Oily Skin
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERAcetyl Hexapeptide-8
Acetyl-Hexapeptide-8 peptide solution will be diluted to a final concentration of 10% using Cetaphil facial lotion base
OTHERPlacebo vehicle
Water will be diluted to a final concentration of 10% using Cetaphil facial lotion base.
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects over the age of 18
Exclusion criteria
* Recent intradermal botulinum neurotoxin injection within the last 6 months. * Known hypersensitivity to AH8 * Ablative resurfacing procedures to the face within 6 months of the study initiation * Report of pregnancy or breastfeeding * Use of immunosuppressive drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physician graded shine score | 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction rated by each patient using the Oily Skin Impact Scale (OSIS) | 2 weeks | — |
| Physician graded shine score | 2 weeks | — |
| Sebum measurement | 2 weeks | — |
| Assessment for local irritation from the topical emulsions | 4 weeks | Secondary safety endpoint |
| Physician graded oiliness score | 2 weeks | — |
| Patient satisfaction rated by each patient using the Oily Skin Self-Assessment Scale (OSSAS) | 2 week | — |
Countries
United States
Outcome results
None listed