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Completed

NCT Number: NCT02597777

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Department of Dermatology

Sacramento, California, 95816, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetyl Hexapeptide-8

Other

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

Other names: Argireline

Placebo Vehicle

Other

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

Primary outcomes

  1. Physician graded shine score

    Time frame: 4 weeks

Secondary outcomes

  1. Patient satisfaction rated by each patient using the Oily Skin Self-Assessment Scale (OSSAS)

    Time frame: 2 week

  2. Patient satisfaction rated by each patient using the Oily Skin Self-Assessment Scale (OSSAS)

    Time frame: 4 week

  3. Assessment for local irritation from the topical emulsions

    Time frame: 4 weeks

    Secondary safety endpoint

  4. Physician graded oiliness score

    Time frame: 2 weeks

  5. Physician graded oiliness score

    Time frame: 4 weeks

  6. Sebum measurement

    Time frame: 2 weeks

  7. Sebum measurement

    Time frame: 4 weeks

  8. Patient satisfaction rated by each patient using the Oily Skin Impact Scale (OSIS)

    Time frame: 2 weeks

  9. Patient satisfaction rated by each patient using the Oily Skin Impact Scale (OSIS)

    Time frame: 4 weeks

  10. Physician graded shine score

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 5, 2015
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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