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

Not Applicable

Completed

• Conditions: Oily Skin
• Interventions: Other: Placebo vehicle; Other: Acetyl Hexapeptide-8

• Registration Number: NCT02597777
• Lead Sponsor: University of California, Davis

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-10-31
• Study First Submitted QC: 2015-11-03
• Study First Posted: 2015-11-05
• Study Start: 2016-01
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Subjects over the age of 18

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Side of face receiving placebo vehicle	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.
Side of face receiving AH8 lotion	Acetyl Hexapeptide-8	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.

Primary Outcome Measures

Name	Time	Method
Physician graded shine score	4 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UC Davis Department of Dermatology; 🇺🇸 Sacramento, California, United States