Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 98 of 134 for:    acne AND peroxide

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

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.
 
ClinicalTrials.gov Identifier: NCT01474590
Recruitment Status : Completed
First Posted : November 18, 2011
Results First Posted : August 28, 2017
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
Galderma

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
Enrollment 266
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Epiduo/Tactuo + Doxycycline 200mg Isotretinoin + Vehicle Gel
Hide Arm/Group Description 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: 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.
Period Title: Overall Study
Started 133 133
Completed 105 116
Not Completed 28 17
Arm/Group Title Epiduo/Tactuo + Doxycycline 200mg Isotretinoin + Vehicle Gel Total
Hide Arm/Group Description 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: 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 of all reporting groups
Overall Number of Baseline Participants 133 133 266
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 133 participants 133 participants 266 participants
19.5  (5.0) 19.3  (4.5) 19.4  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 133 participants 266 participants
Female
18
  13.5%
21
  15.8%
39
  14.7%
Male
115
  86.5%
112
  84.2%
227
  85.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Count of participants
Canada Number Analyzed 133 participants 133 participants 266 participants
133 133 266
IGA   [1] 
Measure Type: Number
Unit of measure:  Count of participants
Number Analyzed 133 participants 133 participants 266 participants
4 118 115 233
5 15 18 33
[1]
Measure Description:

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  
Mean (Standard Deviation)
Unit of measure:  Nodules
Number Analyzed 133 participants 133 participants 266 participants
8.0  (3.6) 7.6  (2.5) 7.8  (3.1)
1.Primary Outcome
Title The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements
Hide Description

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
Time Frame 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Epiduo/Tactuo + Doxycycline 200mg Isotretinoin + Vehicle Gel
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 133 133
Measure Type: Number
Unit of Measure: count of participants
85 73
Time Frame 20 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Epiduo/Tactuo + Doxycycline 200mg Isotretinoin + Vehicle Gel
Hide Arm/Group Description 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: 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.
All-Cause Mortality
Epiduo/Tactuo + Doxycycline 200mg Isotretinoin + Vehicle Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Epiduo/Tactuo + Doxycycline 200mg Isotretinoin + Vehicle Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/133 (0.00%)      1/133 (0.75%)    
Skin and subcutaneous tissue disorders     
Stevens–Johnson syndrome  1  0/133 (0.00%)  0 1/133 (0.75%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Epiduo/Tactuo + Doxycycline 200mg Isotretinoin + Vehicle Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/133 (18.80%)      66/133 (49.62%)    
Gastrointestinal disorders     
lip dry  1  9/133 (6.77%)  9 66/133 (49.62%)  72
nausea  1  14/133 (10.53%)  14 5/133 (3.76%)  5
vomiting  1  12/133 (9.02%)  14 2/133 (1.50%)  2
cheilitis  1  2/133 (1.50%)  2 32/133 (24.06%)  33
Infections and infestations     
naospharyngitis  1  15/133 (11.28%)  17 14/133 (10.53%)  17
UPTRI (Upper Tract Respiratory Infection)  1  9/133 (6.77%)  10 13/133 (9.77%)  16
Nervous system disorders     
headache  1  12/133 (9.02%)  14 11/133 (8.27%)  12
Skin and subcutaneous tissue disorders     
dry skin  1  25/133 (18.80%)  31 43/133 (32.33%)  56
skin irritation  1  14/133 (10.53%)  17 7/133 (5.26%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jerry Tan
Organization: University of Western Ontario and Windsor Clinical Research Inc., 2224 Walker Rd. Suite 300, Windsor, ON, Canada
EMail: jerrytan@bellnet.ca
Layout table for additonal information
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