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A Treatment Regimen for Student Athletes With Mild to Moderate Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT02249104
Recruitment Status : Completed
First Posted : September 25, 2014
Results First Posted : May 26, 2016
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Adapalene/benzoyl peroxide gel, 0.1%/2.5%
Other: Cetaphil Acne Regimen
Enrollment 28
Recruitment Details First subject, first visit: 20 Aug 2014; Single center study
Pre-assignment Details  
Arm/Group Title Acne Treatment
Hide Arm/Group Description

Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily

Cetaphil Acne Regimen:

Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application

Cetaphil® DermaControl™ Foam Wash, at least twice daily

Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy

Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect

Period Title: Overall Study
Started 28
Completed 25
Not Completed 3
Arm/Group Title Acne Treatment
Hide Arm/Group Description

Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily

Cetaphil Acne Regimen:

Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application

Cetaphil® DermaControl™ Foam Wash, at least twice daily

Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy

Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect

Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
<=18 years
27
  96.4%
Between 18 and 65 years
1
   3.6%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
6
  21.4%
Male
22
  78.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
1.Primary Outcome
Title Mean Change From Baseline in Total Lesion Count
Hide Description [Not Specified]
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acne Treatment
Hide Arm/Group Description:

Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily

Cetaphil Acne Regimen:

Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application

Cetaphil® DermaControl™ Foam Wash, at least twice daily

Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy

Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect

Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: Lesions counted
-26.9  (25.3)
2.Secondary Outcome
Title Percent Change From Baseline in Total Lesion Count
Hide Description [Not Specified]
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acne Treatment
Hide Arm/Group Description:

Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily

Cetaphil Acne Regimen:

Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application

Cetaphil® DermaControl™ Foam Wash, at least twice daily

Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy

Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect

Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: Percent change
-29.6  (26.9)
3.Secondary Outcome
Title Mean Change From Baseline in Inflammatory Lesion Count
Hide Description [Not Specified]
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acne Treatment
Hide Arm/Group Description:

Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily

Cetaphil Acne Regimen:

Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application

Cetaphil® DermaControl™ Foam Wash, at least twice daily

Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy

Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect

Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: Lesions counted
-10.8  (9.1)
4.Secondary Outcome
Title Mean Change From Baseline in Non-inflammatory Lesion Count
Hide Description [Not Specified]
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acne Treatment
Hide Arm/Group Description:

Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily

Cetaphil Acne Regimen:

Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application

Cetaphil® DermaControl™ Foam Wash, at least twice daily

Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy

Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect

Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: Lesions counted
-16.3  (20.5)
5.Secondary Outcome
Title Percent Change From Baseline in Inflammatory Lesion Count
Hide Description [Not Specified]
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acne Treatment
Hide Arm/Group Description:

Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily

Cetaphil Acne Regimen:

Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application

Cetaphil® DermaControl™ Foam Wash, at least twice daily

Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy

Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect

Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: Percent change
-35.7  (29.9)
6.Secondary Outcome
Title Percent Change From Baseline in Non-inflammatory Lesion Count
Hide Description [Not Specified]
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acne Treatment
Hide Arm/Group Description:

Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily

Cetaphil Acne Regimen:

Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application

Cetaphil® DermaControl™ Foam Wash, at least twice daily

Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy

Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect

Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: Percent change
-27.1  (34.4)
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acne Treatment
Hide Arm/Group Description

Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily

Cetaphil Acne Regimen:

Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application

Cetaphil® DermaControl™ Foam Wash, at least twice daily

Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy

Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect

All-Cause Mortality
Acne Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Acne Treatment
Affected / at Risk (%) # Events
Total   0/28 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acne Treatment
Affected / at Risk (%) # Events
Total   18/28 (64.29%)    
General disorders   
Application site pain  1  1/28 (3.57%)  1
Immune system disorders   
Gastroenteritis viral  1  1/28 (3.57%)  1
Seasonal allergy  1  2/28 (7.14%)  2
Infections and infestations   
Ear infection  1  1/28 (3.57%)  1
External ear cellulitis  1  1/28 (3.57%)  1
Injury, poisoning and procedural complications   
Sunburn  1  1/28 (3.57%)  1
Concussion  1  1/28 (3.57%)  1
Contusion  1  1/28 (3.57%)  1
Excoriation  1  1/28 (3.57%)  2
Ligament sprain  1  1/28 (3.57%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/28 (3.57%)  1
Oropharyngeal pain  1  1/28 (3.57%)  1
Skin and subcutaneous tissue disorders   
Erythema  1  4/28 (14.29%)  4
Dry skin  1  7/28 (25.00%)  7
Skin exfoliation  1  5/28 (17.86%)  5
Skin burning sensation  1  1/28 (3.57%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0

Open label study with small sample size

Short duration

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.
Investigator may publish, present, or use any results that do not disclose any confidential information furnished by Galderma. The investigator shall provide their draft of such publication to sponsor for review and approval at least 45 days prior to the date of the intended publication. Upon written request from Galderma, within the forty-five (45) day review period, the investigator will delay the publication or presentation for a maximum of an additional one-hundred eighty (180) days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jay Mashburn
Organization: Galderma Laboratories L.P.
Phone: 817 961 5027
EMail: jay.mashburn@galderma.com
Layout table for additonal information
Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT02249104     History of Changes
Other Study ID Numbers: GLI.04.SPR.US10302
First Submitted: September 23, 2014
First Posted: September 25, 2014
Results First Submitted: March 18, 2016
Results First Posted: May 26, 2016
Last Update Posted: May 26, 2016