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Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.

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ClinicalTrials.gov Identifier: NCT02073448
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: GK530G
Drug: CD0271
Drug: CD1579
Enrollment 417
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CD0271 GK530G CD1579
Hide Arm/Group Description

Adapalene 01% Gel

CD0271

Fixed-dose combination gel of Adapalene and Benzoyl Peroxide

GK530G

Benzoyl Peroxide 2.5% Gel

CD1579

Period Title: Overall Study
Started 101 212 104
Completed 99 200 99
Not Completed 2 12 5
Arm/Group Title GK530G CD0271 CD1579 Total
Hide Arm/Group Description

Fixed-dose combination gel of Adapalene and Benzoyl Peroxide

GK530G

Adapalene 01% Gel

CD0271

Benzoyl Peroxide 2.5% Gel

CD1579

Total of all reporting groups
Overall Number of Baseline Participants 212 101 104 417
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 212 participants 101 participants 104 participants 417 participants
<=18 years
116
  54.7%
56
  55.4%
56
  53.8%
228
  54.7%
Between 18 and 65 years
96
  45.3%
45
  44.6%
48
  46.2%
189
  45.3%
>=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 212 participants 101 participants 104 participants 417 participants
19.7  (6.5) 19.6  (6.0) 19.3  (5.4) 19.6  (6.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 212 participants 101 participants 104 participants 417 participants
Female
141
  66.5%
67
  66.3%
74
  71.2%
282
  67.6%
Male
71
  33.5%
34
  33.7%
30
  28.8%
135
  32.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 212 participants 101 participants 104 participants 417 participants
212 101 104 417
1.Primary Outcome
Title Percent Changes From Baseline in Total Lesion Counts
Hide Description [Not Specified]
Time Frame Baseline - Week12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CD0271 GK530G CD1579
Hide Arm/Group Description:

Adapalene 01% Gel

CD0271

Fixed-dose combination gel of Adapalene and Benzoyl Peroxide

GK530G

Benzoyl Peroxide 2.5% Gel

CD1579

Overall Number of Participants Analyzed 101 212 104
Median (Full Range)
Unit of Measure: percent change
68.6
(-62.4 to 97.5)
82.7
(-15.9 to 100)
81.6
(-31.6 to 98.6)
2.Secondary Outcome
Title Percent of Subjects With Adverse Events
Hide Description [Not Specified]
Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CD0271 GK530G CD1579
Hide Arm/Group Description:

Adapalene 01% Gel

CD0271

Fixed-dose combination gel of Adapalene and Benzoyl Peroxide

GK530G

Benzoyl Peroxide 2.5% Gel

CD1579

Overall Number of Participants Analyzed 101 212 104
Measure Type: Number
Unit of Measure: percentage of participants
27.7 44.8 37.5
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 GK530G CD0271 CD1579
Hide Arm/Group Description:

Fixed-dose combination gel of Adapalene and Benzoyl Peroxide

GK530G

Adapalene 01% Gel

CD0271

Benzoyl Peroxide 2.5% Gel

CD1579

Overall Number of Participants Analyzed 212 101 104
Measure Type: Number
Unit of Measure: participants
Mild 78 32 20
Moderate 24 5 4
Severe 2 0 1
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 GK530G CD0271 CD1579
Hide Arm/Group Description:

Fixed-dose combination gel of Adapalene and Benzoyl Peroxide

GK530G

Adapalene 01% Gel

CD0271

Benzoyl Peroxide 2.5% Gel

CD1579

Overall Number of Participants Analyzed 212 101 104
Measure Type: Number
Unit of Measure: participants
Mild 105 37 24
Moderate 33 9 3
Severe 1 1 0
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 GK530G CD0271 CD1579
Hide Arm/Group Description:

Fixed-dose combination gel of Adapalene and Benzoyl Peroxide

GK530G

Adapalene 01% Gel

CD0271

Benzoyl Peroxide 2.5% Gel

CD1579

Overall Number of Participants Analyzed 212 101 104
Measure Type: Number
Unit of Measure: participants
Mild 113 44 29
Moderate 31 6 4
Severe 1 1 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 GK530G CD0271 CD1579
Hide Arm/Group Description:

Fixed-dose combination gel of Adapalene and Benzoyl Peroxide

GK530G

Adapalene 01% Gel

CD0271

Benzoyl Peroxide 2.5% Gel

CD1579

Overall Number of Participants Analyzed 212 101 104
Measure Type: Number
Unit of Measure: participants
Mild 61 24 24
Moderate 21 2 9
Severe 3 0 1
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 GK530G CD0271 CD1579
Hide Arm/Group Description:

Fixed-dose combination gel of Adapalene and Benzoyl Peroxide

GK530G

Adapalene 01% Gel

CD0271

Benzoyl Peroxide 2.5% Gel

CD1579

Overall Number of Participants Analyzed 212 101 104
Measure Type: Number
Unit of Measure: participants
Mild 106 49 21
Moderate 76 11 9
Severe 7 2 1
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CD0271 GK530G CD1579
Hide Arm/Group Description

Adapalene 01% Gel

CD0271

Fixed-dose combination gel of Adapalene and Benzoyl Peroxide

GK530G

Benzoyl Peroxide 2.5% Gel

CD1579

All-Cause Mortality
CD0271 GK530G CD1579
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CD0271 GK530G CD1579
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/101 (0.00%)      0/212 (0.00%)      0/104 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CD0271 GK530G CD1579
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/101 (27.72%)      95/212 (44.81%)      39/104 (37.50%)    
Eye disorders       
Eyelid irritation  0/101 (0.00%)  0 2/212 (0.94%)  2 0/104 (0.00%)  0
Conjunctivitis  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Conjunctivitis allergic  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Dry eye  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Eye pruritus  1/101 (0.99%)  1 0/212 (0.00%)  0 0/104 (0.00%)  0
Eyelid oedema  0/101 (0.00%)  0 0/212 (0.00%)  0 1/104 (0.96%)  1
Gastrointestinal disorders       
Diarrhoea  0/101 (0.00%)  0 4/212 (1.89%)  4 0/104 (0.00%)  0
Gastritis  0/101 (0.00%)  0 2/212 (0.94%)  2 1/104 (0.96%)  1
Stomatitis  0/101 (0.00%)  0 2/212 (0.94%)  2 0/104 (0.00%)  0
Abdominal pain upper  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Cheilitis  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Periodontal disease  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Toothache  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
General disorders       
Pyrexia  1/101 (0.99%)  1 2/212 (0.94%)  2 0/104 (0.00%)  0
Fatigue  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Immune system disorders       
Seasonal allergy  0/101 (0.00%)  0 1/212 (0.47%)  1 1/104 (0.96%)  1
Infections and infestations       
Nasopharyngitis  7/101 (6.93%)  7 18/212 (8.49%)  18 14/104 (13.46%)  15
Pharyngitis  0/101 (0.00%)  0 4/212 (1.89%)  4 1/104 (0.96%)  1
Gastrointestinal infection  0/101 (0.00%)  0 2/212 (0.94%)  2 0/104 (0.00%)  0
Body tinea  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Bronchitis  1/101 (0.99%)  1 1/212 (0.47%)  1 0/104 (0.00%)  0
Furuncle  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Gastroenteritis  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Herpes simplex  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Hordeolum  1/101 (0.99%)  1 1/212 (0.47%)  1 0/104 (0.00%)  0
Influenza  1/101 (0.99%)  1 1/212 (0.47%)  1 1/104 (0.96%)  1
Rhinitis  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Streptococcal infection  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Beta haemolytic streptococcal infection  0/101 (0.00%)  0 0/212 (0.00%)  0 1/104 (0.96%)  1
Oral herpes  1/101 (0.99%)  1 0/212 (0.00%)  0 0/104 (0.00%)  0
Subcutaneous abscess  0/101 (0.00%)  0 0/212 (0.00%)  0 1/104 (0.96%)  1
Tonsillitis  0/101 (0.00%)  0 0/212 (0.00%)  0 1/104 (0.96%)  1
Injury, poisoning and procedural complications       
Arthropod bite  0/101 (0.00%)  0 4/212 (1.89%)  4 0/104 (0.00%)  0
Laceration  0/101 (0.00%)  0 2/212 (0.94%)  2 0/104 (0.00%)  0
Contusion  2/101 (1.98%)  2 1/212 (0.47%)  1 1/104 (0.96%)  1
Scratch  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Heat illness  0/101 (0.00%)  0 0/212 (0.00%)  0 1/104 (0.96%)  1
Ligament sprain  1/101 (0.99%)  1 0/212 (0.00%)  0 1/104 (0.96%)  1
Investigations       
Blood triglycerides increased  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Skin test positive  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
White blood cell count increased  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Neck pain  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Joint lock  0/101 (0.00%)  0 0/212 (0.00%)  0 1/104 (0.96%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Skin papilloma  1/101 (0.99%)  1 5/212 (2.36%)  5 0/104 (0.00%)  0
Ovarian neoplasm  0/101 (0.00%)  0 0/212 (0.00%)  0 1/104 (0.96%)  1
Nervous system disorders       
Headache  0/101 (0.00%)  0 3/212 (1.42%)  5 3/104 (2.88%)  4
Hyperaesthesia  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Reproductive system and breast disorders       
Dysmenorrhoea  3/101 (2.97%)  4 5/212 (2.36%)  5 4/104 (3.85%)  5
Premenstrual syndrome  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Rhinitis allergic  0/101 (0.00%)  0 2/212 (0.94%)  2 1/104 (0.96%)  1
Epistaxis  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Rhinitis perennial  0/101 (0.00%)  0 0/212 (0.00%)  0 1/104 (0.96%)  1
Skin and subcutaneous tissue disorders       
Skin irritation  7/101 (6.93%)  7 26/212 (12.26%)  27 5/104 (4.81%)  5
Eczema  5/101 (4.95%)  5 7/212 (3.30%)  7 1/104 (0.96%)  1
Acne  1/101 (0.99%)  1 3/212 (1.42%)  3 1/104 (0.96%)  1
Dermatitis atopic  1/101 (0.99%)  1 3/212 (1.42%)  4 0/104 (0.00%)  0
Dermatitis allergic  0/101 (0.00%)  0 2/212 (0.94%)  2 1/104 (0.96%)  1
Erythema  0/101 (0.00%)  0 2/212 (0.94%)  2 0/104 (0.00%)  0
Blister  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Eczema asteatotic  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Heat rash  1/101 (0.99%)  1 1/212 (0.47%)  1 0/104 (0.00%)  0
Hyperkeratosis  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Papule  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Photosensitivity reaction  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Pruritus  1/101 (0.99%)  1 1/212 (0.47%)  1 0/104 (0.00%)  0
Seborrhoeic dermatitis  0/101 (0.00%)  0 1/212 (0.47%)  1 2/104 (1.92%)  2
Skin erosion  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Solar dermatitis  0/101 (0.00%)  0 1/212 (0.47%)  1 2/104 (1.92%)  2
Urticaria  0/101 (0.00%)  0 1/212 (0.47%)  1 0/104 (0.00%)  0
Dermatitis contact  0/101 (0.00%)  0 0/212 (0.00%)  0 1/104 (0.96%)  1
Dyshidrosis  0/101 (0.00%)  0 0/212 (0.00%)  0 1/104 (0.96%)  1
Erythema multiforme  0/101 (0.00%)  0 0/212 (0.00%)  0 1/104 (0.96%)  2
Onycholysis  0/101 (0.00%)  0 0/212 (0.00%)  0 1/104 (0.96%)  1
Rash generalised  0/101 (0.00%)  0 0/212 (0.00%)  0 1/104 (0.96%)  1
1
Term from vocabulary, MedDRA 15.0
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: NCT02073448     History of Changes
Other Study ID Numbers: RDT.07.SPR.27123
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