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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01474590
First Posted: November 18, 2011
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Galderma
November 16, 2011
November 18, 2011
January 17, 2017
August 28, 2017
August 28, 2017
November 2011
July 2013   (Final data collection date for primary outcome measure)
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 :

  1. Overall efficacy: reduction of at least 75% of number of nodules at the end of treatment
  2. Safe treatment: Absence of any listed safety issues
The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements [ Time Frame: Efficacy: end of treatment & Safety: treatment phase ]

Overall success is reached when the 2 following criteria are fulfilled :

  1. Overall efficacy: reduction of at least 75% of number of nodules at the end of treatment
  2. Safe treatment: Absence of any listed safety issues
Complete list of historical versions of study NCT01474590 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne
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
Non-inferiority, randomized, controlled, multi-center, investigator-blind, parallel-group comparison study in subjects with severe acne vulgaris on the face.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Acne
  • 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.
  • Experimental: Epiduo/Tactuo + doxycycline 200mg
    Interventions:
    • Drug: Epiduo/Tactuo
    • Drug: doxycycline 200mg
  • Active Comparator: Isotretinoin + vehicle gel
    Interventions:
    • Other: vehicle gel
    • Drug: Isotretinoin
Tan J, Humphrey S, Vender R, Barankin B, Gooderham M, Kerrouche N, Audibert F, Lynde C; POWER study group. A treatment for severe nodular acne: a randomized investigator-blinded, controlled, noninferiority trial comparing fixed-dose adapalene/benzoyl peroxide plus doxycycline vs. oral isotretinoin. Br J Dermatol. 2014 Dec;171(6):1508-16. doi: 10.1111/bjd.13191. Epub 2014 Oct 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
266
August 2013
July 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
12 Years to 35 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01474590
RD.03.SPR.29099
No
Not Provided
Not Provided
Galderma
Galderma
Not Provided
Principal Investigator: Jerry Tan Windsor Clinical Research Inc.
Galderma
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP