Oily SkinPhase 2NCT01254162
Proof of Concept Study of MTC896 Gel to Reduce Sebum Production on the Forehead of Healthy Male Volunteers
A Phase 2 study testing MTC896 Gel in people with Oily Skin and Seborrhea, run by Mimetica Pty Limited at 1 site in United States.
Trial summary
To determine the potential of topically applied 0.75% (w/w) MTC896 Gel to reduce sebum production on the forehead of healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- What is being tested?
- MTC896 Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Aug 2011
- Phase
- Phase 2
- 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 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Are healthy males;
- 2. Are between 18 and 65 years of age;
- 3. Have self-perceived oily skin confirmed by a clinical assessment;
- 4. Have an average Sebumeter® reading of ≥ 220 µg/cm2 on the forehead;
- 5. Have a negative urine drug screening test result;
- 6. Have a negative HIV and hepatitis screening test result;
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- 7. Agree to use adequate contraceptive precautions (ie, use of condoms) during the conduct of the study;
- 8. Have a body mass index (BMI) of 19 to 34 kg/m2;
- 9. Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events;
- 10. Are willing to abstain from using any facial treatment products or personal care products (moisturizer, sunscreen, hair spray, etc) on the forehead during the study;
- 11. Are willing to avoid sun exposure and to protect the forehead with a hat/visor;
- 12. Are fluent in the English language;
- 13. Complete a standard Medical Screening form as well as a Medical Personal History form; and
- 14. Read, understand, and provide a signed informed consent.
Who cannot join
- 1. Have any visible skin disease at the application site which, in the opinion of the investigator, will interfere with the study evaluations;
- 2. Have a history of photosensitive reactions or a history of cutaneous or systemic lupus or other disorders frequently associated with photosensitivity;
- 3. Are not willing to refrain from using systemic/topical analgesics such as aspirin (81 mg daily aspirin will be allowed at the discretion of the PI), Aleve, Motrin, Advil, or Nuprin for 24 hours prior to and during the study (use of acetaminophen will be permitted);
- 4. Are using systemic/topical corticosteroids in the test area for 3 weeks prior to and during the study, or systemic/ antihistamines for 24 hours prior to and during the study;
- 5. Are using topical retinoids, products containing benzoyl peroxide, salicylic acid, or alpha-hydroxy acids for 2 weeks prior to and during the study; or systemic retinoids within 3 months prior;
- 6. Are using any medication which, in the opinion of the investigator, will interfere with the study evaluations;
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- 7. Have seborrheic dermatitis and/or active atopic dermatitis/eczema in or around the test sites;
- 8. Have a known allergy and/or hypersensitivity to constituents present in the study products;
- 9. Have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
- 10. Have received treatment for any type of internal cancer within 5 years prior to study enrollment;
- 11. Have a history of, or are currently being treated for skin cancer;
- 12. Are currently participating in any clinical testing; and/or
- 13. Have received any investigational treatment(s) within 4 weeks prior to study enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 4-Week, Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Evaluate the Potential of Topically Applied 0.75% (w/w) MTC896 Gel to Reduce Sebum Production on the Forehead of Healthy Male Volunteers
To determine the potential of topically applied 0.75% (w/w) MTC896 Gel to reduce sebum production on the forehead of healthy male volunteers.
Read the detailed description
This is a single-center, randomized, double-blind, placebo-controlled proof-of-concept study of the investigational product (0.75% (w/w) MTC896 Gel) compared to a placebo control. Subjects will be randomized to 1 of 2 treatment groups, 0.75% (w/w) MTC896 Gel or Placebo. Approximately 134 subjects will be enrolled to yield 60 completed subjects in each group. One group will receive once daily topical applications of 0.75% (w/w) MTC896 Gel to the forehead for 28 consecutive days, and the other will receive placebo under the identical regimen. Enrollment will be staggered to allow monitoring of safety and tolerability. A lead cohort will include approximately 20 subjects (10 in the MTC896 Group and 10 in the Placebo Group). Application on additional subjects will not be initiated until the lead cohort has completed the study.
- Being tested
- MTC896 Gel
- Keywords
- Oily Skin, Sebum
- Medical subject headings
- Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTC896 GelDrug
0.75% w/w gel applied daily for 28 days to the forehead
| Study group | Role | What they receive |
|---|---|---|
| Placebo Gel | Experimental | Not described Receives: Drug: MTC896 Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
A 20% reduction in sebum production as measured by the Sebumeter
Measured: 28 days
Secondary outcomes (1)
Assess the safety and tolerability of the product when applied daily to the forehead for 28 days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2011
- Study completionAug 2011
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mimetica Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan S Dosik, MD, Principal investigator, TKL Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254162
- Sponsor's protocol ID
- MCL10001
- Status last verified
- Sep 2014
- First submitted
- 2 Dec 2010
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-Week, Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Evaluate the Potential of Topically Applied 0.75% (w/w) MTC896 Gel to Reduce Sebum Production on the Forehead of Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01254162
- Acronym / sponsor ID
- MCL10001
- Keywords
- Oily Skin, Sebum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Mimetica Pty LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 6 Dec 2010 (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.
To determine the potential of topically applied 0.75% (w/w) MTC896 Gel to reduce sebum production on the forehead of healthy male volunteers.
Detailed description
This is a single-center, randomized, double-blind, placebo-controlled proof-of-concept study of the investigational product (0.75% (w/w) MTC896 Gel) compared to a placebo control. Subjects will be randomized to 1 of 2 treatment groups, 0.75% (w/w) MTC896 Gel or Placebo. Approximately 134 subjects will be enrolled to yield 60 completed subjects in each group. One group will receive once daily topical applications of 0.75% (w/w) MTC896 Gel to the forehead for 28 consecutive days, and the other will receive placebo under the identical regimen. Enrollment will be staggered to allow monitoring of safety and tolerability. A lead cohort will include approximately 20 subjects (10 in the MTC896 Group and 10 in the Placebo Group). Application on additional subjects will not be initiated until the lead cohort has completed the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placebo Gel | Experimental | Drug: MTC896 Gel |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1. Are healthy males;
- 2. Are between 18 and 65 years of age;
- 3. Have self-perceived oily skin confirmed by a clinical assessment;
- 4. Have an average Sebumeter® reading of ≥ 220 µg/cm2 on the forehead;
- 5. Have a negative urine drug screening test result;
Key exclusion criteria (13 listed)
- 1. Have any visible skin disease at the application site which, in the opinion of the investigator, will interfere with the study evaluations;
- 2. Have a history of photosensitive reactions or a history of cutaneous or systemic lupus or other disorders frequently associated with photosensitivity;
- 3. Are not willing to refrain from using systemic/topical analgesics such as aspirin (81 mg daily aspirin will be allowed at the discretion of the PI), Aleve, Motrin, Advil, or Nuprin for 24 hours prior to and during the study (use of acetaminophen will be permitted);
- 4. Are using systemic/topical corticosteroids in the test area for 3 weeks prior to and during the study, or systemic/ antihistamines for 24 hours prior to and during the study;
- 5. Are using topical retinoids, products containing benzoyl peroxide, salicylic acid, or alpha-hydroxy acids for 2 weeks prior to and during the study; or systemic retinoids within 3 months prior;
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 |
|---|---|---|
| MTC896 Gel0.75% w/w gel applied daily for 28 days to the forehead | Drug | Placebo Gel |
Primary outcome
A 20% reduction in sebum production as measured by the Sebumeter
Time frame: 28 days
1 secondary outcome
Assess the safety and tolerability of the product when applied daily to the forehead for 28 days
Time frame: 28 days
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 12 Sep 2014.
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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.
Jonathan S Dosik, MD principal investigator
TKL Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MTC896 Gel in people with Oily Skin and Seborrhea, run by Mimetica Pty Limited 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 14 inclusion and 13 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 12 Sep 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
A 20% reduction in sebum production as measured by the Sebumeter (time frame: 28 days). 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 12 Sep 2014.