RosaceaPhase 2NCT00621218
A Study to Determine the Safety and Efficacy of Atralin (Tretinoin 0.05%) Gel for the Treatment of Rosacea
A Phase 2 study testing tretinoin gel 0.05% in people with Rosacea, run by Coria Laboratories, Ltd. at 1 site in United States.
Trial summary
To compare the efficacy and safety of tretinoin gel 0.05% to its vehicle when dosed once or twice daily in female subjects with rosacea. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Rosacea
- What is being tested?
- tretinoin gel 0.05%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Dec 2008
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age 18-65
- Diagnosed with classical, centrofacial, erythemato-telangiectatic rosacea
Who cannot join
- Male, females less than 18 years
- Females over 65 years
- No diagnosed rosacea
Trial locations and contacts
1 site in 1 country.
United States1 site
Product Investigations, Inc.
Conshohocken, Pennsylvania, 19428
About this study
Official title: A Pilot Study to Compare Tretinoin Gel, 0.05% to Tretinoin Gel Vehicle When Dosed Once or Twice Daily in Female Subjects With Classical Rosacea
To compare the efficacy and safety of tretinoin gel 0.05% to its vehicle when dosed once or twice daily in female subjects with rosacea.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tretinoin gel 0.05%Drug
Apply tretinoin gel, 0.05% topically once or twice daily to female subjects with rosacea
vehicleDrug
Apply Atralin Gel vehicle topically once or twice daily to female subjects with rosacea.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: tretinoin gel 0.05% |
| 2 | Placebo comparator | Not described Receives: Drug: vehicle |
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: 16 weeks
Secondary outcomes (1)
Changes in various skin parameters
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionApr 2008
- Study completionDec 2008
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coria Laboratories, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Morris V Shelanski, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621218
- Sponsor's protocol ID
- 9320-010-002
- Status last verified
- Dec 2008
- First submitted
- 12 Feb 2008
- Last updated
- 18 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Compare Tretinoin Gel, 0.05% to Tretinoin Gel Vehicle When Dosed Once or Twice Daily in Female Subjects With Classical Rosacea
- ClinicalTrials.gov ID
- NCT00621218
- Acronym / sponsor ID
- 9320-010-002
- Conditions
- Rosacea
- Keywords
- tretinoin, efficacy, safety, rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Coria Laboratories, Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Feb 2008 (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.
To compare the efficacy and safety of tretinoin gel 0.05% to its vehicle when dosed once or twice daily in female subjects with rosacea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: tretinoin gel 0.05% |
| 2 | Placebo comparator | Drug: vehicle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Age 18-65
- Diagnosed with classical, centrofacial, erythemato-telangiectatic rosacea
Key exclusion criteria (3 listed)
- Male, females less than 18 years
- Females over 65 years
- No diagnosed rosacea
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 |
|---|---|---|
| tretinoin gel 0.05%Apply tretinoin gel, 0.05% topically once or twice daily to female subjects with rosacea | Drug | 1 |
| vehicleApply Atralin Gel vehicle topically once or twice daily to female subjects with rosacea. | Drug | 2 |
Primary outcome
Improvement in signs and symptoms of rosacea
Time frame: 16 weeks
1 secondary outcome
Changes in various skin parameters
Time frame: 16 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 18 Dec 2008.
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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.
Morris V Shelanski, MD principal investigator
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 tretinoin gel 0.05% in people with Rosacea, run by Coria Laboratories, Ltd. at 1 site 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 3 inclusion and 3 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 18 Dec 2008. 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 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?
Improvement in signs and symptoms of rosacea (time frame: 16 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 18 Dec 2008.