None listed
Conditions
Brief summary
This is a pilot study to test the skin care effects of growth factors derived from stem cells isolated from either fast tissue – CKC-E1 or from dental pulp tissue – CKC-E2. Both of these are incorporated into two CKC creams for topical human application. Benefits include reduction/removal of fine lines and wrinkles – crows’ feet and improvement in overall skin elasticity and skin hydration. CKC topical creams in the dosages under study are likely to be well tolerated; therefore, the risk/benefit appears satisfactory based on anecdotal evidence.
Interventions
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
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.
Sponsors
CK Cell Technologies Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
35 Years to 60 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed