Text Size

Isotretinoin in Papular-Pustular Rosacea (ISOROS)

This study has been completed.
Sponsor:
Collaborator:
Quanta Medical
Information provided by:
Laboratoires Bailleul-Biorga
ClinicalTrials.gov Identifier:
NCT00882531
First received: April 15, 2009
Last updated: November 16, 2009
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Papular-pustular Rosacea
 Drug: isotretinoin
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Isotretinoin Versus Placebo in Terms of Response Rate Among Patients Presenting Papular-pustular Rosacea Resistant to Standard Therapy

Resource links provided by NLM:

MedlinePlus related topics: Rosacea
U.S. FDA Resources

Further study details as provided by Laboratoires Bailleul-Biorga:

Primary Outcome Measures:
  • To determine numbers of patients responding to treatment for 4 months with isotretinoin (patients were considered as responders if their number of papular-pustular lesions fell by at least 90% after 4 months of treatment)

Secondary Outcome Measures:
  • Improvement in patients' quality of life using the reduced Skindex-France QoL scale (30 items)
  • Change in severity of other symptoms of rosacea (burning sensation, erythema, telangiectasia, vasomotor flush, etc)
  • Patient satisfaction (on a visual analogue scale)
  • Global treatment efficacy (global assessment)
  • Relapse rates at 8 months (after start of treatment)
  • Safety

Enrollment: 156
Study Start Date: February 2007
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Isotretinoin Drug: isotretinoin
0.25 mg/kg, 1 per day, 4 month of treatment
Placebo Comparator: placebo Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult
  • Patients presenting papular-pustular rosacea (characterised by at least 8 lesions (papules and/or pustules)
  • resistant for at least 3 months in the last two years to standard treatment comprising systemic antibiotics (cyclins) with or without topical therapy
  • Full compliance with a two-week wash-out period for all other topical and systemic treatments for rosacea at the time of selection
  • For women of childbearing age, use of a minimum of one "effective" contraceptive method for at least one month and willingness to continue using an effective contraceptive method continuously throughout the study duration and for at least one month after the end of treatment.
  • Women of childbearing age must provide consent for pregnancy testing before the start of treatment, monthly throughout treatment and 5 weeks after the end of treatment.
  • Negative pregnancy test results from within the last 3 days (for female subjects of childbearing age)
  • No laboratory abnormalities in standard tests
  • Social Security medical cover
  • Provision of written and dated informed consent to take part in the study

Exclusion Criteria:

  • Patients already receiving isotretinoin for rosacea or within the last 12 months for acne
  • Patients presenting perioral dermatitis
  • Patients presenting miliary lupoid
  • Patients presenting cortisone-induced rosacea
  • Pregnant or breast-feeding women
  • Patients with repeated and habitual heavy physical activity
  • Patients with known hepatic impairment presenting cytolysis as attested by laboratory results
  • Patients presenting hyperaemia
  • Patient presenting hypervitaminosis A
  • Patients with a history of hypersensitivity to isotretinoin
  • Patients with allergy to soy oil
  • Patients on tetracycline
  • Patients with depression treated at the time of selection
  • Patients currently taking part in having taken part in another study in the last 3 months prior to inclusion in the present study
  • Patients protected by law (under guardianship or trusteeship)
  • Patients unable to comply with the study requirements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882531

Sponsors and Collaborators
Laboratoires Bailleul-Biorga
Quanta Medical
Investigators
Principal Investigator: Olivier CHOSIDOW, Professor
  More Information

No publications provided

Responsible Party: Clara Jaramillo, laboratoires BAILLEUL BIORGA
ClinicalTrials.gov Identifier: NCT00882531     History of Changes
Other Study ID Numbers: ISOROS
Study First Received: April 15, 2009
Last Updated: November 16, 2009
Health Authority: France: Institutional Ethical Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Isotretinoin
 Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013