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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01474590
First received: November 16, 2011
Last updated: November 22, 2013
Last verified: November 2013
  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 + doxycycline 200mg
Drug: Isotretinoin + vehicle gel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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: Efficacy: end of treatment & Safety: treatment phase ] [ Designated as safety issue: Yes ]

    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 + doxycycline 200mg
Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.
Active Comparator: Isotretinoin + vehicle gel Drug: Isotretinoin + vehicle gel
Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.

  Eligibility

Ages Eligible for Study:   12 Years to 35 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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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 -
  More Information

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01474590     History of Changes
Other Study ID Numbers: RD.03.SPR.29099
Study First Received: November 16, 2011
Last Updated: November 22, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Doxycycline
Isotretinoin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on August 25, 2014