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

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

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.

Study Overview

• Status: Completed
• Conditions: Oily Skin
• Intervention / Treatment: Other: Placebo vehicle; Other: Acetyl Hexapeptide-8

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • UC Davis Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Raja Sivamani, MD, MS, CAT, University of California, Davis, Dermatology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: October 31, 2015
• First Submitted That Met QC Criteria: November 3, 2015
• First Posted (Estimate): November 5, 2015

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 691537