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This is a randomized double-blinded study examining the effect of topical Acetyl Hexapeptide-8 AH8) for improving the cosmetic appearance and experience of oily skin.
The purpose of this randomized double-blinded study is to investigate whether topical Acetyl Hexapeptide-8 can improve oily skin. Up to 15 adult subjects will be recruited. Each half of the face will randomized to receive either topical treatment with AH8 10% Lotion formulated in Cetaphil® Moisturizing Facial Lotion or the placebo vehicle treatment consisting of Cetaphil® Moisturizing Facial Lotion only, at twice daily application for 4 weeks.
The study consists of a total of 3 sessions: baseline visit, and at 2 weeks and 4 weeks for follow up assessment. Subjects will also be asked to complete an Oily Skin Self-Assessment Scale (OSSAS) and an Oily Skin Impact Scale (OSIS) survey at the first session. They will be filling out two OSSAS surveys (one for each side of the face) at the second and third sessions. The OSSAS survey includes subjective assessment of four components of oily skin: visual, blotting, tactile, and sensation. At each visit, the cosmetic appearance the facial skin will be scored clinically by a dermatologist using a validated 3-point scale for shine (1 = high, 2, moderate or 3 = low), and oiliness (1 = normal, 2 = easily visible or 3 = extensive) 16. High-resolution digital photographs of the facial skin with the use of photography and facial analysis instrumentation will be taken at baseline and at each visit to document facial appearance and for image analysis of shine level. Sebum of the left and right cheeks will be measured by a sebumeter to correlate to the oily appearance noted on the high resolution facial photographs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Side of face receiving placebo vehicle | Placebo Comparator | One half of the face (left or right side) will be randomized to receive the placebo lotion. Subjects will be asked to apply a pea-sized amount of the lotion to half of the face at twice daily application for 4 weeks. |
|
| Side of face receiving AH8 lotion | Experimental | One half of the face (left or right side) will be randomized to receive the 10% Acetyl Hexapeptide-8 containing (AH8) lotion. Subjects will be asked to apply a pea-size amount of the lotion to the half of the face twice daily application for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetyl Hexapeptide-8 | Other | Acetyl-Hexapeptide-8 peptide solution will be diluted to a final concentration of 10% using Cetaphil facial lotion base |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physician graded shine score | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction rated by each patient using the Oily Skin Self-Assessment Scale (OSSAS) | 2 week | |
| Patient satisfaction rated by each patient using the Oily Skin Self-Assessment Scale (OSSAS) | 4 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raja Sivamani, MD, MS, CAT | University of California, Davis, Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Department of Dermatology | Sacramento | California | 95816 | United States |
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| ID | Term |
|---|---|
| C582852 | acetyl-glutamyl-glutamyl-methionyl-glutaminyl-arginyl-argininamide |
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| Placebo vehicle | Other | Water will be diluted to a final concentration of 10% using Cetaphil facial lotion base. |
|
| Assessment for local irritation from the topical emulsions | Secondary safety endpoint | 4 weeks |
| Physician graded oiliness score | 2 weeks |
| Physician graded oiliness score | 4 weeks |
| Sebum measurement | 2 weeks |
| Sebum measurement | 4 weeks |
| Patient satisfaction rated by each patient using the Oily Skin Impact Scale (OSIS) | 2 weeks |
| Patient satisfaction rated by each patient using the Oily Skin Impact Scale (OSIS) | 4 weeks |
| Physician graded shine score | 2 weeks |