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NCT00126399 Clinical Trial

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

Rosacea Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00126399
Other study ID # COL-101-ROSE-301+302
Secondary ID
Status Completed
Phase Phase 3
First received August 2, 2005
Last updated August 18, 2005
Start date June 2004
Est. completion date April 2005

Study information
Verified date August 2005
Source CollaGenex Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 528
Est. completion date April 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• doxycycline

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
CollaGenex Pharmaceuticals

Outcome
Type Measure Description Time frame Safety issue
Primary Change in total inflammatory lesion count
Secondary Change from baseline in erythema scale scores
Secondary change from baseline in the investigator's global assessment (IGA) score
Secondary proportion of patients being clear or near-clear at endpoint
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