NCT00126399

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
528

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2005

Completed
Last Updated

August 19, 2005

Status Verified

August 1, 2005

First QC Date

August 2, 2005

Last Update Submit

August 18, 2005

Conditions

Rosacea

Keywords

rosaceaacne rosacea

Outcome Measures

Primary Outcomes (1)

  • Change in total inflammatory lesion count

Secondary Outcomes (3)

  • 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

Interventions

doxycyclineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy patients with rosacea
  • Males and females ≥18 years of age
  • to 40 papules and pustules and ≤2 nodules
  • Score of 2 to 4 on the IGA
  • Presence of telangiectasia
  • Moderate to severe erythema

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rosacea

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 2, 2005

First Posted

August 4, 2005

Study Start

June 1, 2004

Study Completion

April 1, 2005

Last Updated

August 19, 2005

Record last verified: 2005-08