Clinical trial NCT02597777: Topical Acetyl Hexapeptide-8 and the Cosmetic Appearance of Oily Skin
Official title: Pilot Randomized Double-Blind Controlled Trial of Topical Acetyl Hexapeptide-8 and the Cosmetic Appearance of Oily Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oily Skin
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Physician graded shine score
timeFrame: 4 weeks
Secondary outcomes:
measure: Patient satisfaction rated by each patient using the Oily Skin Self-Assessment Scale (OSSAS)
timeFrame: 2 week
measure: Patient satisfaction rated by each patient using the Oily Skin Self-Assessment Scale (OSSAS)
timeFrame: 4 week
measure: Assessment for local irritation from the topical emulsions
timeFrame: 4 weeks
measure: Physician graded oiliness score
timeFrame: 2 weeks
measure: Physician graded oiliness score
timeFrame: 4 weeks
measure: Sebum measurement
timeFrame: 2 weeks
measure: Sebum measurement
timeFrame: 4 weeks
measure: Patient satisfaction rated by each patient using the Oily Skin Impact Scale (OSIS)
timeFrame: 2 weeks
measure: Patient satisfaction rated by each patient using the Oily Skin Impact Scale (OSIS)
timeFrame: 4 weeks
measure: Physician graded shine score
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Department of Dermatology
state: California
Study officials:
affiliation: University of California, Davis, Dermatology
name: Raja Sivamani, MD, MS, CAT
role: PRINCIPAL_INVESTIGATOR
References: