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Acne VulgarisPhase 2NCT02395549

A Study to Determine the Efficacy of Topically Applied MTC896 Gel in Subjects With Acne Vulgaris

A Phase 2 study testing 0.375% (w/w) MTC896 Gel, 0.75% (w/w) MTC896 Gel and 1.5% (w/w) MTC896 Gel in people with Acne Vulgaris, run by Mimetica Pty Limited at 20 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is designed to investigate the efficacy, safety and tolerability of MTC896 Gel in subjects with acne. In this study, MTC896 Gel will be applied at 3 concentrations, twice daily (bid) for 12 weeks and compared against a vehicle control. Read more about this study

Who is it for?
Ages 16 to 65 years
Conditions the study is for
Acne Vulgaris
What is being tested?
0.375% (w/w) MTC896 Gel, 0.75% (w/w) MTC896 Gel and 1.5% (w/w) MTC896 Gel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
364 participants
Where
20 sitesUnited States
Study dates
Apr 2015to Aug 2016
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 16 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Is a male or nonpregnant, non-lactating, non-breastfeeding female, 16 to 65 years of age, inclusive, at the time of screening;
  • Has provided written informed consent/assent (which includes consent for photographs, if applicable, to be taken at Baseline and end-of-treatment/end-of-study [EOT/EOS] visits);
  • Has been diagnosed with mild-to-severe acne vulgaris defined as:
  • At least 20 inflammatory lesions,
  • At least 20 noninflammatory lesions,
  • ≤ 2 nodular lesions, and
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  • Investigator Global Assessment of 2 or greater;
  • Is willing to comply with the requirements of the protocol;
  • If female and of child-bearing potential or premenarcheal, has a negative urine pregnancy test at Screening and Baseline / Day 1 and is willing to use effective contraception during the study and for 30 days after the last study medication application. Females are considered to be of childbearing potential unless surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation), diagnosed as infertile, or are postmenopausal for at least 1 year; (Acceptable methods of birth control are defined as: abstinence, oral contraceptives, contraceptive patches/implants, Depo-Provera®, double barrier methods (e.g. condom and spermicide) or an intrauterine device (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 medication 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 on the face during the study (continued use of make-up is permitted but may not be changed within 2 weeks prior to the study period or during the entire study period);
  • Is willing to avoid sun exposure and to protect the face with a hat/visor; sunscreen use is recommended/allowed when sun exposure cannot be avoided;
  • 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 (e.g. benzoyl peroxide, salicylic acid) are allowed for treatment of acne of the back, shoulders, and chest only.

Who cannot join

  • People who would otherwise qualify for the study, but are living in the same household as a study subject, are not allowed to participate in the study;
  • Pregnant or lactating or plan to become pregnant within 1 month (30 days) of study completion;
  • Known allergy/sensitivity to any of the study medication components;
  • Any skin condition which may interfere with the evaluation of safety or of acne vulgaris (e.g. 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;
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  • Active cystic acne or acne conglobata, acne fulminans, and secondary acne;
  • 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;
  • Is 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;
  • Within 9 months (270 days) prior to Baseline and throughout the study:
  • Oral retinoid use (e.g. isotretinoin);
  • Within 6 months (180 days) prior to Baseline and throughout the study:
  • Treatment with Vitamin A supplements greater than 10,000 units/day;
  • Within 3 months (90 days) prior to Baseline and throughout the study:
  • Use of androgen receptor blockers (such as spironolactone or flutamide);
  • Initiation of treatment with hormonal therapy or dose change to hormonal therapy;
  • Dose and frequency of use of any hormonal therapy started more than 3 months (90 days) prior to Baseline must remain unchanged throughout the study;
  • Hormonal therapies include, but are not limited to, testosterone, anabolic steroids, birth control pills;
  • Within 8 weeks (56 days) prior to Baseline and throughout the study:
  • Facial procedures (chemical or laser peel, microdermabrasion, etc.);
  • Within 4 weeks (28 days) prior to Baseline and throughout the study:
  • Treatment with systemic corticosteroids (including intranasal and inhaled corticosteroids);
  • Treatment with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs; Note: Non-steroidal anti-inflammatory drugs (NSAIDs) and aspirin use on an as-needed basis and if not used consecutively for >14 days prior to Baseline is acceptable and does not require washout. Low dose (81 mg) aspirin taken daily is acceptable.
  • Prescription topical retinoid use on the face (e.g. tretinoin, tazarotene, adapalene);
  • Antifungals, antiretrovirals and antibiotics included in the CYP 3A4 and CYP 3A5;
  • Within 2 weeks (14 days) prior to Baseline and throughout the study:
  • Treatment with topical prescription antibiotics (e.g. dapsone, clindamycin, erythromycin, or sulfacetamide);
  • 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 1 day prior to Baseline and throughout the study:
  • Grapefruit juice which is included in the CYP 3A4 and CYP 3A5.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Austin, Texas

  • Study site

    College Station, Texas

  • Study site

    Denver, Colorado

  • Study site

    Hershey, Pennsylvania

  • Study site

    High Point, North Carolina

  • Study site

    Johnston, Rhode Island

  • Study site

    Louisville, Kentucky

  • Study site

    Minneapolis, Minnesota

  • Study site

    Nashville, Tennessee

  • Study site

    Plano, Texas

  • Study site

    Sacramento, California

  • Study site

    Salt Lake City, Utah

  • Study site

    San Diego, California, 92108

  • Study site

    San Diego, California, 92123

  • Study site

    Sanford, Florida

  • Study site

    Spokane, Washington

  • Study site

    Warren, Michigan

  • Study site

    Warwick, Rhode Island

  • Study site

    West Palm Beach, Florida

Other trials in United States

About this study

This study is designed to investigate the efficacy, safety and tolerability of MTC896 Gel in subjects with acne. In this study, MTC896 Gel will be applied at 3 concentrations, twice daily (bid) for 12 weeks and compared against a vehicle control.

Conditions
Acne Vulgaris
Being tested
0.375% (w/w) MTC896 Gel, 0.75% (w/w) MTC896 Gel, 1.5% (w/w) MTC896 Gel, Vehicle Control Gel
Medical subject headings
Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.375% (w/w) MTC896 GelDrug

    0.375% (w/w) MTC896 Gel

  • 0.75% (w/w) MTC896 GelDrug

    0.75% (w/w) MTC896 Gel

  • 1.5% (w/w) MTC896 GelDrug

    1.5% (w/w) MTC896 Gel

  • Vehicle Control GelDrug

Study groups in NCT02395549
Study groupRoleWhat they receive
0.375% (w/w) MTC896 GelExperimental0.375% (w/w) MTC896 Gel will be applied bid to the whole face for 12 weeks.
Receives: Drug: 0.375% (w/w) MTC896 Gel
0.75% (w/w) MTC896 GelExperimental0.75% (w/w) MTC896 Gel will be applied bid to the whole face for 12 weeks.
Receives: Drug: 0.75% (w/w) MTC896 Gel
1.5% (w/w) MTC896 GelExperimental1.5% (w/w) MTC896 Gel will be applied bid to the whole face for 12 weeks.
Receives: Drug: 1.5% (w/w) MTC896 Gel
Vehicle Control GelPlacebo comparatorVehicle Control Gel will be applied bid to the whole face for 12 weeks.
Receives: Drug: Vehicle Control Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute change from baseline in inflammatory lesion counts

    Measured: Week 12

  2. Absolute change from baseline in noninflammatory lesion counts

    Measured: Week 12

  3. Proportion of subjects with Investigator"s Global Assessment (IGA) success

    i.e., who achieved a minimum 2-grade improvement from baseline

    Measured: Week 12

Secondary outcomes (10)

  1. Percent change from baseline in inflammatory lesion counts

    Measured: Weeks 4, 8 and 12

  2. Percent change from baseline in noninflammatory lesion counts

    Measured: Weeks 4, 8 and 12

  3. Percent change from baseline in total lesion counts

    Measured: Weeks 4, 8 and 12

  4. Absolute change from baseline in inflammatory lesion counts

    Measured: Weeks 4 and 8

  5. Absolute change from baseline in noninflammatory lesion counts

    Measured: Weeks 4 and 8

  6. Absolute change from baseline in total lesion counts

    Measured: Weeks 4, 8 and 12

  7. Proportion of subjects with IGA success

    i.e. who achieved a minimum 2-grade improvement from baseline

    Measured: Weeks 4 and 8

  8. Time to IGA success

    Measured: Week 12

  9. Proportion of subjects who achieved at least a 2 grade reduction and an IGA score of clear or almost clear

    Measured: Weeks 4, 8 and 12

  10. Proportion of subjects who achieved a "Clear" or "Almost Clear" IGA score

    Measured: Weeks 4, 8 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionJun 2016
  4. Study completionAug 2016 (estimated)

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
364 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02395549
Sponsor's protocol ID
MCL15001
Status last verified
Jun 2016
First submitted
17 Mar 2015
Last updated
16 Jun 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 0.375% (w/w) MTC896 Gel, 0.75% (w/w) MTC896 Gel and 1.5% (w/w) MTC896 Gel in people with Acne Vulgaris, run by Mimetica Pty Limited at 20 sites 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 16 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites 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.

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?

Results are not available in the source record.

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?

Absolute change from baseline in inflammatory lesion counts (time frame: Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02395549.

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 16 Jun 2016.

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