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| Name | Class |
|---|---|
| University of Cape Town, Groote Schuur Hospital | UNKNOWN |
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The objective of this study is to determine the efficacy of seven different formulations currently marketed and commercially available cosmetic products on skin tone evenness, post-inflammatory hyperpigmentation, and discrete pigmentation in females of Fitzpatrick skin types IV-VI.
This is a single site, double-blind randomized, split face, efficacy study. All subjects will receive a cleanser, Day Cream/sunscreen, and two treatment products. The treatment products will be applied in a split face fashion including behind the ear.
Local volunteer subjects will be enrolled such that a total of eighty-four (84) subjects will complete the study; with 24 subjects completing in each treatment.
Each subject will receive a cleanser, Day Cream/sunscreen and two treatment products as per the randomization. Subjects will use the cleanser twice daily, Day Cream/sunscreen in the morning, and the treatment products as specified after cleansing in the evening, for a period of 16 weeks. Clinical assessments, non-invasive instrument measurements and photographs will be completed at baseline and weeks 4, 8, 12, and 16. Biopsies will be taken at baseline and Week 16.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cosmetic Formulations | Other | Topical emulsions containing anti-aging ingredients |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Tone Unevenness | Using a 0-9 scale where 0= even tone and 9=severe blotchy hyperpigmentation. Subjects will be recruited with mild to moderate skin tone unevenness. The goal is to show improvements by dermatologist assessments and photography | Every 4 weeks up to 16 weeks |
| Skin Firming | Using a non-invasive clinical instrument (Cutometer) skin elasticity will be measure of the facial cheek | Every 4 weeks up to 16 weeks |
| Skin Moisture | Using a non-invasive clinical instrument (SkiCon) skin conductance will be measure of the facial cheek | Every 4 weeks up to 16 weeks |
| Skin Oiliness | Using a non-invasive clinical instrument (Sebumeter) skin conductance will be measure of the facial cheek | Every 4 weeks up to 16 weeks |
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Inclusion Criteria:
Medically acceptable forms of birth control that may be used by the subject and/or his/her partner include:
Exclusion Criteria:
Self-identifying females
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Musonda Machona, MD | Contact | +27(0)634328862 | musondamachona@gmail.com | |
| Nonhlanhla P Khumalo, PhD | Contact | +27(0)214043376 | n.khumalo@uct.ac.za |
| Name | Affiliation | Role |
|---|---|---|
| Ardeshir Bayat, PhD | Professor & Co-Director, University of Cape Town | Principal Investigator |
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Single site, randomized, seven treatments, split face, efficacy study
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Products Codes A-G