Acne VulgarisPhase 2NCT04104685
A Study to Compare FCD105 Foam to Minocycline 3% Foam, Adapalene 0.3% Foam and Vehicle Foam.
A Phase 2 study testing FCD105, 3% Minocycline Foam and 0.3% Adapalene Foam in people with Acne Vulgaris, run by Vyne Therapeutics Inc. at 35 sites in United States.
Trial summary
A study comparing FCD105 to 3% minocycline foam, 0.3% adapalene foam and vehicle foam in patients ≥ 12 years old for the treatment of moderate-to-severe acne. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- FCD105, 3% Minocycline Foam and 0.3% Adapalene Foam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 446 participants
- Where
- 35 sitesUnited States
- Study dates
- 18 Sep 2019to 3 Mar 2020
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Has facial acne vulgaris with all of the following:
- 20 to 50 inflammatory lesions (papules and/or pustules) on the face.
- 25 to 100 non-inflammatory lesions (open and closed comedones) on the face.
- IGA score of moderate (3) to severe (4).
- No more than two active nodules on the face.
- Willing to use only the supplied non-medicated cleanser and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study
Who cannot join
- Female who is pregnant or lactating, or is planning a pregnancy during the study.
- Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face that could interfere with the clinical evaluations.
- Facial hair (eg, beard, mustache, etc.) that could interfere with the clinical evaluations.
- Sunburn on the face.
- Severe systemic disease as assessed by the Investigator that might interfere with the conduct of the study or the interpretation of the results.
- Subjects who have a documented history of any of the following:
Show all 27Show fewer
- Allergy to tetracycline-class antibiotics or to any ingredient in the study drug.
- Pseudomembranous colitis or antibiotic-associated colitis.
- Hepatitis or clinically significant liver damage or clinically significant renal impairment.
- Known or suspected premalignant or malignant disease (excluding successfully treated skin cancers).
- Subjects who have used the following medications:
- Within 1 week prior to randomization:
- Medicated facial cleansers on the face.
- Topical acne treatments on the face (other than those listed below).
- Within 4 weeks prior to randomization:
- Topical retinoids on the face.
- Topical anti-inflammatories and/or corticosteroids on the face.
- Topical corticosteroids on body areas other than the face for more than 15 consecutive days and on more than 10% of the body surface area. In body folds, such as axillary and inguinal regions, only mild topical steroids are allowed for short term use (≤15 consecutive days).
- Systemic antibiotics.
- Systemic acne treatments.
- Within 12 weeks prior to randomization:
- Systemic retinoids.
- Systemic corticosteroids (Note: Intranasal and inhaled corticosteroids may be used throughout the study if the subject is on a stable dose).
- Use of sauna during the 2 weeks prior to randomization.
- Epilation of the face within 2 weeks prior to randomization.
- Folliculitis on the face.
- Documented history of depression that is not, in the opinion of the Investigator, currently adequately controlled with medication
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Foamix Institution #110
Arlington, Texas, 76011
Foamix Institution #126
Baton Rouge, Louisiana, 70809
Foamix Institution #134
Bryant, Arkansas, 72022
Foamix Institution #114
Clinton Township, Michigan, 48038
Foamix Institution #117
College Station, Texas, 77845
Foamix Institution #106
Encino, California, 91436
Foamix Institution #103
Fremont, California, 94538
Foamix Institution #111
Fridley, Minnesota, 55432
Foamix Institution #133
Gresham, Oregon, 97030
Foamix Institution #107
Hialeah, Florida, 33016
Foamix Institution #104
High Point, North Carolina, 27262
Foamix Institution #122
Huntington Beach, California, 92647
Foamix Institution #125
Johnston, Rhode Island, 02919
Foamix Institution #127
Lake City, Florida, 32055
Foamix Institution #102
Las Vegas, Nevada, 89148
Foamix Institution #131
Layton, Utah, 84041
Foamix Institution #123
Louisville, Kentucky, 40241
Foamix Institution #109
Manhattan Beach, California, 90266
Foamix Institution #101
Miami, Florida, 33126
Foamix Institution #135
Miami Beach, Florida, 33162
Foamix Institution #119
Mt. Pleasant, South Carolina, 29464
Foamix Institution #130
New Albany, Indiana, 47150
Foamix Institution #124
New Orleans, Louisiana, 70115
Foamix Institution #115
New York, New York, 10022
Foamix Institution #112
Pflugerville, Texas, 78660
Foamix Institution #116
Plainfield, Indiana, 46168
Foamix Institution #121
Rogers, Arkansas, 72758
Foamix Institution #105
San Antonio, Texas, 78213
Foamix Institution #132
San Diego, California, 92123
Foamix Institution #118
Sanford, Florida, 32771
Foamix Institution #113
Spokane, Washington, 99202
Foamix Institution #108
Stony Brook, New York, 11790
Foamix Institution #120
Sunrise, Florida, 33351
Foamix Institution #128
Tampa, Florida, 33607
Foamix Institution #136
Watertown, Massachusetts, 02472
About this study
Official title: A Prospective, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of a Combination of 3% Minocycline and 0.3% Adapalene Topical Foam Formulation for the Treatment of Moderate-to-Severe Acne (Study FX2016 40)
A study comparing FCD105 to 3% minocycline foam, 0.3% adapalene foam and vehicle foam in patients ≥ 12 years old for the treatment of moderate-to-severe acne.
- Conditions
- Acne Vulgaris
- Being tested
- FCD105, 3% Minocycline Foam, 0.3% Adapalene Foam, Vehicle Foam
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCD105Combination product
Experimental combination
3% Minocycline FoamDrug
Active Comparator
0.3% Adapalene FoamDrug
Active Comparator
Vehicle FoamOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| FCD105 Foam | Experimental | FCD105 Foam Receives: Combination Product: FCD105 |
| 3% Minocycline Foam | Active comparator | 3% Minocycline Foam Receives: Drug: 3% Minocycline Foam |
| 0.3% Adapalene Foam | Active comparator | 0.3% Adapalene Foam Receives: Drug: 0.3% Adapalene Foam |
| Vehicle Foam | Placebo comparator | Vehicle Foam Receives: Other: Vehicle Foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from Baseline in inflammatory lesion counts at week 12
Statistical superiority of FCD105 vs. vehicle in the absolute change from Baseline in inflammatory lesion counts at Visit 4 (Week12/End of Treatment)
Measured: 12 weeks
Absolute change from Baseline in non-inflammatory lesion counts at week 12
Statistical superiority of FCD105 vs. vehicle in the absolute change from Baseline in non-inflammatory lesion counts at Visit 4 (Week12/End of Treatment)
Measured: 12 weeks
Investigator's Global Assessment (IGA) Treatment Success at Week 12
Statistical superiority of FCD105 vs. vehicle in in IGA Treatment Success at Visit 4 (Week 12/End of Treatment), where success is defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from Baseline.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start18 Sep 2019
- Primary completion28 Feb 2020
- Study completion3 Mar 2020
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vyne Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104685
- Sponsor's protocol ID
- FX2016-40
- Status last verified
- Feb 2021
- First submitted
- 24 Sep 2019
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of a Combination of 3% Minocycline and 0.3% Adapalene Topical Foam Formulation for the Treatment of Moderate-to-Severe Acne (Study FX2016 40)
- ClinicalTrials.gov ID
- NCT04104685
- Acronym / sponsor ID
- FX2016-40
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 26 Sep 2019 (actual)
- 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.
A study comparing FCD105 to 3% minocycline foam, 0.3% adapalene foam and vehicle foam in patients ≥ 12 years old for the treatment of moderate-to-severe acne.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FCD105 Foam | Experimental | Combination Product: FCD105FCD105 Foam |
| 3% Minocycline Foam | Active comparator | Drug: 3% Minocycline Foam3% Minocycline Foam |
| 0.3% Adapalene Foam | Active comparator | Drug: 0.3% Adapalene Foam0.3% Adapalene Foam |
| Vehicle Foam | Placebo comparator | Other: Vehicle FoamVehicle Foam |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Has facial acne vulgaris with all of the following:
- No more than two active nodules on the face.
- Willing to use only the supplied non-medicated cleanser and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study
Key exclusion criteria (27 listed)
- Female who is pregnant or lactating, or is planning a pregnancy during the study.
- Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face that could interfere with the clinical evaluations.
- Facial hair (eg, beard, mustache, etc.) that could interfere with the clinical evaluations.
- Sunburn on the face.
- Severe systemic disease as assessed by the Investigator that might interfere with the conduct of the study or the interpretation of the results.
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 |
|---|---|---|
| FCD105Experimental combination | Combination product | FCD105 Foam |
| 3% Minocycline FoamActive Comparator | Drug | 3% Minocycline Foam |
| 0.3% Adapalene FoamActive Comparator | Drug | 0.3% Adapalene Foam |
| Vehicle FoamPlacebo | Other | Vehicle Foam |
Primary outcome
Absolute change from Baseline in inflammatory lesion counts at week 12
Time frame: 12 weeks
Statistical superiority of FCD105 vs. vehicle in the absolute change from Baseline in inflammatory lesion counts at Visit 4 (Week12/End of Treatment)
Absolute change from Baseline in non-inflammatory lesion counts at week 12
Time frame: 12 weeks
Statistical superiority of FCD105 vs. vehicle in the absolute change from Baseline in non-inflammatory lesion counts at Visit 4 (Week12/End of Treatment)
Investigator's Global Assessment (IGA) Treatment Success at Week 12
Time frame: 12 weeks
Statistical superiority of FCD105 vs. vehicle in in IGA Treatment Success at Visit 4 (Week 12/End of Treatment), where success is defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from Baseline.
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 Feb 2021.
- Individual participant dataSharing planned: No
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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.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FCD105, 3% Minocycline Foam and 0.3% Adapalene Foam in people with Acne Vulgaris, run by Vyne Therapeutics Inc. at 35 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 6 inclusion and 27 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 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 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?
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?
Absolute change from Baseline in inflammatory lesion counts at week 12 (time frame: 12 weeks). 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?
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 Feb 2021.