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OpenTrials
Completed

NCT Number: NCT00126399

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

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.

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxycycline

Drug

Primary outcomes

  1. Change in total inflammatory lesion count

Secondary outcomes

  1. Change from baseline in erythema scale scores

  2. change from baseline in the investigator's global assessment (IGA) score

  3. proportion of patients being clear or near-clear at endpoint

Sponsors and collaborators

Lead sponsor

CollaGenex Pharmaceuticals

Industry

Registry information

Important dates

Study start
2004
Study completion
2005
First posted
Aug 4, 2005
Registry last updated
Aug 19, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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