A Clinical Trial to Determine the Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea

Condition(s) targeted: Rosacea

Intervention: doxycycline (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: CollaGenex Pharmaceuticals

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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in total inflammatory lesion count

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Starting date: June 2004
Ending date: April 2005
Last updated: August 18, 2005