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Isotretinoin in Papular-Pustular Rosacea (ISOROS)

Primary Purpose

Papular-pustular Rosacea

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
isotretinoin
placebo
Sponsored by
Laboratoires Bailleul-Biorga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Papular-pustular Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Isotretinoin

    placebo

    Arm Description

    Outcomes

    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

    Full Information

    First Posted
    April 15, 2009
    Last Updated
    November 16, 2009
    Sponsor
    Laboratoires Bailleul-Biorga
    Collaborators
    Quanta Medical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00882531
    Brief Title
    Isotretinoin in Papular-Pustular Rosacea
    Acronym
    ISOROS
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2007 (undefined)
    Primary Completion Date
    August 2009 (Actual)
    Study Completion Date
    September 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Laboratoires Bailleul-Biorga
    Collaborators
    Quanta Medical

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Papular-pustular Rosacea

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    156 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Isotretinoin
    Arm Type
    Experimental
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    isotretinoin
    Intervention Description
    0.25 mg/kg, 1 per day, 4 month of treatment
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Improvement in patients' quality of life using the reduced Skindex-France QoL scale (30 items)
    Title
    Change in severity of other symptoms of rosacea (burning sensation, erythema, telangiectasia, vasomotor flush, etc)
    Title
    Patient satisfaction (on a visual analogue scale)
    Title
    Global treatment efficacy (global assessment)
    Title
    Relapse rates at 8 months (after start of treatment)
    Title
    Safety

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Olivier CHOSIDOW, Professor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Isotretinoin in Papular-Pustular Rosacea

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