Acne VulgarisPhase 2NCT01362010
Clinical Study to Evaluate Tolerability and Safety of FXFM244 and to Monitor Clinical Effect in Acne Vulgaris Patients
A Phase 2 study testing Topical Minocycline Foam FXFM244 in people with Acne Vulgaris, run by Vyne Therapeutics Inc. at 3 sites in Israel.
Trial summary
The purpose of this study is to evaluate the tolerability and safety and to determine whether FXFM244 Antibiotic Foam is effective in the treatment of Acne Vulgaris. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Topical Minocycline Foam FXFM244
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 3 sitesIsrael
- Study dates
- Jan 2012to Jul 2013
- 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 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A clinical diagnosis of Acne Vulgaris with facial involvement.
- A minimum of 20 but not more than 50 inflammatory lesions on the face (papules and/ or pustules).
- A minimum of 25 but not more than 100 non-inflammatory lesions on the face (opened and/or closed comedones).
- No significant nodulocystic acne on the face (≤ 2 lesions).
- A score of >3 (Moderate) on the Investigator's Global Assessment Scale.
- Patient is male or female between the ages of 12 to 25.
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- No known medical conditions that, in the Investigator's opinion could interfere with study participation.
- Patient is willing to refrain from use of all other topical acne medications or antibiotics during the study.
- Patient is willing to refrain from use of moisturizers, new brands of make-up, creams, lotions, powders or any topical product other than the assigned treatment to the treatment area.
- Patient is willing and able to comply with all requirement of the protocol.
- Patient is willing and able to give written informed consent prior to participation in the study.
- If female of childbearing potential, willing to use an acceptable form of birth control during the study. Use of oral contraceptives must remain constant within 3 month prior to baseline and throughout the study.
Who cannot join
- Acne Conglobata, Acne Fulminas, secondary acne (chloracne, drug induced acne), or severe acne requiring systemic treatment.
- Presence of any facial skin condition that would interfere with the diagnosis or assessment of Acne Vulgaris (e.g. rosacea, dermatitis, psoriasis, squamos cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
- Excessive facial hair (beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of Acne Vulgaris.
- Known or suspected hypersensitivity to Minocycline or any of the excipients in the Study Medication.
- Concomitant medication:
- Use within 6 month prior to baseline of topical retinoids, oral retinoids (Accutane®) or therapeutic Protocol No. FX2010-03 Foamix Ltd. Page 8 of 28 Confidential Ver: 02 Oct-31-2011 vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
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- Use of systemic steroids, systemic antibiotics, systemic treatment for Acne Vulgaris, systemic antiinflammatory agents within 4 weeks prior to baseline.
- Use of topical steroids, α-hydroxy/glycolic acid, benzoyl peroxide, topical antibiotics, topical treatment for Acne Vulgaris, topical anti-inflammatory agents within 2 weeks prior to baseline.
- Use for less than 3 month prior to baseline of estrogens or change in oral contraceptives therapy within less than 3 month prior to baseline;
- Use on the face of: cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids or X-ray therapy within 4 weeks prior to baseline..
- Alcohol or drug abuse, according to assessment by the investigator.
- Use of another investigational drug within 30 days prior to baseline.
- Pregnant or lactating women.
- Use of tanning booths, sunbathing, or excessive exposure to the sun should be prohibited during the study.
- Participation in clinical trial in the previous month.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Lev Yasmin clinic
Netanya
Sourasky medical center
Tel Aviv
Tel-Nordau Clalit health services
Tel Aviv
About this study
Official title: Pilot, Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Range Finding Study, to Evaluate the Tolerability and Safety of FXFM244 Antibiotic Foam and to Monitor Its Clinical Effect in Acne Vulgaris Patients
The purpose of this study is to evaluate the tolerability and safety and to determine whether FXFM244 Antibiotic Foam is effective in the treatment of Acne Vulgaris.
Read the detailed description
This is a phase IIa prospective, multicenter, randomized, double blind, placebo controlled, parallel group, dose range finding clinical study to evaluate the safety, tolerability and efficacy of Minocycline Foam 1% and 4% for the treatment of Acne Vulgaris.
The study consists of a screening / baseline visit, a treatment period where patients will be treated topically on the facial skin areas affected by acne twice daily for 12 weeks, followed by a post-treatment follow up visit 4 weeks after end of treatment. The first dose will be applied in the presence of the study investigator or his assignee. Subsequent applications will be made by the patients.
- Conditions
- Acne Vulgaris
- Being tested
- Topical Minocycline Foam FXFM244
- Keywords
- Acne, Acne Vulgaris, Topical, Minocycline, Foam, Phase II
- Medical subject headings
- Acne Vulgaris, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Minocycline Foam FXFM244Drug
Also called FXFM244 antibiotic foam
Topically applied once a day.
| Study group | Role | What they receive |
|---|---|---|
| Topical Minocycline Foam FXFM244 - 4% | Experimental | Active ingredient: Minocycline Concentration: 4% Route: Topical Dosage schedule: Once daily, evening. Receives: Drug: Topical Minocycline Foam FXFM244 |
| Topical Minocycline Foam FXFM244 - 1% | Experimental | Active ingredient: Minocycline Concentration: 1% Route: Topical Dosage schedule: Once daily, evening. Receives: Drug: Topical Minocycline Foam FXFM244 |
| Placebo foam | Placebo comparator | Active ingredient: None Route: Topical Dosage schedule: Once daily, evening Receives: Drug: Topical Minocycline Foam FXFM244 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in lesions count
The change in lesion count (inflammatory, non-inflammatory, and total) after 12 weeks of treatment compared to baseline
Measured: 12 weeks
Investigator global assessment
Physician's Global Improvement Assessment
Measured: 12 weeks
Secondary outcomes (4)
% change in lesions count
The % change in lesions count (inflammatory, non-inflammatory, and total) after 12 weeks of treatment compared to baseline
Measured: 12 weeks
Global assessment of improvement by photographs
The photographs will assist in comparison of efficacy at subsequent visits compared to baseline
Measured: 12 weeks
Subject-reported outcome assessment
Measured: 12 weeks
Subjects safety
safety parameters will be assessed by
- Physical examination
- Vital signs (HR, BP, Body temperature)
- Adverse events recording
- Clinical assessment of skin irritation
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 posted27 May 2011 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionJul 2013
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vyne Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Shiri, Prof., Principal investigator, Clalit Health ServicesEli Sprecher, MD, Principal investigator, Sourasky Medical CenterAvner Shemer, Prof., Principal investigator, Lev Yasmin clinic, Netanya, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362010
- Sponsor's protocol ID
- FX2010-03
- Status last verified
- Aug 2013
- First submitted
- 26 May 2011
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Range Finding Study, to Evaluate the Tolerability and Safety of FXFM244 Antibiotic Foam and to Monitor Its Clinical Effect in Acne Vulgaris Patients
- ClinicalTrials.gov ID
- NCT01362010
- Acronym / sponsor ID
- FX2010-03
- Conditions
- Acne Vulgaris
- Keywords
- Acne, Acne Vulgaris, Topical, Minocycline, Foam, Phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 May 2011 (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 evaluate the tolerability and safety and to determine whether FXFM244 Antibiotic Foam is effective in the treatment of Acne Vulgaris.
Detailed description
This is a phase IIa prospective, multicenter, randomized, double blind, placebo controlled, parallel group, dose range finding clinical study to evaluate the safety, tolerability and efficacy of Minocycline Foam 1% and 4% for the treatment of Acne Vulgaris.
The study consists of a screening / baseline visit, a treatment period where patients will be treated topically on the facial skin areas affected by acne twice daily for 12 weeks, followed by a post-treatment follow up visit 4 weeks after end of treatment. The first dose will be applied in the presence of the study investigator or his assignee. Subsequent applications will be made by the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topical Minocycline Foam FXFM244 - 4% | Experimental | Drug: Topical Minocycline Foam FXFM244Active ingredient: Minocycline Concentration: 4% Route: Topical Dosage schedule: Once daily, evening. |
| Topical Minocycline Foam FXFM244 - 1% | Experimental | Drug: Topical Minocycline Foam FXFM244Active ingredient: Minocycline Concentration: 1% Route: Topical Dosage schedule: Once daily, evening. |
| Placebo foam | Placebo comparator | Drug: Topical Minocycline Foam FXFM244Active ingredient: None Route: Topical Dosage schedule: Once daily, evening |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- A clinical diagnosis of Acne Vulgaris with facial involvement.
- A minimum of 20 but not more than 50 inflammatory lesions on the face (papules and/ or pustules).
- A minimum of 25 but not more than 100 non-inflammatory lesions on the face (opened and/or closed comedones).
- No significant nodulocystic acne on the face (≤ 2 lesions).
- A score of >3 (Moderate) on the Investigator's Global Assessment Scale.
Key exclusion criteria (15 listed)
- Acne Conglobata, Acne Fulminas, secondary acne (chloracne, drug induced acne), or severe acne requiring systemic treatment.
- Presence of any facial skin condition that would interfere with the diagnosis or assessment of Acne Vulgaris (e.g. rosacea, dermatitis, psoriasis, squamos cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
- Excessive facial hair (beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of Acne Vulgaris.
- Known or suspected hypersensitivity to Minocycline or any of the excipients in the Study Medication.
- Concomitant medication:
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 |
|---|---|---|
| Topical Minocycline Foam FXFM244Also: FXFM244 antibiotic foamTopically applied once a day. | Drug | Placebo foam, Topical Minocycline Foam FXFM244 - 1%, Topical Minocycline Foam FXFM244 - 4% |
Primary outcome
Decrease in lesions count
Time frame: 12 weeks
The change in lesion count (inflammatory, non-inflammatory, and total) after 12 weeks of treatment compared to baseline
Investigator global assessment
Time frame: 12 weeks
Physician's Global Improvement Assessment
4 secondary outcomes
% change in lesions count
Time frame: 12 weeks
Global assessment of improvement by photographs
Time frame: 12 weeks
Subject-reported outcome assessment
Time frame: 12 weeks
Subjects safety
Time frame: 12 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 15 Aug 2013.
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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.
Joseph Shiri, Prof. principal investigator
Clalit Health Services
Eli Sprecher, MD principal investigator
Sourasky Medical Center
Avner Shemer, Prof. principal investigator
Lev Yasmin clinic, Netanya, Israel
3 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 Topical Minocycline Foam FXFM244 in people with Acne Vulgaris, run by Vyne Therapeutics Inc. at 3 sites in Israel.
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 12 inclusion and 15 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 15 Aug 2013. 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 Israel. 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?
Decrease in lesions count (time frame: 12 weeks). The study lists 2 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 15 Aug 2013; AzTrials last refreshed its copy on 7 Nov 2026.