- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02293018
Pharmacokinetic Study of MTC896 Gel in Subjects With Acne
April 16, 2015 updated by: Mimetica Pty Limited
A Randomized, Single-Blind, Phase 2 Study to Determine the Safety, Tolerability, and Systemic Exposure of 3 Dose Regimens of Topically Applied MTC896 Gel in Subjects With Acne Vulgaris
The purpose of this study is to determine the pharmacokinetic properties of topically applied MTC896 Gel following application of 0.75% (w/w) MTC896 Gel once daily and twice daily and 1.5% (w/w) once daily over 4 weeks in the treatment of acne.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
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Austin, Texas, United States, 78759
- DermResearch
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College Station, Texas, United States, 77845
- J&S Studies
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Washington
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Spokane, Washington, United States, 99204
- Premier Clinical Research
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Is a male or nonpregnant female who is at least 18 years of age at the time of screening;
- Has provided written informed consent (which includes consent for photographs) to be taken at Baseline, EOT, and EOS visits;
- Has a casual level (CL) of sebum ≥ 150 μg/cm2 on the forehead as measured with the Sebumeter®;
- Has an SER of ≥ 150 μg/cm2/h on the forehead as measured with the Sebumeter®;
Has been diagnosed with inflammatory acne vulgaris of mild to moderate severity defined as:
- At least 20 inflammatory lesions,
- At least 20 noninflammatory lesions, and
- Investigator Global Assessment of 2 or greater;
- Is willing to comply with the requirements of the protocol;
- If female and of child-bearing potential, has a negative urine/serum pregnancy test at Screening and Baseline/Day 1 and is willing to use effective contraception during the study. Females are considered to be of childbearing potential unless surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation), diagnosed as infertile, have the same sex partner or a vasectomized male partner, are postmenopausal for at least 1 year, or are abstinent; (Acceptable methods of birth control are defined as: abstinence, oral contraceptives, contraceptive patches/implants; Depo-Provera®, double barrier methods (eg, condom and spermicide) or an IUD. Birth control method must have been stable/unchanged for 12 weeks prior to Baseline and must remain unchanged during study participation);
- If male, has been vasectomized or agrees to use an accepted method of birth control with female partner during study participation and for 30 days after the last study drug application;
- Is in good health and free from any disease which, in the opinion of the Investigator, would put the subject at risk if participating in the study;
- Is 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;
- Is willing to abstain from using any facial treatment products or personal care products (moisturizer, sunscreen, hair spray, etc) on the face during the study;
- Is willing to avoid sun exposure and to protect the face with a hat/visor;
- If male, must agree to shave the treatment area and must agree not to alter his routine shaving regimen for the duration of the study;
- Is willing to refrain from using any treatments, other than the study medication, including antibiotics, for acne present on the face. Topical acne treatments that do not have significant or measurable systemic absorption (eg, benzoyl peroxide, salicylic acid) are allowed for treatment of acne of the back, shoulders, and chest only;
Exclusion Criteria:
- Pregnant or lactating or plan to become pregnant within 1 month of study completion;
- Known allergy/sensitivity to any of the drug product components;
- Any skin condition which may interfere with the evaluation of safety or of acne vulgaris (eg, rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne or folliculitis);
- Excessive facial hair that would interfere with diagnosis or assessment of acne vulgaris;
- Excessive sun exposure, in the opinion of the Investigator or, use of tanning booths;
- Active cystic acne or acne congoblata, acne fulminans, and secondary acne;
- Two or more active nodular lesions;
- Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator;
- Participation in an investigational drug study within 30 days prior to Screening;
- Are a poor medical risk because of other systemic diseases or active uncontrolled infections, in the opinion of the Investigator;
- Any other condition which, in the judgment of the Investigator, would put the subject at unacceptable risk for participation in the study;
- Treatment with any Cytochrome P450 3A4 (CYP3A4) or Cytochrome P450 3A5 (CYP3A5) inhibitor;
- Treatment with over-the-counter (OTC) topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid on the face within 2 weeks prior to Baseline;
- Treatment with systemic corticosteroids (including intranasal and inhaled corticosteroids) within 4 weeks prior to Baseline;
- Treatment with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs within 4 weeks prior to Baseline;
- Prescription topical retinoid use on the face within 4 weeks of Baseline (eg, tretinoin, tazarotene, adapalene);
- Initiation of treatment with hormonal therapy or dose change to hormonal therapy within 12 weeks prior to Baseline. Dose and frequency of use of any hormonal therapy started more than 12 weeks prior to Baseline must remain unchanged throughout the study. Hormonal therapies include, but are not limited to, testosterone, anabolic steroids, and estrogenic and progestational agents such as birth control pills;
- Use of androgen receptor blockers (such as spironolactone or flutamide) within 3 months prior to Baseline;
- Oral retinoid use (eg, isotretinoin) within 9 months prior to Baseline or vitamin A supplements greater than 10,000 units/day within 6 months of Baseline;
- Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks or during the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 0.75% (w/w) MTC896 Gel once daily
Subjects will apply topically daily 0.75% (w/w) MTC896 Gel
|
|
Experimental: 0.75% (w/w) MTC896 Gel twice daily
Subjects will apply topically twice daily 0.75% (w/w) MTC896 Gel
|
|
Experimental: 1.5% (w/w) MTC896 Gel once daily
Subjects will apply topically daily 1.5% (w/w) MTC896 Gel
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic: maximum concentration (Cmax) of MTC896 in the plasma after 28 days of treatment
Time Frame: 4 weeks
|
The primary pharmacokinetic outcome measure will be the maximum concentration (Cmax) of MTC896 in the plasma after 28 days of treatment.
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4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability: Adverse event incidence and severity, local tolerability, laboratory test results, vital signs, 12-lead electrocardiogram
Time Frame: 4 weeks
|
Adverse event incidence and severity, local tolerability, laboratory test results (hematology, clinical chemistry, lipid profile, urinalysis), vital signs (systolic and diastolic blood pressure, heart rate, respiratory rate), 12-lead electrocardiogram (ECG)
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
November 11, 2014
First Submitted That Met QC Criteria
November 13, 2014
First Posted (Estimate)
November 18, 2014
Study Record Updates
Last Update Posted (Estimate)
April 17, 2015
Last Update Submitted That Met QC Criteria
April 16, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCL14001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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