Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens

CollaGenex

Status and phase: Completed; Phase 4

Conditions: Rosacea

Treatments: Drug: doxycycline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00495313

COL101-ROSE-401

Details and patient eligibility

About

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%

Full 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%

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

91 participants in 2 patient groups

Cohort 1: doxycycline

Active Comparator group

Description:

Vibramycin plus metronidazole

Treatment:

Drug: doxycycline

Drug: doxycycline

Cohort 2

Active Comparator group

Description:

Oracea® delayed release plus metronidazole

Treatment:

Drug: doxycycline

Drug: doxycycline