Acne VulgarisPhase 1/2NCT02293018
Pharmacokinetic Study of MTC896 Gel in Subjects With Acne
A Phase 1/2 study testing 0.75% (w/w) MTC896 Gel Once Daily, 0.75% (w/w) MTC896 Gel Twice Daily and 1.5% (w/w) MTC896 Gel Once Daily in people with Acne Vulgaris, run by Mimetica Pty Limited at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- 0.75% (w/w) MTC896 Gel Once Daily, 0.75% (w/w) MTC896 Gel Twice Daily and 1.5% (w/w) MTC896 Gel Once Daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2014to Jan 2015
- Phase
- Phase 1/2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
DermResearch
Austin, Texas, 78759
J&S Studies
College Station, Texas, 77845
Premier Clinical Research
Spokane, Washington, 99204
About this study
Official title: 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.
- Conditions
- Acne Vulgaris
- Being tested
- 0.75% (w/w) MTC896 Gel Once Daily, 0.75% (w/w) MTC896 Gel Twice Daily, 1.5% (w/w) MTC896 Gel Once Daily
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.75% (w/w) MTC896 Gel Once DailyDrug
0.75% (w/w) MTC896 Gel Twice DailyDrug
1.5% (w/w) MTC896 Gel Once DailyDrug
| Study group | Role | What they receive |
|---|---|---|
| 0.75% (w/w) MTC896 Gel once daily | Experimental | Subjects will apply topically daily 0.75% (w/w) MTC896 Gel Receives: Drug: 0.75% (w/w) MTC896 Gel Once Daily |
| 0.75% (w/w) MTC896 Gel twice daily | Experimental | Subjects will apply topically twice daily 0.75% (w/w) MTC896 Gel Receives: Drug: 0.75% (w/w) MTC896 Gel Twice Daily |
| 1.5% (w/w) MTC896 Gel once daily | Experimental | Subjects will apply topically daily 1.5% (w/w) MTC896 Gel Receives: Drug: 1.5% (w/w) MTC896 Gel Once Daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic: maximum concentration (Cmax) of MTC896 in the plasma after 28 days of treatment
The primary pharmacokinetic outcome measure will be the maximum concentration (Cmax) of MTC896 in the plasma after 28 days of treatment.
Measured: 4 weeks
Secondary outcomes (1)
Safety and tolerability: Adverse event incidence and severity, local tolerability, laboratory test results, vital signs, 12-lead electrocardiogram
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)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mimetica Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293018
- Sponsor's protocol ID
- MCL14001
- Status last verified
- Apr 2015
- First submitted
- 11 Nov 2014
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02293018
- Acronym / sponsor ID
- MCL14001
- Conditions
- Acne Vulgaris
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mimetica Pty LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 Nov 2014 (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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.75% (w/w) MTC896 Gel once daily | Experimental | Drug: 0.75% (w/w) MTC896 Gel Once DailySubjects will apply topically daily 0.75% (w/w) MTC896 Gel |
| 0.75% (w/w) MTC896 Gel twice daily | Experimental | Drug: 0.75% (w/w) MTC896 Gel Twice DailySubjects will apply topically twice daily 0.75% (w/w) MTC896 Gel |
| 1.5% (w/w) MTC896 Gel once daily | Experimental | Drug: 1.5% (w/w) MTC896 Gel Once DailySubjects will apply topically daily 1.5% (w/w) MTC896 Gel |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (20 listed)
- 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;
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 |
|---|---|---|
| 0.75% (w/w) MTC896 Gel Once Daily | Drug | 0.75% (w/w) MTC896 Gel once daily |
| 0.75% (w/w) MTC896 Gel Twice Daily | Drug | 0.75% (w/w) MTC896 Gel twice daily |
| 1.5% (w/w) MTC896 Gel Once Daily | Drug | 1.5% (w/w) MTC896 Gel once daily |
Primary outcome
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.
1 secondary outcome
Safety and tolerability: Adverse event incidence and severity, local tolerability, laboratory test results, vital signs, 12-lead electrocardiogram
Time frame: 4 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 17 Apr 2015.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 0.75% (w/w) MTC896 Gel Once Daily, 0.75% (w/w) MTC896 Gel Twice Daily and 1.5% (w/w) MTC896 Gel Once Daily in people with Acne Vulgaris, run by Mimetica Pty Limited at 3 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 17 inclusion and 20 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 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pharmacokinetic: maximum concentration (Cmax) of MTC896 in the plasma after 28 days of treatment (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 17 Apr 2015.