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

NCT ID: NCT02597777

Last Updated: 2017-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-02-29

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.

Conditions

Oily Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo vehicle

Intervention Type: OTHER

Water will be diluted to a final concentration of 10% using Cetaphil facial lotion base.

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.

Group Type: EXPERIMENTAL

Acetyl Hexapeptide-8

Intervention Type: OTHER

Acetyl-Hexapeptide-8 peptide solution will be diluted to a final concentration of 10% using Cetaphil facial lotion base

Interventions

Acetyl Hexapeptide-8

Acetyl-Hexapeptide-8 peptide solution will be diluted to a final concentration of 10% using Cetaphil facial lotion base

Intervention Type: OTHER

Placebo vehicle

Water will be diluted to a final concentration of 10% using Cetaphil facial lotion base.

Intervention Type: OTHER

Other Intervention Names

Argireline

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raja Sivamani, MD, MS, CAT

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis, Dermatology

Locations

UC Davis Department of Dermatology

Sacramento, California, United States

Countries

United States

Other Identifiers

691537

Identifier Type: -

Identifier Source: org_study_id