Acne VulgarisPhase 3NCT04960930
To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris
A Phase 3 study testing FMX101 in people with Acne Vulgaris, run by Cutia Therapeutics (Shanghai) Co., Ltd at 29 sites in China.
Trial summary
This is a randomized, multicenter, double-blind, vehicle-controlled, 2-arm study to evaluate the safety and efficacy in 12 weeks of FMX101 minocycline foam, 4%, compared to vehicle, in the treatment of subjects with moderate to severe facial acne vulgaris. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- FMX101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 372 participants
- Where
- 29 sitesChina
- Study dates
- 17 Sep 2021to 14 Oct 2022
- Phase
- Phase 3
- 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 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Has completed and signed an appropriately administered Informed Consent Form (ICF) prior to any study-related procedures. Subjects less than 18 years of age (or as required by state law) must sign an Assent Form for the study and a parent or legal guardian must sign the ICF.
- Has facial acne vulgaris with:
- 20 to 50 inflammatory lesions (papules, pustules, and nodules)
- 25 to 100 non-inflammatory lesions (open and closed comedones)
- No more than 2 nodules on the face
- IGA score of moderate (3) to severe (4)
- Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin 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
- Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.
- Sunburn on the face.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
China29 sites
China-Japan Friendship Hospital
Beijin, Beijin, 100029
Beijing Tsinghua Changgung Hospital
Beijin, Beijin, 102218
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100144
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
The First Bethune Hosptial of Jilin University
Changchun, Jiling, 130061
The Third Xiangya Hospital Of Central South University
Changsha, Hunan, 410013
West China Hospital Sichuan University
Chengdu, Sichuan, 610044
The Southwest Hospital Of Amu
Chongqing, Chongqing Municipality, 400038
The First Affiliated Hospital Of Chongqing Medical University
Chongqing, Chongqing Municipality, 400042
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, 310009
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310020
The Second Affiliated Hosptial Zhejiang University School Of Medicine
Hangzhou, Zhejiang
Qilu Hospital of Shandong University
Jinan, Shandong, 250063
Institute of Dermatology Chinese Academy of Medical Sciences
Nanjin, Jiangsu, 210042
The Affiliated Hosptial of Qingdao University
Qingdao, Shandong, 266003
Shanghai Medical College of Fudan University
Shanghai, Shanghai Municipality, 200040
Shanghai Skin Disease Hospital Skin Disease Hospital of Tongji University
Shanghai, Shanghai Municipality, 200050
The First Hosptial of China Medical University
Shenyang, Liaoning, 110001
Shengjin Hospital of China Medical University
Shenyang, Liaoning, 110004
The Second Hospital Of Hebei Medical University
Shijiazhuang, Hebei, 050004
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjing, Tianjing, 300120
Wuxi People's Hospital
Wuxi, Jiangsu, 214023
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710004
Dermatology Hosptial of Southern Medical University
Yuexiu, Guangdong, 510091
About this study
Official title: A Phase 3, Multi-center, Randomized, Double-Blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of Topical Administration of Minocycline Hydrochloride Foam (4%) in the Treatment of Moderate-to-Severe Acne Vulgaris
This is a randomized, multicenter, double-blind, vehicle-controlled, 2-arm study to evaluate the safety and efficacy in 12 weeks of FMX101 minocycline foam, 4%, compared to vehicle, in the treatment of subjects with moderate to severe facial acne vulgaris.
Read the detailed description
Qualified subjects will be randomized to receive 1 of the following 2 treatments:
- FMX101 4% minocycline foam
- Vehicle foam
Subjects with qualifying lesion counts and Investigator's Global Assessments (IGA) of acne severity scores and will be assigned to 1 of 2 treatments according to the randomization schedule. Subjects will apply the assigned study drug topically once daily for 12 weeks as directed. Subjects will be advised to apply the study drug at approximately the same time each day, preferably in the evening at bedtime. Both the Investigator and subject will be blinded to the study drug identity.
Subjects will return for visits at Weeks 1, 2, 4, 6, 8, and 12. At the discretion of the clinic staff, for the convenience of subjects or clinic staff, visits can be scheduled to occur 2 days before or after the nominal schedule date for the Weeks 1, 2, 4, 8 and 12 visits. Efficacy evaluations (acne lesion counts and IGAs) will be performed at each visit during the study.
- Conditions
- Acne Vulgaris
- Being tested
- FMX101
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMX101Drug
topically once daily
| Study group | Role | What they receive |
|---|---|---|
| FMX101 | Experimental | FMX101 4% minocycline foam Receives: Drug: FMX101 |
| Vehicle Foam | Placebo comparator | Vehicle Foam Receives: Drug: FMX101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ILC
The efficacy assessments will inflammation lesion counts at week12
Measured: Week12
Secondary outcomes (6)
Investigator Global Assessment (IGA)
Severity of acne vulgaris assessed by Investigator Global Assessment (IGA) IGA Scale for Acne Vulgaris for study is 0-5, score 0 is clear and normal, and score 5 is very severe.
Measured: week 12
nILC
The efficacy assessments will non-inflammation lesion counts at baseline and week12
Measured: week 12
ILC week4
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 4
Measured: week 4
ILC week8
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 8
Measured: week 8
Investigator Global Assessment (IGA) week4
IGA Treatment Success at Week 4 IGA Scale for Acne Vulgaris for study is 0-5, score 0 is clear and normal, and score 5 is very severe.
Measured: Week 4
Investigator Global Assessment (IGA) week8
IGA Treatment Success at Week 8 IGA Scale for Acne Vulgaris for study is 0-5, score 0 is clear and normal, and score 5 is very severe.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start17 Sep 2021
- Primary completion27 Sep 2022
- Study completion14 Oct 2022
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Drug: FMX101 FMX101, 4% minocycline foam Drug: Vehicle Foam Vehicle Foam
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutia Therapeutics (Shanghai) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960930
- Sponsor's protocol ID
- CU-10201-301
- Status last verified
- Feb 2023
- First submitted
- 9 Jul 2021
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-center, Randomized, Double-Blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of Topical Administration of Minocycline Hydrochloride Foam (4%) in the Treatment of Moderate-to-Severe Acne Vulgaris
- ClinicalTrials.gov ID
- NCT04960930
- Acronym / sponsor ID
- CU-10201-301
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Cutia Therapeutics (Shanghai) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 14 Oct 2022 (actual)
- First posted
- 14 Jul 2021 (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.
This is a randomized, multicenter, double-blind, vehicle-controlled, 2-arm study to evaluate the safety and efficacy in 12 weeks of FMX101 minocycline foam, 4%, compared to vehicle, in the treatment of subjects with moderate to severe facial acne vulgaris.
Detailed description
Qualified subjects will be randomized to receive 1 of the following 2 treatments:
- FMX101 4% minocycline foam
- Vehicle foam
Subjects with qualifying lesion counts and Investigator's Global Assessments (IGA) of acne severity scores and will be assigned to 1 of 2 treatments according to the randomization schedule. Subjects will apply the assigned study drug topically once daily for 12 weeks as directed. Subjects will be advised to apply the study drug at approximately the same time each day, preferably in the evening at bedtime. Both the Investigator and subject will be blinded to the study drug identity.
Subjects will return for visits at Weeks 1, 2, 4, 6, 8, and 12. At the discretion of the clinic staff, for the convenience of subjects or clinic staff, visits can be scheduled to occur 2 days before or after the nominal schedule date for the Weeks 1, 2, 4, 8 and 12 visits. Efficacy evaluations (acne lesion counts and IGAs) will be performed at each visit during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Drug: FMX101 FMX101, 4% minocycline foam Drug: Vehicle Foam Vehicle Foam
| Arm | Type | Receives |
|---|---|---|
| FMX101 | Experimental | Drug: FMX101FMX101 4% minocycline foam |
| Vehicle Foam | Placebo comparator | Drug: FMX101Vehicle Foam |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Has completed and signed an appropriately administered Informed Consent Form (ICF) prior to any study-related procedures. Subjects less than 18 years of age (or as required by state law) must sign an Assent Form for the study and a parent or legal guardian must sign the ICF.
- Has facial acne vulgaris with:
- Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin 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 (2 listed)
- Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.
- Sunburn on the face.
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 |
|---|---|---|
| FMX101topically once daily | Drug | FMX101, Vehicle Foam |
Primary outcome
ILC
Time frame: Week12
The efficacy assessments will inflammation lesion counts at week12
6 secondary outcomes
Investigator Global Assessment (IGA)
Time frame: week 12
nILC
Time frame: week 12
ILC week4
Time frame: week 4
ILC week8
Time frame: week 8
Investigator Global Assessment (IGA) week4
Time frame: Week 4
Investigator Global Assessment (IGA) week8
Time frame: Week 8
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 28 Sep 2023.
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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.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FMX101 in people with Acne Vulgaris, run by Cutia Therapeutics (Shanghai) Co., Ltd at 29 sites in China.
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 7 inclusion and 2 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
ILC (time frame: Week12). 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 28 Sep 2023.