Oily SkinNCT02597777
Topical Acetyl Hexapeptide-8 and the Cosmetic Appearance of Oily Skin
A study testing Acetyl Hexapeptide-8 in people with Oily Skin, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oily Skin
- What is being tested?
- Acetyl Hexapeptide-8
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects over the age of 18
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Department of Dermatology
Sacramento, California, 95816
About this study
Official title: Pilot Randomized Double-Blind Controlled Trial of 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.
Read the 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.
- Conditions
- Oily Skin
- Being tested
- Acetyl Hexapeptide-8, Placebo vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetyl Hexapeptide-8Other
Also called Argireline
Acetyl-Hexapeptide-8 peptide solution will be diluted to a final concentration of 10% using Cetaphil facial lotion base
Placebo vehicleOther
Water will be diluted to a final concentration of 10% using Cetaphil facial lotion base.
| Study group | Role | What they receive |
|---|---|---|
| Side of face receiving placebo vehicle | Placebo comparator | 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. Receives: Other: Placebo vehicle |
| Side of face receiving AH8 lotion | Experimental | 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. Receives: Other: Acetyl Hexapeptide-8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician graded shine score
Measured: 4 weeks
Secondary outcomes (10)
Patient satisfaction rated by each patient using the Oily Skin Self-Assessment Scale (OSSAS)
Measured: 2 week
Patient satisfaction rated by each patient using the Oily Skin Self-Assessment Scale (OSSAS)
Measured: 4 week
Assessment for local irritation from the topical emulsions
Secondary safety endpoint
Measured: 4 weeks
Physician graded oiliness score
Measured: 2 weeks
Physician graded oiliness score
Measured: 4 weeks
Sebum measurement
Measured: 2 weeks
Sebum measurement
Measured: 4 weeks
Patient satisfaction rated by each patient using the Oily Skin Impact Scale (OSIS)
Measured: 2 weeks
Patient satisfaction rated by each patient using the Oily Skin Impact Scale (OSIS)
Measured: 4 weeks
Physician graded shine score
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oily SkinStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raja Sivamani, MD, MS, CAT, Principal investigator, University of California, Davis, Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597777
- Sponsor's protocol ID
- 691537
- Status last verified
- Mar 2017
- First submitted
- 31 Oct 2015
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Double-Blind Controlled Trial of Topical Acetyl Hexapeptide-8 and the Cosmetic Appearance of Oily Skin
- ClinicalTrials.gov ID
- NCT02597777
- Acronym / sponsor ID
- 691537
- Conditions
- Oily Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Side of face receiving placebo vehicle | Placebo comparator | Other: Placebo vehicleOne 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 | Experimental | Other: Acetyl Hexapeptide-8One 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects over the age of 18
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetyl Hexapeptide-8Also: ArgirelineAcetyl-Hexapeptide-8 peptide solution will be diluted to a final concentration of 10% using Cetaphil facial lotion base | Other | Side of face receiving AH8 lotion |
| Placebo vehicleWater will be diluted to a final concentration of 10% using Cetaphil facial lotion base. | Other | Side of face receiving placebo vehicle |
Primary outcome
Physician graded shine score
Time frame: 4 weeks
10 secondary outcomes
Patient satisfaction rated by each patient using the Oily Skin Self-Assessment Scale (OSSAS)
Time frame: 2 week
Patient satisfaction rated by each patient using the Oily Skin Self-Assessment Scale (OSSAS)
Time frame: 4 week
Assessment for local irritation from the topical emulsions
Time frame: 4 weeks
Physician graded oiliness score
Time frame: 2 weeks
Physician graded oiliness score
Time frame: 4 weeks
Sebum measurement
Time frame: 2 weeks
Sebum measurement
Time frame: 4 weeks
Patient satisfaction rated by each patient using the Oily Skin Impact Scale (OSIS)
Time frame: 2 weeks
Patient satisfaction rated by each patient using the Oily Skin Impact Scale (OSIS)
Time frame: 4 weeks
Physician graded shine score
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
Related trials for Oily Skin
RecruitingPhase 2
FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)
Dermatomyositis (DM), Juvenile Dermatomyositis (JDM)
Recruiting
Dermal and Ophthalmological Acceptability and Comedogenicity Assessment of a Cosmetic Product
Oily Skin, Acne Prone Skin
RecruitingPhase 4
Prospective Evaluation of Topical Almond Oil vs Hydroquinone
Skin Pigmentation
RecruitingEarly Phase 1
Tart Cherry and Omega-3's for Aromatase Inhibitor Musculoskeletal Symptoms
Breast Cancer, Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)
Active, not recruitingPhase 1
Fish Oil Supplementation During Pregnancy for Prevention of Asthma, Eczema and Allergies in Childhood
Asthma, Eczema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raja Sivamani, MD, MS, CAT principal investigator
University of California, Davis, Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetyl Hexapeptide-8 in people with Oily Skin, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician graded shine score (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.