Isotretinoin in Papular-Pustular Rosacea

NCT ID: NCT00882531

Last Updated: 2009-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2009-09-30

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.

Conditions

Papular-pustular Rosacea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Isotretinoin

Group Type: EXPERIMENTAL

isotretinoin

Intervention Type: DRUG

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

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

isotretinoin

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

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Quanta Medical

INDUSTRY

Sponsor Role: collaborator

Laboratoires Bailleul-Biorga

INDUSTRY

Sponsor Role: lead

Responsible Party

laboratoires BAILLEUL BIORGA

Principal Investigators

Olivier CHOSIDOW, Professor

Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ISOROS

Identifier Type: -

Identifier Source: org_study_id