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Isotretinoin in Papular-Pustular Rosacea (ISOROS)

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. Identifier: NCT00882531
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : November 17, 2009
Quanta Medical
Information provided by:
Laboratoires Bailleul-Biorga

Brief 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.

Condition or disease Intervention/treatment Phase
Papular-pustular Rosacea Drug: isotretinoin Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : February 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: Isotretinoin Drug: isotretinoin
0.25 mg/kg, 1 per day, 4 month of treatment

Placebo Comparator: placebo Drug: placebo

Primary Outcome Measures :
  1. 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 :
  1. Improvement in patients' quality of life using the reduced Skindex-France QoL scale (30 items)
  2. Change in severity of other symptoms of rosacea (burning sensation, erythema, telangiectasia, vasomotor flush, etc)
  3. Patient satisfaction (on a visual analogue scale)
  4. Global treatment efficacy (global assessment)
  5. Relapse rates at 8 months (after start of treatment)
  6. Safety

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00882531

Sponsors and Collaborators
Laboratoires Bailleul-Biorga
Quanta Medical
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Principal Investigator: Olivier CHOSIDOW, Professor
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Responsible Party: Clara Jaramillo, laboratoires BAILLEUL BIORGA Identifier: NCT00882531    
Other Study ID Numbers: ISOROS
First Posted: April 16, 2009    Key Record Dates
Last Update Posted: November 17, 2009
Last Verified: November 2009
Additional relevant MeSH terms:
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Skin Diseases
Dermatologic Agents