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Trial record 61 of 134 for:    acne AND peroxide

Effect of Samples on Acne Treatment With Epiduo® Gel

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ClinicalTrials.gov Identifier: NCT01504204
Recruitment Status : Completed
First Posted : January 5, 2012
Results First Posted : January 23, 2018
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
Galderma Laboratories, L.P.
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Adapalene + benzoyl peroxide samples
Drug: Adapalene + benzoyl peroxide from standard tube
Enrollment 20
Recruitment Details Subjects were recruited from Wake Forest Baptist Medical Center Dermatology clinic and phone database of previously seen mild to moderate acne.
Pre-assignment Details  
Arm/Group Title Medication With Sample and Demonstration Medication Without Samples
Hide Arm/Group Description Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit. Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.
Period Title: Overall Study
Started 10 10
Completed 9 9
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             1
Arm/Group Title Medication With Sample and Demonstration Medication Without Samples Total
Hide Arm/Group Description

Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.

Adapalene + benzoyl peroxide samples: A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.

Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.

Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.

Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.

Total of all reporting groups
Overall Number of Baseline Participants 9 9 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Age Number Analyzed 9 participants 9 participants 18 participants
19
(13 to 31)
19
(13 to 29)
19
(13 to 31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
Female
8
  88.9%
6
  66.7%
14
  77.8%
Male
1
  11.1%
3
  33.3%
4
  22.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
Race(Caucasian)
5
  55.6%
6
  66.7%
11
  61.1%
Ethnicity(Non-Hispanic)
8
  88.9%
9
 100.0%
17
  94.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 9 participants 9 participants 18 participants
9
 100.0%
9
 100.0%
18
 100.0%
1.Primary Outcome
Title Adherence to Study Medication
Hide Description Adherence will be reported as percentage of prescribed doses taken as measured electronically by a Medication Event Monitoring System (MEMS®) cap.
Time Frame Baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
the median and ranges of subject ages for the sample and no sample group were 19 years, primarily female identifying as Caucasian.
Arm/Group Title Medication With Sample and Demonstration Medication Without Samples
Hide Arm/Group Description:

Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.

Adapalene + benzoyl peroxide samples: A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.

Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.

Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.

Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.

Overall Number of Participants Analyzed 9 9
Median (Standard Deviation)
Unit of Measure: percentage of doses
86  (2.2) 71  (0.34)
2.Secondary Outcome
Title Change in Acne Global Assessment
Hide Description Change in the physician's global assessment of acne severity on a validated 0-5 scale (0=clear to 5=very severe) from baseline to Week 6 visit.
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medication With Sample and Demonstration Medication Without Samples
Hide Arm/Group Description:

Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.

Adapalene + benzoyl peroxide samples: A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.

Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.

Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.

Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.

Overall Number of Participants Analyzed 9 9
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline AGA (2-mild)
5
  55.6%
6
  66.7%
AGA (3 moderate)
4
  44.4%
3
  33.3%
AGA (1 almost clear)
0
   0.0%
0
   0.0%
Week 6 AGA (2-mild)
3
  33.3%
4
  44.4%
AGA (3 moderate)
2
  22.2%
3
  33.3%
AGA (1 almost clear)
4
  44.4%
2
  22.2%
3.Secondary Outcome
Title Change in Acne Lesion Count
Hide Description Change in total count of acne lesions from baseline visit to Week 6 visit
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medication With Sample and Demonstration Medication Without Samples
Hide Arm/Group Description:

Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.

Adapalene + benzoyl peroxide samples: A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.

Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.

Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.

Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.

Overall Number of Participants Analyzed 9 9
Mean (Full Range)
Unit of Measure: lesions
Basleine (Inflammatory Lesions)
3
(0 to 10)
2
(0 to 12)
Baseline (Non-Inflammatory)
33
(16 to 57)
38
(6 to 62)
Week 6 (inflammatory Lesion)
1
(0 to 9)
1
(0 to 14)
Week 6 (Non-inflammatory Lesion)
19
(5 to 40)
35
(4 to 53)
Time Frame One year
Adverse Event Reporting Description Eighteen subjects completed questionnaires regarding side effects.
 
Arm/Group Title Medication With Sample and Demonstration Medication Without Samples
Hide Arm/Group Description

Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.

Adapalene + benzoyl peroxide samples: A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.

Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.

Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.

Adapalene + benzoyl peroxide from standard tube: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.

All-Cause Mortality
Medication With Sample and Demonstration Medication Without Samples
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Medication With Sample and Demonstration Medication Without Samples
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Medication With Sample and Demonstration Medication Without Samples
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/10 (60.00%)      6/10 (60.00%)    
Skin and subcutaneous tissue disorders     
Dryness  [1]  3/10 (30.00%)  3 3/10 (30.00%)  3
itching  [2]  3/10 (30.00%)  3 2/10 (20.00%)  2
redness  [3]  0/10 (0.00%)  0 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
[1]
Dry skin
[2]
Skin itching
[3]
red skin
This small pilot study subgroup analyses was limited.
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: Irma M Richardsom, MHA
Organization: Wake Forest University Health Sciences
Phone: 336-716-2903
EMail: irichard@wakehealth.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
ClinicalTrials.gov Identifier: NCT01504204     History of Changes
Other Study ID Numbers: IRB00015374
First Submitted: December 28, 2011
First Posted: January 5, 2012
Results First Submitted: October 31, 2017
Results First Posted: January 23, 2018
Last Update Posted: September 12, 2018