Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne

Overview

Non-inferiority, randomized, controlled, multi-center, investigator-blind, parallel-group comparison study in subjects with severe acne vulgaris on the face.

Full Title of Study: “Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Associated With 200 mg Doxycycline Capsules Versus Vehicle Gel Associated With Isotretinoin Capsules in the Treatment of Severe Acne”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: July 2013

Interventions

  • Drug: Epiduo/Tactuo
    • topical to the face, once daily in the evening
  • Other: vehicle gel
    • topical to the face, once daily in the evening
  • Drug: doxycycline 200mg
    • oral, 2 capsules once daily in the morning with aglass of water and with food
  • Drug: Isotretinoin
    • oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.

Arms, Groups and Cohorts

  • Experimental: Epiduo/Tactuo + doxycycline 200mg
  • Active Comparator: Isotretinoin + vehicle gel

Clinical Trial Outcome Measures

Primary Measures

  • The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements
    • Time Frame: 20 weeks
    • Overall success is reached when the 2 following criteria are fulfilled : Overall efficacy: reduction of at least 75% of number of nodules at the end of treatment Safe treatment: Absence of any listed safety issues

Participating in This Clinical Trial

Inclusion Criteria

1. Male or female subject of any race, aged 12 to 35 years inclusive 2. Subject weighing between 50 and 110 kg 3. Subject with severe acne (IGA at least 4), which in the opinion of the investigator is appropriate for treatment with oral isotretinoin (severe nodular acne, severe inflammatory acne, recalcitrant acne; all unresponsive to conventional first line therapies) 4. Subject with at least 5 nodules on the face Exclusion Criteria:

1. Subject with clinically abnormal results to blood testings performed at screening 2. Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), pyoderma faciale, sinus tracks 3. Female subject who is pregnant, nursing or planning a pregnancy during the study 4. Subject with known history of hepatic and/or renal insufficiency, to be confirmed by blood testings 5. Subject with known metabolic or structural bone disease (for 12-17 years old population) 6. Subject with bowel disease and/or with hypervitaminosis A 7. Subject who presents with treated or untreated depression or has a history of depression including a family history of major depression 8. Subject with a wash-out period from baseline for topical treatment on the face less than : Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments (2 weeks); Cosmetic procedures (1 week); Photodynamic therapy and laser therapy for acne (3 months) 9. Subject with a wash-out period from baseline for systemic treatment less than: Corticosteroids, antibiotics (4 weeks),Progesterone for contraception (3 months); Spironolactone(3 months); Other acne treatments (6 months);Cyproterone acetate(6 months)

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Galderma R&D
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jerry Tan, Principal Investigator, Windsor Clinical Research Inc.

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