Topical Acetyl Hexapeptide-8 and the Cosmetic Appearance of Oily Skin

Study Overview
=================
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.

Official Title
-----------------
Pilot Randomized Double-Blind Controlled Trial of Topical Acetyl Hexapeptide-8 and the Cosmetic Appearance of Oily Skin

Conditions
-----------------
Oily Skin

Intervention / Treatment
-----------------
* Other: Acetyl Hexapeptide-8
* Other: Placebo vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Side of face receiving placebo vehicle<br>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. | Other: Placebo vehicle<br>* Water will be diluted to a final concentration of 10% using Cetaphil facial lotion base.<br>|
| Experimental: Side of face receiving AH8 lotion<br>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. | Other: Acetyl Hexapeptide-8<br>* Acetyl-Hexapeptide-8 peptide solution will be diluted to a final concentration of 10% using Cetaphil facial lotion base<br>* Other names: Argireline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician graded shine score |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |