A Clinical Trial to Determine the Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00126399 |
Recruitment Status :
Completed
First Posted : August 4, 2005
Last Update Posted : August 19, 2005
|
Sponsor:
CollaGenex Pharmaceuticals
Information provided by:
CollaGenex Pharmaceuticals
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief 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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rosacea | Drug: doxycycline | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 528 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Study Start Date : | June 2004 |
Study Completion Date : | April 2005 |
Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics:
Rosacea
MedlinePlus related topics:
Rosacea
Primary Outcome Measures :
- Change in total inflammatory lesion count
Secondary Outcome Measures :
- 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
Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
No Contacts or Locations Provided
ClinicalTrials.gov Identifier: | NCT00126399 |
Other Study ID Numbers: |
COL-101-ROSE-301+302 |
First Posted: | August 4, 2005 Key Record Dates |
Last Update Posted: | August 19, 2005 |
Last Verified: | August 2005 |
Keywords provided by CollaGenex Pharmaceuticals:
rosacea acne rosacea |
Additional relevant MeSH terms:
Rosacea Skin Diseases Doxycycline Anti-Bacterial Agents |
Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |