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

Condition Intervention Phase
Acne Drug: Epiduo/Tactuo Other: vehicle gel Drug: doxycycline 200mg Drug: Isotretinoin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome 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 :

    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


Enrollment: 266
Study Start Date: November 2011
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epiduo/Tactuo + doxycycline 200mg Drug: Epiduo/Tactuo
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
Active Comparator: Isotretinoin + vehicle gel Other: vehicle gel
topical to the face, once daily in the evening
Drug: Isotretinoin
oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474590


Locations
Canada
Galderma investigational site
Ajax, Canada
Galderma investigational site
Barrie, Canada
Galderma investigational site
Calgary, Canada
Galderma investigational site
Edmonton, Canada
Galderma investigational site
Halifax, Canada
Galderma investigational site
Hamilton, Canada
Galderma investigational site
Markham, Canada
Galderma investigational site
Montreal, Canada
Galderma investigational site
Newmarket, Canada
Galderma investigational site
Oakville, Canada
Galderma investigational site
Oshawa, Canada
Galderma investigational site
Peterborough, Canada
Galderma investigational site
Quebec city, Canada
Galderma investigational site
Richmond Hill, Canada
Galderma investigational site
Saint-Hyacinthe, Canada
Galderma investigational site
Saint-John's, Canada
Galderma investigational site
Saskatoon, Canada
Galderma investigational site
St John's, Canada
Galderma investigational site
Sudbury, Canada
Galderma investigational site
Surrey, Canada
Galderma investigational site
Toronto, Canada
Galderma investigational site
Vancouver, Canada
Galderma investigational site
Waterloo, Canada
Galderma investigational site
Windsor, Canada
Galderma investigational site
Winnipeg, Canada
Galderma investigational site
Woodbridge, Canada
Sponsors and Collaborators
Galderma
Investigators
Principal Investigator: Jerry Tan Windsor Clinical Research Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01474590     History of Changes
Other Study ID Numbers: RD.03.SPR.29099
First Submitted: November 16, 2011
First Posted: November 18, 2011
Results First Submitted: January 17, 2017
Results First Posted: August 28, 2017
Last Update Posted: August 28, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Doxycycline
Isotretinoin
Adapalene, Benzoyl Peroxide Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents