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
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2015
CompletedFirst Posted
Study publicly available on registry
November 5, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedApril 5, 2017
March 1, 2017
1 month
October 31, 2015
April 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Physician graded shine score
4 weeks
Secondary Outcomes (10)
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
4 weeks
Physician graded oiliness score
2 weeks
Physician graded oiliness score
4 weeks
- +5 more secondary outcomes
Study Arms (2)
Side of face receiving placebo vehicle
PLACEBO COMPARATOROne 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
EXPERIMENTALOne 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.
Interventions
Acetyl-Hexapeptide-8 peptide solution will be diluted to a final concentration of 10% using Cetaphil facial lotion base
Water will be diluted to a final concentration of 10% using Cetaphil facial lotion base.
Eligibility Criteria
You may qualify if:
- Subjects over the age of 18
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UC Davis Department of Dermatology
Sacramento, California, 95816, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Raja Sivamani, MD, MS, CAT
University of California, Davis, Dermatology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2015
First Posted
November 5, 2015
Study Start
January 1, 2016
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
April 5, 2017
Record last verified: 2017-03