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Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00495313
Enrollment
91
Registered
2007-07-03
Start date
2007-03-31
Completion date
2007-12-31
Last updated
2008-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rosacea

Keywords

Rosacea

Brief 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%

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%

Interventions

DRUGdoxycycline

COL-101, QD plus metronidazole

Sponsors

CollaGenex Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 8-40 total lesions * erythema * telangiectasia

Exclusion criteria

* non-pregnant, non-lactating * achlorhydric * gastric by-pass surgery * allergy to study medications * drug/alcohol abuse * use of proton pump inhibitors

Design outcomes

Primary

MeasureTime frame
Change in total lesion count from Baseline at the study endpoint16 weeks

Secondary

MeasureTime frame
Change in total lesion count (papules + pustules + nodules) from Baseline at each visit4 weeks, 8 weeks, 12 weeks
Change in Investigator's Global Assessment from Baseline at the study endpoint16 weeks
Change in Clinician's Erythema Assessment score from Baseline at the study endpoint16 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026