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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
Results First Submitted: January 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition: Acne
Interventions: Drug: Epiduo/Tactuo
Other: vehicle gel
Drug: doxycycline 200mg
Drug: Isotretinoin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Epiduo/Tactuo + Doxycycline 200mg 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.
Isotretinoin + Vehicle Gel 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.

Participant Flow:   Overall Study
    Epiduo/Tactuo + Doxycycline 200mg   Isotretinoin + Vehicle Gel
STARTED   133   133 
COMPLETED   105   116 
NOT COMPLETED   28   17 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Epiduo/Tactuo + Doxycycline 200mg 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.
Isotretinoin + Vehicle Gel 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.
Total Total of all reporting groups

Baseline Measures
   Epiduo/Tactuo + Doxycycline 200mg   Isotretinoin + Vehicle Gel   Total 
Overall Participants Analyzed 
[Units: Participants]
 133   133   266 
Age 
[Units: Years]
Mean (Standard Deviation)
 19.5  (5.0)   19.3  (4.5)   19.4  (4.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      18  13.5%      21  15.8%      39  14.7% 
Male      115  86.5%      112  84.2%      227  85.3% 
Region of Enrollment 
[Units: Count of participants]
     
Canada   133   133   266 
IGA [1] 
[Units: Count of participants]
     
 118   115   233 
 15   18   33 
[1]

the global severity assessment is outlined as per below:

Investigator’s Global Assessment (IGA)

score

0. Clear: Residual hyperpigmentation and erythema may be present

  1. Almost Clear A few scattered comedones and a few small papules
  2. Mild Some comedones and some papules and pustules. No nodules present
  3. Moderate Many comedones, papules and pustules. One nodule may be present
  4. Severe Covered with comedones, numerous papules and pustules and few nodules may be present
  5. Very severe Highly inflammatory acne covering the face; with nodules present
nodule counts 
[Units: Nodules]
Mean (Standard Deviation)
 8.0  (3.6)   7.6  (2.5)   7.8  (3.1) 


  Outcome Measures

1.  Primary:   The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements   [ Time Frame: 20 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Jerry Tan
Organization: University of Western Ontario and Windsor Clinical Research Inc., 2224 Walker Rd. Suite 300, Windsor, ON, Canada
e-mail: jerrytan@bellnet.ca


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