application of the cream.

Adverse events will be tabulated, including categorical information of interest such as onset and resolution times, time of onset relative to dose, severity at onset, maximum severity, causal relationship to investigational product, and action will be taken accordingly.
Treatment-emergent adverse events (TEAEs) are defined as any AE that started after the first dose of investigational product or started prior to the first dose but increased in severity or frequency after dosing. The incidence of TEAEs will be presented by system organ class and preferred term. Adverse events will also be summarized by severity and relationship to the IP. The incidence of AEs leading to withdrawal from the study will be presented.
Listings of any serious adverse events (SAEs), deaths, and AEs or abnormal laboratory values leading to discontinuation of a participant from the study will be presented.
Timepoint [2] 385153 0
This assessment will be recorded daily in a diary for 8 weeks post the first cream application, where daily application of the investigational creams containing CKC-E1 and CKC-E2 will be monitored for compliance assessment, any concomitant medication taken and any adverse events experienced thereafter.
Secondary outcome [3] 386381 0
Tolerability assessment of the creams
Participants at their location will themselves record the incidence and severity of any skin irritation (or any other such adverse event) that occur during the study, and that are related to the products in question i.e cream containing CKC-E1 and CKC-E2 when applied to left and right sides of the face. Tolerability score for the two CKC creams based on the erythema severity scale (as listed above in Secondary outcome 1) will be tabulated and details leading to discontinuation of a participant from the study will be presented.
Timepoint [3] 386381 0
This assessment will be recorded daily for 8 weeks post the first cream application in a diary, where daily application of the investigational creams containing CKC-E1 and CKC-E2 will be monitored for compliance assessment, any concomitant medication taken and any adverse events experienced thereafter.
Secondary outcome [4] 386428 0
Participants’ self-assessment questionnaire on the products’ sensory aspects
Participants will complete questionnaires about the investigational creams, based on their 'skin-feel' evaluation, that includes parameters like a strong, satisfying and pleasant sensory stimulation. The parameters for judgement also include but are not limited to product appearance, rub-in, absorption, appearance of skin (shine), immediate and delayed after-feel, and other attributes like oiliness/greasiness and feeling of being moisturized as a composite secondary outcome.
The questionnaire is a self-designed one, specifically designed for the purpose of this study and is based upon evaluating the characteristics of the cream.

Timepoint [4] 386428 0
Assessment will be done at Day 0 (Baseline), Week 4 - 4 weeks post first cream application and Week 8 - 8 weeks post first cream application, are the time points for this assessment.
Secondary outcome [5] 386429 0
Participants’ self-assessment questionnaire on the products’ efficacy
Participants will complete questionnaires about the investigational creams that ensures a highly satisfying functionality capable of providing apparent results since the very first application. These self-reported outcomes will be based on left and right side facial application.
The questionnaire is a self-designed one, specifically designed for the purpose of this study and is based upon evaluating the characteristics of the cream.
Timepoint [5] 386429 0
Assessment will be done at Day 0 (Baseline), Week 4 - 4 weeks post first cream application and Week 8 - 8 weeks post first cream application, are the time points for this assessment.
Secondary outcome [6] 386430 0
Participants who have provided consent will also complete an optional marketing survey as per requirement by the schedule of events, at the clinic location.
1. This is a marketing survey designed specifically for this study.
2. The marketing survey is optional and will ask participants about their experience with using the interventional product(s) in terms of their secondary outcomes as listed below..
Timepoint [6] 386430 0
Final Visit post Week 8 (Final visit will be any time after 8 weeks post commencement of the cream trial)
Secondary outcome [7] 388746 0
Efficacy of the skin cream - This secondary outcome will be assessed using a study-specific marketing survey.
Timepoint [7] 388746 0
Assessment will be done at 8 weeks post first cream application
Secondary outcome [8] 388747 0
Feasibility of the skin cream - This secondary outcome will be assessed using a study-specific marketing survey.
Timepoint [8] 388747 0
Assessment will be done at 8 weeks post first cream application
Secondary outcome [9] 388748 0
Acceptability of the skin cream - This secondary outcome will be assessed using a study-specific marketing survey.
Timepoint [9] 388748 0
Assessment will be done at 8 weeks post first cream application

Eligibility
Key inclusion criteria
Participants must meet all of the following criteria to be considered eligible to participate in the study:
1. Healthy adult females aged 35-60 years (inclusive).
2. Signs of skin ageing on the face such as loss of skin tone, dehydration, lines and wrinkles, uneven skin colour.
3. Willingness to avoid extensive sun exposure, phototherapy, or use of a tanning salon for the duration of the study.
4. Willingness and ability to comply with all scheduled study visits, contraception requirements and other study procedures.
5. Willingness to avoid using any other anti-ageing facial products for the period of the study.
6. Willingness to continue their normal skin care products, if applicable, and not to introduce new skin care products/regimens 2 weeks before the start and during the study.
7. Willingness to come to each visit without any facial creams, sunscreen, makeup since the night before the visit.
8. Good general health as determined by the Principal Investigator.
9. Participant must have read and understood informed consent form and signed prior to any study-related assessments being performed.
10. Deemed able to read and understand English in order to communicate with research staff and complete protocol procedures, including the required questionnaires and forms.
Minimum age
35 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
participant will be excluded from the study if any of the following criteria apply:
1. Mental illness which, in the opinion of the Investigator, may affect their ability to provide informed consent or to participate and complete the study per protocol.
2. Women who are pregnant, lactating, or have a positive or indeterminate pregnancy result at the Screening or Week 4 visit.
3. Women of childbearing potential who are sexually active, and who are not willing to use an acceptable method of birth control) as per section 9.4.4 of the protocol) during the study period and for 30 days after end of study treatment.
4. History of or current allergy to any of the investigational products ingredients.
5. Personal history of skin cancer or any other skin conditions which are deemed by the Investigator to constitute a risk or contraindication for participation in the study that could interfere with the study objectives, conduct or evaluation.
6. Use of any topical preparation containing stem cell-derived growth factors or cytokines within 1 month of prior to enrolment.
7. Unwilling to refrain from smoking for the period of the study and has a history of smoking within the last 6 months.
8. Hormonal replacement therapy in the past within two years of screening.
9. Extreme sun exposures two months prior to study entry.
10. Anti-ageing interventions including microsurgery, dermabrasion and retinoids in the past 5 years.
11. Inappropriate for measurement in the designated skin area, per the Investigator’s judgment.
12. Skin diseases or skin therapy in the facial area.
13. Significant history of illicit drug or alcohol use or abuse, in the opinion of the Investigator.
14. Significant systemic allergies, in the opinion of the investigator, or hypersensitivity to cosmetics and drugs.
15. Currently taking any medications which are not at a stable dose and deemed by the investigator to potentially alter the properties of the skin.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is an double blind study. Neither the study staff nor the participant will know the treatment assignment. The study blind may be broken only if the safety of a participant is at risk and the treatment plan for that participant depends on which study product she received. If unblinding is required, the study personnel may access the identity of the administered study dose by opening the sealed envelope corresponding to the participant’s randomisation number. The sealed randomisation envelopes should be stored in a locked area with controlled access until required to break the blind in the event of an emergent condition in a treated participant. Unless the participant is at immediate risk, the Investigator must make diligent attempts to contact the sponsor before unblinding the participant’s data. If a participant’s data are unblinded without the prior knowledge of the Sponsor, the Investigator must notify the Sponsor as soon as possible and no later than the next business morning. All circumstances surrounding a premature unblinding must be clearly documented.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation code will be utilised to assign participants to each cohort and to apply the investigational products to the right or left side of the face.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
STATISTICAL METHODS
1) SAMPLE SIZE DETERMINATION
As the study is exploratory in nature, no formal statistical calculations have been performed.
2) DEFINITION OF ANALYSIS POPULATIONS
Two analysis populations are defined as follows:
• Safety population: all participants who are treated with investigational product. The safety population is the population used for all safety analyses, and participants are analysed “as treated”.
• Full Analysis Set (FAS): all participants who are successfully screened and randomised and receive at least 1 dose of investigational product, and provide at least 1 set of post-baseline pain assessments. The FAS population is the primary population for the efficacy analysis. Membership in the FAS population will be confirmed with blinded review, and participants are analysed “as randomised”.
• Per-Protocol (PP) population: participants in the FAS who have completed the study and have no significant protocol deviations that would affect interpretation of their efficacy data. The PP population is the supportive population for the efficacy analysis. Membership in the PP population will be confirmed with blinded review, and participants are analysed “as randomised”.
3) STATISTICAL ANALYSES
Descriptive summaries of safety and efficacy variables will be provided where appropriate. For continuous variables, the number of observations (n), the mean, standard deviation, median, minimum, and maximum will be tabulated by treatment groups. For categorical variables, the counts and percentages (where percentages are appropriate) of each value will be tabulated by treatment groups.
4) BASELINE CHARACTERISTICS
Participant characteristics (e.g., sex, body weight, race and ethnicity) will be summarised descriptively. Demographic data will be summarized and tabulated. Continuous variables will be summarized using number of observations (n), mean, standard deviation (SD), coefficient of variation (CV [%]), median, minimum, and maximum. Frequencies and percentages will be reported for all categorical data.
5) INSTRUMENTAL MEASUREMENT AND SKIN REPLICA ANALYSIS
To analyse the skin replicas, digital photographs will be taken in a light-proof room. The only source of illumination will be an LED lamp positioned perpendicular to the main wrinkle lines, illuminating them from a shallow angle. In doing so, shadows are projected relative to a wrinkle’s area, length, and depth. The camera will be fixed to a tripod, pointing directly downward in order to face the replica in a perpendicular manner. The replica will be held in place using four small protrusions to ensure consistency in position between photographs. Each image will be processed in GIMP - cropping, conversion to greyscale, normalisation and image size reduction operations were performed in order to facilitate image analysis.
After images are processed in this fashion, they will be imported into Image Pro Premier (IPP) for image analysis. The specified analysis area will be restricted to a 2.5cm diameter circle in the middle of each replica. Any areas of the image with a brightness value of 100 units or less will be selected, with adjacent pixels defining a single object. Each object for each replica will be measured in several different dimensions, including object area and length. The analysis area will then be measured for roughness (heterogeneity) and number of shadow objects present.
Both instrumental measures and replica data will be transferred to SAS for analysis. Descriptive statistics will be calculated and averaged over participants for each measure and visit. These averages will be analysed inferentially using repeated measures analysis of covariance within a mixed models framework. Inferential statistical analysis will be performed in order to assess if each parameter (the dependent measure) varies linearly over time. The Baseline value (Visit 1) of the measure, in addition to age, skin phototype and skin sensitivity will be used as covariates within each measure.
Adjusted means, calculated as Least Squared Means in the analyses, will be presented in the tables with probabilities less than 0.05 indicating significant differences between selected means. The adjusted means between the first and last visit will be compared using a t-test to see if there was an overall change at the end of the study. The final timepoint of each group will also be compared in a similar manner. Output for adjusted mean change will be presented in figures as the difference between the first and final visits. All graphs will show adjusted mean values with standard error bars for each area and time point, based on the results of the mixed models analysis. Least Square Means will be reported as adjusted means in the tables.
Change from Baseline will be calculated and descriptive statistics will also be calculated for each measure. This includes number of observations (n), mean, percentage change, standard deviation (SD), minimum, median and maximum values for each parameter’s value and its change from Baseline.
6) SAFETY AND TOLERABILITY
A. ADVERSE EVENTS
Adverse events will be tabulated, including categorical information of interest such as onset and resolution times, time of onset relative to dose, severity at onset, maximum severity, causal relationship to investigational product, and action taken.
Treatment-emergent adverse events (TEAEs) are defined as any AE that started after the first dose of investigational product or started prior to the first dose but increased in severity or frequency after dosing. The incidence of TEAEs will be presented by system organ class and preferred term. Adverse events will also be summarized by severity and relationship to the IP. The incidence of AEs leading to withdrawal from the study will be presented. Listings of any serious adverse events (SAEs), deaths, and AEs or abnormal laboratory values leading to discontinuation of a participant from the study will be presented.
B. VITAL SIGNS
Individual vital sign measurements (SBP, DBP, and HR) will be listed by measurement time and summarized using descriptive statistics.
C. SKIN EXAMINATION
Skin examination will be summarized. Any clinically significant change from baseline in the skin examination may be recorded as an AE if deemed appropriate by the PI or Sponsor.
D. CONCOMITANT MEDICATIONS
Prior and concomitant medications will be identified using the most current version of the World Health Organization (WHO) Drug dictionary. The incidence of prior and concomitant medication use will be summarized.
E. PARTICIPANT QUESTIONNAIRE
Participant questionnaire data will be summarized by timepoint(s).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/12/2020
Actual
Date of last participant enrolment
Anticipated
22/12/2020
Actual
Date of last data collection
Anticipated
28/01/2021
Actual
Sample size
Target
23
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17181 0
Oztrials Clinical Research - Drummoyne
Recruitment postcode(s) [1] 30881 0
2047 - Drummoyne

Funding & Sponsors
Funding source category [1] 306340 0
Commercial sector/Industry
Name [1] 306340 0
CK Cell Technologies Pty Ltd
Country [1] 306340 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
CK Cell Technologies Pty Ltd
Address
CK Cell Technologies Pty Ltd
Unit 31, 11-13 Brookhollow Avenue
Norwest, NSW 2153
Australia
Country
Australia
Secondary sponsor category [1] 306845 0
None
Name [1] 306845 0
Address [1] 306845 0
Country [1] 306845 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306549 0
Bellberry Limited - Supporting research and ethics
Ethics committee address [1] 306549 0
Ethics committee country [1] 306549 0
Australia
Date submitted for ethics approval [1] 306549 0
05/11/2019
Approval date [1] 306549 0
10/09/2020
Ethics approval number [1] 306549 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104254 0
Dr Joanne Grimsdale
Address 104254 0
Oztrials Clinical Research
Suite 1, 56-56A Thompson Street
Drummoyne NSW 2047
Country 104254 0
Australia
Phone 104254 0
+61 2 9181 2328
Fax 104254 0
Email 104254 0
[email protected]
Contact person for public queries
Name 104255 0
Kuldip Sidhu
Address 104255 0
CK Cell Technologies Pty Ltd.
Unit 31, 11-13 Brookhollow Avenue
Baulkham Hills, NSW 2153
Australia
Country 104255 0
Australia
Phone 104255 0
+61 401766055
Fax 104255 0
Email 104255 0
[email protected]
Contact person for scientific queries
Name 104256 0
Kuldip Sidhu
Address 104256 0
CK Cell Technologies Pty Ltd.
Unit 31, 11-13 Brookhollow Avenue
Norwest, NSW 2153
Australia
Country 104256 0
Australia
Phone 104256 0
+61 401766055
Fax 104256 0
Email 104256 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8659Study protocol  [email protected]
8660Statistical analysis plan  [email protected]
8661Informed consent form  [email protected]
8662Ethical approval  [email protected]



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