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Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT01880320
Recruitment Status : Completed
First Posted : June 18, 2013
Results First Posted : September 9, 2016
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: CD0271 0.3% / CD1579 2.5%
Drug: CD0271 0.1% / CD1579 2.5%
Drug: Topical Gel Vehicle
Enrollment 503
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CD0271 0.3% /CD1579 2.5% Gel CD0271 0.1% / CD1579 2.5% Topical Gel Vehicle
Hide Arm/Group Description

Active arm

CD0271 0.3% / CD1579 2.5%

Comparator arm

CD0271 0.1% / CD1579 2.5%

Placebo arm

Topical Gel Vehicle

Period Title: Overall Study
Started 217 217 69
Completed 197 192 61
Not Completed 20 25 8
Arm/Group Title CD0271 0.3% /CD1579 2.5% Gel CD0271 0.1% / CD1579 2.5% Topical Gel Vehicle Total
Hide Arm/Group Description

Active arm

CD0271 0.3% / CD1579 2.5%

Comparator arm

CD0271 0.1% / CD1579 2.5%

Placebo arm

Topical Gel Vehicle

Total of all reporting groups
Overall Number of Baseline Participants 217 217 69 503
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 217 participants 217 participants 69 participants 503 participants
<=18 years
124
  57.1%
136
  62.7%
43
  62.3%
303
  60.2%
Between 18 and 65 years
93
  42.9%
81
  37.3%
26
  37.7%
200
  39.8%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 217 participants 217 participants 69 participants 503 participants
20.1  (7.59) 19.4  (6.75) 18.5  (5.72) 19.6  (7.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 217 participants 217 participants 69 participants 503 participants
Female
113
  52.1%
114
  52.5%
36
  52.2%
263
  52.3%
Male
104
  47.9%
103
  47.5%
33
  47.8%
240
  47.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 217 participants 217 participants 69 participants 503 participants
Canada 17 16 5 38
United States 200 201 64 465
Baseline Investigator Global Assessment (IGA)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 217 participants 217 participants 69 participants 503 participants
Baseline IGA = Moderate (3) 111 105 35 251
Baseline IGA = Severe (4) 106 112 34 252
1.Primary Outcome
Title Success Rate
Hide Description

Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA).

Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): All subjects who were randomized. Baseline IGA Severe population: All randomized subjects who had IGA=4 at baseline.
Arm/Group Title CD0271 0.3% /CD1579 2.5% Gel CD0271 0.1% / CD1579 2.5% Topical Gel Vehicle
Hide Arm/Group Description:

Active arm

CD0271 0.3% / CD1579 2.5%

Comparator arm

CD0271 0.1% / CD1579 2.5%

Placebo arm

Topical Gel Vehicle

Overall Number of Participants Analyzed 217 217 69
Measure Type: Number
Unit of Measure: percentage of participants
All subjects (MI: Multiple Imputation) Number Analyzed 217 participants 217 participants 69 participants
33.7 27.3 11.0
Baseline IGA=Severe (4) (MI: Multiple Imputation) Number Analyzed 106 participants 112 participants 34 participants
31.9 20.5 11.8
2.Primary Outcome
Title Changes From Baseline in Inflammatory Lesion Counts
Hide Description [Not Specified]
Time Frame Baseline - Week12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, Multiple imputation
Arm/Group Title CD0271 0.3% /CD1579 2.5% Gel CD0271 0.1% / CD1579 2.5% Topical Gel Vehicle
Hide Arm/Group Description:

Active arm

CD0271 0.3% / CD1579 2.5%

Comparator arm

CD0271 0.1% / CD1579 2.5%

Placebo arm

Topical Gel Vehicle

Overall Number of Participants Analyzed 217 217 69
Least Squares Mean (Standard Error)
Unit of Measure: Lesions
All Subjects Number Analyzed 217 participants 217 participants 69 participants
-27.04  (0.846) -26.72  (0.822) -14.40  (1.460)
Baseline IGA = Severe (4) Number Analyzed 106 participants 112 participants 34 participants
-35.17  (1.407) -31.92  (1.320) -15.46  (2.297)
3.Primary Outcome
Title Changes From Baseline in Non-Inflammatory Lesion Counts
Hide Description [Not Specified]
Time Frame Baseline - Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population, Multiple Imputation
Arm/Group Title CD0271 0.3% /CD1579 2.5% Gel CD0271 0.1% / CD1579 2.5% Topical Gel Vehicle
Hide Arm/Group Description:

Active arm

CD0271 0.3% / CD1579 2.5%

Comparator arm

CD0271 0.1% / CD1579 2.5%

Placebo arm

Topical Gel Vehicle

Overall Number of Participants Analyzed 217 217 69
Least Squares Mean (Standard Error)
Unit of Measure: lesions
All Subjects Number Analyzed 217 participants 217 participants 69 participants
-40.18  (1.332) -39.00  (1.277) -18.47  (2.270)
Baseline IGA = Severe (4) Number Analyzed 106 participants 112 participants 34 participants
-45.61  (2.058) -43.10  (1.847) -17.25  (3.337)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CD0271 0.3% /CD1579 2.5% Gel CD0271 0.1% / CD1579 2.5% Topical Gel Vehicle
Hide Arm/Group Description

Active arm

CD0271 0.3% / CD1579 2.5%

Comparator arm

CD0271 0.1% / CD1579 2.5%

Placebo arm

Topical Gel Vehicle

All-Cause Mortality
CD0271 0.3% /CD1579 2.5% Gel CD0271 0.1% / CD1579 2.5% Topical Gel Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CD0271 0.3% /CD1579 2.5% Gel CD0271 0.1% / CD1579 2.5% Topical Gel Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/217 (0.00%)      1/217 (0.46%)      0/69 (0.00%)    
Psychiatric disorders       
Generalized Anxiety Disorder  0/217 (0.00%)  0 1/217 (0.46%)  1 0/69 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
CD0271 0.3% /CD1579 2.5% Gel CD0271 0.1% / CD1579 2.5% Topical Gel Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/217 (15.67%)      23/217 (10.60%)      13/69 (18.84%)    
Ear and labyrinth disorders       
Motion sickness  0/217 (0.00%)  0/217 (0.00%)  1/69 (1.45%) 
General disorders       
Fatigue  0/217 (0.00%)  1/217 (0.46%)  1/69 (1.45%) 
Pyrexia  0/217 (0.00%)  0/217 (0.00%)  1/69 (1.45%) 
Infections and infestations       
Nasopharyngitis  14/217 (6.45%)  11/217 (5.07%)  1/69 (1.45%) 
Upper respiratory tract infection  1/217 (0.46%)  5/217 (2.30%)  4/69 (5.80%) 
Infleunza  2/217 (0.92%)  2/217 (0.92%)  1/69 (1.45%) 
Gastroenteritis  3/217 (1.38%)  1/217 (0.46%)  0/69 (0.00%) 
Ear infection  0/217 (0.00%)  0/217 (0.00%)  1/69 (1.45%) 
Pharyngitis  0/217 (0.00%)  0/217 (0.00%)  1/69 (1.45%) 
Metabolism and nutrition disorders       
Hypokalemia  0/217 (0.00%)  0/217 (0.00%)  1/69 (1.45%) 
Nervous system disorders       
Headache  3/217 (1.38%)  2/217 (0.92%)  1/69 (1.45%) 
Dizziness  0/217 (0.00%)  0/217 (0.00%)  1/69 (1.45%) 
Rhinitis seasonal  0/217 (0.00%)  0/217 (0.00%)  1/69 (1.45%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1/217 (0.46%)  1/217 (0.46%)  1/69 (1.45%) 
Skin and subcutaneous tissue disorders       
Skin irritation  9/217 (4.15%)  1/217 (0.46%)  0/69 (0.00%) 
Dermatitis allergic  1/217 (0.46%)  3/217 (1.38%)  0/69 (0.00%) 
Eczema  3/217 (1.38%)  0/217 (0.00%)  0/69 (0.00%) 
Rash  1/217 (0.46%)  0/217 (0.00%)  1/69 (1.45%) 
Urticaria  1/217 (0.46%)  0/217 (0.00%)  1/69 (1.45%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Galderma CPM
Organization: Galderma R&D
Phone: 00 33 4 93 95 70 70
EMail: clinicaltrials@galderma.com
Layout table for additonal information
Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01880320     History of Changes
Other Study ID Numbers: RD.06.SPR.18240
First Submitted: June 14, 2013
First Posted: June 18, 2013
Results First Submitted: March 7, 2016
Results First Posted: September 9, 2016
Last Update Posted: June 28, 2018