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

Oily Skin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02597777
• Other study ID #: 691537
• Status: Completed
• Phase: N/A
• First received: October 31, 2015
• Last updated: April 3, 2017
• Start date: January 2016
• Est. completion date: February 2016

Study information

• Verified date: March 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oily Skin

Intervention

Other:
• Acetyl Hexapeptide-8
Acetyl-Hexapeptide-8 peptide solution will be diluted to a final concentration of 10% using Cetaphil facial lotion base
• Placebo vehicle
Water will be diluted to a final concentration of 10% using Cetaphil facial lotion base.

Locations

Country	Name	City	State
United States	UC Davis Department of Dermatology	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician graded shine score		4 weeks
Secondary	Patient satisfaction rated by each patient using the Oily Skin Self-Assessment Scale (OSSAS)		2 week
Secondary	Patient satisfaction rated by each patient using the Oily Skin Self-Assessment Scale (OSSAS)		4 week
Secondary	Assessment for local irritation from the topical emulsions	Secondary safety endpoint	4 weeks
Secondary	Physician graded oiliness score		2 weeks
Secondary	Physician graded oiliness score		4 weeks
Secondary	Sebum measurement		2 weeks
Secondary	Sebum measurement		4 weeks
Secondary	Patient satisfaction rated by each patient using the Oily Skin Impact Scale (OSIS)		2 weeks
Secondary	Patient satisfaction rated by each patient using the Oily Skin Impact Scale (OSIS)		4 weeks
Secondary	Physician graded shine score		2 weeks