Trial | NCT00882531  Report issue

Title

Isotretinoin in Papular-Pustular Rosacea
Evaluation of the Efficacy of Isotretinoin Versus Placebo in Terms of Response Rate Among Patients Presenting Papular-pustular Rosacea Resistant to Standard Therapy

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    isotretinoin ...

  • Study Participants

    156
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.
Study Started
Feb 28
2007
Primary Completion
Aug 31
2009
Study Completion
Sep 30
2009
Last Update
Nov 17
2009
Estimate

Drug isotretinoin

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

Drug placebo

Isotretinoin Experimental

placebo Placebo Comparator

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
No Results Posted