RosaceaPhase 3NCT00126399
A Clinical Trial to Determine the Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea
A Phase 3 study testing doxycycline in people with Rosacea, run by CollaGenex Pharmaceuticals.
Trial summary
The objective of this study is to evaluate the safety and efficacy of 40 mg doxycycline controlled-release capsules administered once daily for the treatment of rosacea compared with a placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea
- What is being tested?
- doxycycline
- How many people
- 528 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Apr 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Healthy patients with rosacea
- Males and females ≥18 years of age
- 10 to 40 papules and pustules and ≤2 nodules
- Score of 2 to 4 on the IGA
- Presence of telangiectasia
- Moderate to severe erythema
Main Exclusion Criteria:
- Use of topical acne treatments or topical or systemic antibiotics
- Use of systemic retinoids within 90 days of baseline
- Use of an investigational drug within 90 days of baseline
- Pregnant or nursing women
- Women of childbearing potential not using an adequate form of contraception
- Change in method of contraception within 4 months of baseline
- Known hypersensitivity to tetracyclines
- Surgeries that bypass or exclude the duodenum or achlorhydria
About this study
The objective of this study is to evaluate the safety and efficacy of 40 mg doxycycline controlled-release capsules administered once daily for the treatment of rosacea compared with a placebo.
- Conditions
- Rosacea
- Being tested
- doxycycline
- Keywords
- rosacea, acne rosacea
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxycyclineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total inflammatory lesion count
Secondary outcomes (3)
Change from baseline in erythema scale scores
change from baseline in the investigator's global assessment (IGA) score
proportion of patients being clear or near-clear at endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2005 (estimated)
- Study startJun 2004
- Study completionApr 2005
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 528 participants
Sponsor and investigators
- Lead sponsor
- CollaGenex Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126399
- Sponsor's protocol ID
- COL-101-ROSE-301+302
- Status last verified
- Aug 2005
- First submitted
- 2 Aug 2005
- Last updated
- 19 Aug 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Determine the Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea
- ClinicalTrials.gov ID
- NCT00126399
- Acronym / sponsor ID
- COL-101-ROSE-301+302
- Conditions
- Rosacea
- Keywords
- rosacea, acne rosacea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 528 participants
- Lead sponsor
- CollaGenex PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Study completion
- Apr 2005
- First posted
- 4 Aug 2005 (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 objective of this study is to evaluate the safety and efficacy of 40 mg doxycycline controlled-release capsules administered once daily for the treatment of rosacea compared with a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| doxycycline | Drug | – |
Primary outcome
Change in total inflammatory lesion count
3 secondary outcomes
Change from baseline in erythema scale scores
change from baseline in the investigator's global assessment (IGA) score
proportion of patients being clear or near-clear at endpoint
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 19 Aug 2005.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing doxycycline in people with Rosacea, run by CollaGenex Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Aug 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Change in total inflammatory lesion count. 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 19 Aug 2005.