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Trial record 13 of 233 for:    acne AND Percent

Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.

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ClinicalTrials.gov Identifier: NCT02073461
Recruitment Status : Completed
First Posted : February 27, 2014
Results First Posted : November 3, 2016
Last Update Posted : March 28, 2017
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: CD1579 2.5%
Drug: CD1579 5%
Drug: Vehicle
Enrollment 236
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CD1579 2.5% CD1579 5% Vehicle
Hide Arm/Group Description

Benzoyl Peroxide 2.5%

CD1579 2.5%

Benzoyl Peroxide 5%

CD1579 5%

Vehicle

Vehicle

Period Title: Overall Study
Started 79 78 79
Completed 75 77 78
Not Completed 4 1 1
Arm/Group Title CD1579 2.5% CD1579 5% Vehicle Total
Hide Arm/Group Description

Benzoyl Peroxide 2.5%

CD1579 2.5%

Benzoyl Peroxide 5%

CD1579 5%

Vehicle

Vehicle

Total of all reporting groups
Overall Number of Baseline Participants 79 78 79 236
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 79 participants 78 participants 79 participants 236 participants
22.1  (7.0) 21.1  (5.6) 21.0  (6.3) 21.4  (6.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 78 participants 79 participants 236 participants
Female
57
  72.2%
51
  65.4%
45
  57.0%
153
  64.8%
Male
22
  27.8%
27
  34.6%
34
  43.0%
83
  35.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 79 participants 78 participants 79 participants 236 participants
79 78 79 236
1.Primary Outcome
Title Percent Changes From Baseline in Total Lesion Counts
Hide Description Median percent reductions from Baseline in total lesion count (ITT-LOCF)
Time Frame Baseline - Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CD1579 2.5% CD1579 5% Vehicle
Hide Arm/Group Description:

Benzoyl Peroxide 2.5%

CD1579 2.5%

Benzoyl Peroxide 5%

CD1579 5%

Vehicle

Vehicle

Overall Number of Participants Analyzed 79 78 78
Median (Full Range)
Unit of Measure: percent change
58.3
(-243.7 to 100)
65.9
(-41.0 to 100)
25.5
(-180.7 to 88.9)
2.Secondary Outcome
Title Percent of Subjects With Adverse Events
Hide Description Adverse events which were observed in 5% or more patients with either group are listed.
Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CD1579 2.5% CD1579 5% Vehicle
Hide Arm/Group Description:

Benzoyl Peroxide 2.5%

CD1579 2.5%

Benzoyl Peroxide 5%

CD1579 5%

Vehicle

Vehicle

Overall Number of Participants Analyzed 79 78 79
Measure Type: Number
Unit of Measure: percentage of participants
% of subjects with AEs 43.0 39.7 32.9
Nasopharyngitis 12.7 14.1 13.9
Headache 10.1 1.3 8.9
Dysmenorrhea 6.3 3.8 3.8
3.Secondary Outcome
Title Local Tolerability (Erythema)
Hide Description Highest severity of local tolerability scores worse than Baseline
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CD1579 2.5% CD1579 5% Vehicle
Hide Arm/Group Description:

Benzoyl Peroxide 2.5%

CD1579 2.5%

Benzoyl Peroxide 5%

CD1579 5%

Vehicle

Vehicle

Overall Number of Participants Analyzed 79 78 79
Measure Type: Number
Unit of Measure: participants
Mild 12 18 5
Moderate 3 3 0
Severe 0 1 0
4.Secondary Outcome
Title Local Tolerability (Scaling)
Hide Description Highest severity of local tolerability scores worse than Baseline
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CD1579 2.5% CD1579 5% Vehicle
Hide Arm/Group Description:

Benzoyl Peroxide 2.5%

CD1579 2.5%

Benzoyl Peroxide 5%

CD1579 5%

Vehicle

Vehicle

Overall Number of Participants Analyzed 79 78 79
Measure Type: Number
Unit of Measure: participants
Mild 15 25 8
Moderate 4 7 1
5.Secondary Outcome
Title Local Tolerability (Dryness)
Hide Description Highest severity of local tolerability scores worse than Baseline
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CD1579 2.5% CD1579 5% Vehicle
Hide Arm/Group Description:

Benzoyl Peroxide 2.5%

CD1579 2.5%

Benzoyl Peroxide 5%

CD1579 5%

Vehicle

Vehicle

Overall Number of Participants Analyzed 79 78 79
Measure Type: Number
Unit of Measure: participants
Mild 20 33 10
Moderate 2 6 0
6.Secondary Outcome
Title Local Tolerability (Pruritus)
Hide Description Highest severity of local tolerability scores worse than Baseline
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CD1579 2.5% CD1579 5% Vehicle
Hide Arm/Group Description:

Benzoyl Peroxide 2.5%

CD1579 2.5%

Benzoyl Peroxide 5%

CD1579 5%

Vehicle

Vehicle

Overall Number of Participants Analyzed 79 78 79
Measure Type: Number
Unit of Measure: participants
Mild 20 13 6
Moderate 6 7 1
Severe 1 2 0
7.Secondary Outcome
Title Local Tolerability (Stinging/Burning)
Hide Description Highest severity of local tolerability scores worse than Baseline
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CD1579 2.5% CD1579 5% Vehicle
Hide Arm/Group Description:

Benzoyl Peroxide 2.5%

CD1579 2.5%

Benzoyl Peroxide 5%

CD1579 5%

Vehicle

Vehicle

Overall Number of Participants Analyzed 79 78 79
Measure Type: Number
Unit of Measure: participants
Mild 19 29 4
Moderate 6 7 1
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CD1579 2.5% CD1579 5% Vehicle
Hide Arm/Group Description

Benzoyl Peroxide 2.5%

CD1579 2.5%

Benzoyl Peroxide 5%

CD1579 5%

Vehicle

Vehicle

All-Cause Mortality
CD1579 2.5% CD1579 5% Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CD1579 2.5% CD1579 5% Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/79 (0.00%)      0/78 (0.00%)      1/79 (1.27%)    
Injury, poisoning and procedural complications       
Compression fracture  0/79 (0.00%)  0/78 (0.00%)  1/79 (1.27%) 
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
CD1579 2.5% CD1579 5% Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/79 (43.04%)      31/78 (39.74%)      26/79 (32.91%)    
Ear and labyrinth disorders       
Ear pruritus  1/79 (1.27%)  1 0/78 (0.00%)  0 0/79 (0.00%)  0
Eye disorders       
Erythema of eyelid  1/79 (1.27%)  1 1/78 (1.28%)  1 0/79 (0.00%)  0
Conjunctivitis allergic  0/79 (0.00%)  0 0/78 (0.00%)  0 1/79 (1.27%)  1
Gastrointestinal disorders       
Abdominal pain  0/79 (0.00%)  0 1/78 (1.28%)  1 1/79 (1.27%)  1
Abdominal pain upper  0/79 (0.00%)  0 1/78 (1.28%)  1 0/79 (0.00%)  0
Diarrhoea  0/79 (0.00%)  0 1/78 (1.28%)  1 0/79 (0.00%)  0
Toothache  0/79 (0.00%)  0 0/78 (0.00%)  0 1/79 (1.27%)  2
Vomiting  0/79 (0.00%)  0 1/78 (1.28%)  1 0/79 (0.00%)  0
General disorders       
Vessel puncture site haematoma 1 [1]  0/79 (0.00%)  0 1/78 (1.28%)  1 0/79 (0.00%)  0
Hepatobiliary disorders       
Hyperbilirubinaemia  0/79 (0.00%)  0 1/78 (1.28%)  1 0/79 (0.00%)  0
Immune system disorders       
Seasonal allergy  2/79 (2.53%)  2 2/78 (2.56%)  2 2/79 (2.53%)  2
Allergy to arthropod sting  0/79 (0.00%)  0 0/78 (0.00%)  0 1/79 (1.27%)  1
Infections and infestations       
Nasopharyngitis  10/79 (12.66%)  11 11/78 (14.10%)  12 11/79 (13.92%)  12
Oral herpes  1/79 (1.27%)  1 2/78 (2.56%)  2 0/79 (0.00%)  0
Otitis externa  1/79 (1.27%)  1 0/78 (0.00%)  0 0/79 (0.00%)  0
Tinea pedis  1/79 (1.27%)  1 1/78 (1.28%)  1 0/79 (0.00%)  0
Acute tonsillitis  0/79 (0.00%)  0 1/78 (1.28%)  1 0/79 (0.00%)  0
Herpes simplex  0/79 (0.00%)  0 0/78 (0.00%)  0 1/79 (1.27%)  1
Influenza  0/79 (0.00%)  0 1/78 (1.28%)  1 0/79 (0.00%)  0
Laryngitis  0/79 (0.00%)  0 1/78 (1.28%)  1 0/79 (0.00%)  0
Pharyngitis  0/79 (0.00%)  0 1/78 (1.28%)  1 0/79 (0.00%)  0
Tinea versicolour  0/79 (0.00%)  0 0/78 (0.00%)  0 1/79 (1.27%)  1
Injury, poisoning and procedural complications       
Contusion  1/79 (1.27%)  1 0/78 (0.00%)  0 0/79 (0.00%)  0
Excoriation  1/79 (1.27%)  1 0/78 (0.00%)  0 1/79 (1.27%)  1
Hand fracture  1/79 (1.27%)  1 0/78 (0.00%)  0 0/79 (0.00%)  0
Ligament sprain  1/79 (1.27%)  1 0/78 (0.00%)  0 0/79 (0.00%)  0
Post-traumatic neck syndrome  1/79 (1.27%)  1 0/78 (0.00%)  0 0/79 (0.00%)  0
Radius fracture  1/79 (1.27%)  1 0/78 (0.00%)  0 0/79 (0.00%)  0
Arthropod bite  0/79 (0.00%)  0 0/78 (0.00%)  0 1/79 (1.27%)  1
Thermal burn  0/79 (0.00%)  0 1/78 (1.28%)  1 0/79 (0.00%)  0
Investigations       
Protein urine present  1/79 (1.27%)  1 0/78 (0.00%)  0 0/79 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain  0/79 (0.00%)  0 1/78 (1.28%)  1 0/79 (0.00%)  0
Synovial cyst  0/79 (0.00%)  0 1/78 (1.28%)  1 0/79 (0.00%)  0
Nervous system disorders       
Headache  8/79 (10.13%)  11 1/78 (1.28%)  7 7/79 (8.86%)  13
Reproductive system and breast disorders       
Dysmenorrhoea  5/79 (6.33%)  8 3/78 (3.85%)  4 3/79 (3.80%)  4
Premenstrual syndrome  0/79 (0.00%)  0 1/78 (1.28%)  1 0/79 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Rhinitis allergic  2/79 (2.53%)  2 0/78 (0.00%)  0 0/79 (0.00%)  0
Upper respiratory tract inflammation  0/79 (0.00%)  0 1/78 (1.28%)  1 0/79 (0.00%)  0
Skin and subcutaneous tissue disorders       
Skin irritation  3/79 (3.80%)  3 1/78 (1.28%)  1 0/79 (0.00%)  0
Drug eruption  1/79 (1.27%)  1 0/78 (0.00%)  0 0/79 (0.00%)  0
Eczema  1/79 (1.27%)  1 2/78 (2.56%)  2 0/79 (0.00%)  0
Urticaria  1/79 (1.27%)  1 2/78 (2.56%)  2 0/79 (0.00%)  0
Dermatitis allergic  0/79 (0.00%)  0 1/78 (1.28%)  1 0/79 (0.00%)  0
Dermatitis contact  0/79 (0.00%)  0 0/78 (0.00%)  0 1/79 (1.27%)  1
Dry skin  0/79 (0.00%)  0 1/78 (1.28%)  1 0/79 (0.00%)  0
Eczema asteatotic  0/79 (0.00%)  0 1/78 (1.28%)  1 0/79 (0.00%)  0
Urticaria chronic  0/79 (0.00%)  0 1/78 (1.28%)  1 0/79 (0.00%)  0
1
Term from vocabulary, MedDRA 15.0
[1]
General disorders and administration site conditions
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
Name/Title: Clinical Project Manager
Organization: Galderma K.K.
Phone: +81 3 5937 3850
Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT02073461     History of Changes
Other Study ID Numbers: RDT.07.SPR.27124
First Submitted: February 20, 2014
First Posted: February 27, 2014
Results First Submitted: September 15, 2016
Results First Posted: November 3, 2016
Last Update Posted: March 28, 2017