MedTrace Logo

Isotretinoin in Papular-Pustular Rosacea

NCT00882531 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2009-11-17

No results posted yet for this study

Summary

A national, multicentre, prospective, randomised, double-blind, phase III study in 2 parallel groups of isotretinoin versus placebo in patients presenting papular-pustular rosacea resistant to standard therapy. A non-balanced group (2 isotretinoin /1 placebo) design was selected since, given the nature of the study disease, fewer patients will receive the placebo than active isotretinoin.

Treatment duration for each patient : 4 months, with monthly evaluation Follow-up at 2 months and 4 months for patients responsive after 4 months of treatment.

Conditions

  • Papular-pustular Rosacea

Interventions

DRUG

isotretinoin

0.25 mg/kg, 1 per day, 4 month of treatment

DRUG

placebo

Sponsors & Collaborators

  • Quanta Medical

    collaborator INDUSTRY

  • Laboratoires Bailleul-Biorga

    lead INDUSTRY

Principal Investigators

  • Olivier CHOSIDOW, Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2009-08-31
Completion
2009-09-30

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00882531 on ClinicalTrials.gov