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

February 16, 2021 updated by: Galderma R&D

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

266

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • 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
        • Galderma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Investigators

  • Principal Investigator: Jerry Tan, Windsor Clinical Research Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

November 16, 2011

First Submitted That Met QC Criteria

November 17, 2011

First Posted (Estimate)

November 18, 2011

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.03.SPR.29099

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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