RosaceaPhase 4NCT00495313
Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens
A Phase 4 study testing doxycycline in people with Rosacea, run by CollaGenex Pharmaceuticals at 7 sites in United States.
Trial summary
To compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1% Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rosacea
- What is being tested?
- doxycycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2007to Dec 2007
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 8-40 total lesions
- erythema
- telangiectasia
Who cannot join
- non-pregnant, non-lactating
- achlorhydric
- gastric by-pass surgery
- allergy to study medications
- drug/alcohol abuse
- use of proton pump inhibitors
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Angela Moore
Arlington, Texas, 76011
William Abramovits
Dallas, Texas, 75230
James Del Rosso
Las Vegas, Nevada, 89052
Joel Schlessinger
Omaha, Nebraska, 68144
Bernard Goffe
Seattle, Washington, 98101
William Werschler
Spokane, Washington, 99204
Douglas Forsha
West Jordan, Utah, 84088
About this study
Official title: Determine the Effects of COL-101 Administered Once Daily With Metronidazole Topical Gel, 1% Versus Doxycycline Hyclate 100 mg Administered Once Daily With Metronidazole Topical Gel, 1% in Patients With Moderate to Severe Rosacea
To compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1%
Read the detailed description
Compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1%
- Conditions
- Rosacea
- Being tested
- doxycycline
- Keywords
- 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
Also called Vibramycin, 100 mg, QD plus metornidazole
COL-101, QD plus metronidazole
doxycyclineDrug
Also called Oracea® 40 mg plus metronidazole
40 mg with metronidazole QD
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: doxycycline | Active comparator | Vibramycin plus metronidazole Receives: Drug: doxycycline |
| Cohort 2 | Active comparator | Oracea® delayed release plus metronidazole Receives: Drug: doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total lesion count from Baseline at the study endpoint
Measured: 16 weeks
Secondary outcomes (3)
Change in Investigator's Global Assessment from Baseline at the study endpoint
Measured: 16 weeks
Change in Clinician's Erythema Assessment score from Baseline at the study endpoint
Measured: 16 weeks
Change in total lesion count (papules + pustules + nodules) from Baseline at each visit
Measured: 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2007
- Study completionDec 2007
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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- CollaGenex Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christopher V Powala, JD, Study chair, CollaGenex Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495313
- Sponsor's protocol ID
- COL101-ROSE-401
- Status last verified
- Dec 2008
- First submitted
- 29 Jun 2007
- Last updated
- 16 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determine the Effects of COL-101 Administered Once Daily With Metronidazole Topical Gel, 1% Versus Doxycycline Hyclate 100 mg Administered Once Daily With Metronidazole Topical Gel, 1% in Patients With Moderate to Severe Rosacea
- ClinicalTrials.gov ID
- NCT00495313
- Acronym / sponsor ID
- COL101-ROSE-401
- Conditions
- Rosacea
- Keywords
- Rosacea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- CollaGenex PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 3 Jul 2007 (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 safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1%
Detailed description
Compare the safety and efficacy of two treatment regimens: 1) COL-101 and metronidazole gel 1%; 2) Doxycycline hyclate 100 mg and metronidazole gel 1%
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: doxycycline | Active comparator | Drug: doxycyclineVibramycin plus metronidazole |
| Cohort 2 | Active comparator | Drug: doxycyclineOracea® delayed release plus metronidazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 8-40 total lesions
- erythema
- telangiectasia
Key exclusion criteria (6 listed)
- non-pregnant, non-lactating
- achlorhydric
- gastric by-pass surgery
- allergy to study medications
- drug/alcohol abuse
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 |
|---|---|---|
| doxycyclineAlso: Vibramycin, 100 mg, QD plus metornidazoleCOL-101, QD plus metronidazole | Drug | Cohort 1: doxycycline |
| doxycyclineAlso: Oracea® 40 mg plus metronidazole40 mg with metronidazole QD | Drug | Cohort 2 |
Primary outcome
Change in total lesion count from Baseline at the study endpoint
Time frame: 16 weeks
3 secondary outcomes
Change in Investigator's Global Assessment from Baseline at the study endpoint
Time frame: 16 weeks
Change in Clinician's Erythema Assessment score from Baseline at the study endpoint
Time frame: 16 weeks
Change in total lesion count (papules + pustules + nodules) from Baseline at each visit
Time frame: 4 weeks, 8 weeks, 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 16 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.
Christopher V Powala, JD study chair
CollaGenex Pharmaceuticals
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing doxycycline in people with Rosacea, run by CollaGenex Pharmaceuticals at 7 sites 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 6 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 16 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 7 sites 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 lesion count from Baseline at the study endpoint (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 16 Dec 2008.