Isotretinoin in Papular-Pustular Rosacea (ISOROS)

Laboratoires Bailleul

Status and phase

Completed

Phase 3

Conditions

Papular-pustular Rosacea

Treatments

Drug: placebo

Drug: isotretinoin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00882531

ISOROS

Details and patient eligibility

About

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.

Enrollment

156 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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