RosaceaPhase 2NCT01134991
Study to Evaluate the Safety and Efficacy of Topical Minocycline FXFM244 in Rosacea Patients
A Phase 2 study testing Topical Minocycline Foam FXFM244 in people with Rosacea, run by Vyne Therapeutics Inc. at 1 site in Israel.
Trial summary
Acne rosacea is a chronic acneiform disorder affecting both the skin and the eye. It is a syndrome of undetermined etiology characterized by both vascular and papulopustular components involving the face and occasionally the neck and upper trunk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea
- What is being tested?
- Topical Minocycline Foam FXFM244
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2010to Mar 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical diagnosis of moderate to severe facial rosacea as determined by:
- At least 8 but no more than 50 total papules and/or pustules (inflammatory lesions)
- Presence of moderate to severe erythema
- Presence of telangiectasia.
- An Overall Rosacea Severity score ≥2.5
- Patient is male or female over 18 years of age.
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- No known medical conditions that, in the Investigator's opinion could interfere with study participation
- 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
Who cannot join
- Presence of skin diseases at or near the investigational area
- Immunosuppressed state or other serious systemic disease
- Signs and/or symptoms of systemic infection
- Concomitant medication:
- Use of oral and/or topical antibiotic treatment within 14 days prior to study entry.
- Use of any topical anti-rosacea agent except antibiotics within 14 days prior to study entry.
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- Use of cyproterone acetate, CPA-containing contraceptives (e.g. Diane) or other corticosteroids (during the last 3 months);
- Use of retinoids (during the last 4 weeks)
- Use of artificial sun bath or having a sun holiday during the last 2 weeks
- Alcohol or drug abuse, according to assessment by the investigator
- Known or suspected hypersensitivity to Minocycline or any of the excipients in the Study Medication
- Use of another investigational drug within 30 days prior to entry into this study
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot, 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 Moderate to Severe Rosacea Patients
Acne rosacea is a chronic acneiform disorder affecting both the skin and the eye. It is a syndrome of undetermined etiology characterized by both vascular and papulopustular components involving the face and occasionally the neck and upper trunk.
This is a pilot phase II study to evaluate the tolerability and safety and to monitor the clinical efficacy of Topical Minocycline Foam FXFM244 in moderate to severe Rosacea patients.
Read the detailed description
A Pilot, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Range Finding Study. The study will involve three treatment groups. Eligible patients will be randomized to receive either FXFM244 - 1%, FXFM244 - 4% or Placebo, in a blinded fashion. Patients will be treated twice daily for 12 weeks. Following the screening period and baseline visit, study subjects will return at Weeks 3, 6, 9 and 12. A follow up visit will take place at week 16. At each visit, patients will be evaluated via lesion count, global assessment tolerability and safety.
- Conditions
- Rosacea
- Being tested
- Topical Minocycline Foam FXFM244
- Keywords
- rosacea, topical, minocycline, foam, phase II
- Medical subject headings
- Rosacea, 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
FXFM244 - 1%, FXFM244 - 4% or Placebo to be applied twice daily during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Topical Minocycline Foam FXFM244 Placebo | Placebo comparator | Minocycline Foam FXFM244 Placebo Receives: Drug: Topical Minocycline Foam FXFM244 |
| Topical Minocycline Foam FXFM244, 1% | Experimental | Minocycline Foam FXFM244, 1% Receives: Drug: Topical Minocycline Foam FXFM244 |
| Topical Minocycline Foam FXFM244, 4% | Experimental | Minocycline Foam FXFM244, 4% Receives: Drug: Topical Minocycline Foam FXFM244 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in signs and symptoms of rosacea
Measured: 12 weeks
Secondary outcomes (1)
The severity of the overall rosacea condition will be measured at baseline and at all follow-up visits. The severity will be assessed and graded based on the scales for erythema, telangiectases and number of papulopustular lesions
Measured: 0, 3, 6, 9 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2014
Why it stopped: Difficulty in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 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
- NCT01134991
- Sponsor's protocol ID
- 0041-10LND /FX2010-02
- Status last verified
- Aug 2010
- First submitted
- 26 May 2010
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, 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 Moderate to Severe Rosacea Patients
- ClinicalTrials.gov ID
- NCT01134991
- Acronym / sponsor ID
- 0041-10LND /FX2010-02
- Conditions
- Rosacea
- Keywords
- rosacea, topical, minocycline, foam, phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruitment
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Mar 2014 (actual)
- First posted
- 2 Jun 2010 (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.
Acne rosacea is a chronic acneiform disorder affecting both the skin and the eye. It is a syndrome of undetermined etiology characterized by both vascular and papulopustular components involving the face and occasionally the neck and upper trunk.
This is a pilot phase II study to evaluate the tolerability and safety and to monitor the clinical efficacy of Topical Minocycline Foam FXFM244 in moderate to severe Rosacea patients.
Detailed description
A Pilot, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Range Finding Study. The study will involve three treatment groups. Eligible patients will be randomized to receive either FXFM244 - 1%, FXFM244 - 4% or Placebo, in a blinded fashion. Patients will be treated twice daily for 12 weeks. Following the screening period and baseline visit, study subjects will return at Weeks 3, 6, 9 and 12. A follow up visit will take place at week 16. At each visit, patients will be evaluated via lesion count, global assessment tolerability and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topical Minocycline Foam FXFM244 Placebo | Placebo comparator | Drug: Topical Minocycline Foam FXFM244Minocycline Foam FXFM244 Placebo |
| Topical Minocycline Foam FXFM244, 1% | Experimental | Drug: Topical Minocycline Foam FXFM244Minocycline Foam FXFM244, 1% |
| Topical Minocycline Foam FXFM244, 4% | Experimental | Drug: Topical Minocycline Foam FXFM244Minocycline Foam FXFM244, 4% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with clinical diagnosis of moderate to severe facial rosacea as determined by:
- Patient is male or female over 18 years of age.
- No known medical conditions that, in the Investigator's opinion could interfere with study participation
- 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
Key exclusion criteria (13 listed)
- Presence of skin diseases at or near the investigational area
- Immunosuppressed state or other serious systemic disease
- Signs and/or symptoms of systemic infection
- Concomitant medication:
- Use of artificial sun bath or having a sun holiday during the last 2 weeks
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 FXFM244FXFM244 - 1%, FXFM244 - 4% or Placebo to be applied twice daily during 12 weeks | Drug | Topical Minocycline Foam FXFM244 Placebo, Topical Minocycline Foam FXFM244, 1%, Topical Minocycline Foam FXFM244, 4% |
Primary outcome
Improvement in signs and symptoms of rosacea
Time frame: 12 weeks
1 secondary outcome
The severity of the overall rosacea condition will be measured at baseline and at all follow-up visits. The severity will be assessed and graded based on the scales for erythema, telangiectases and number of papulopustular lesions
Time frame: 0, 3, 6, 9 and 12 weeks
Results and safety
The study was stopped early (reason given: Difficulty in recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
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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.
1 site 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 Rosacea, run by Vyne Therapeutics Inc. at 1 site 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 9 inclusion and 13 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: stopped early, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Difficulty in recruitment). 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?
Improvement in signs and symptoms of rosacea (time frame: 12 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 26 Aug 2015.