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A Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT01974141
Recruitment Status : Completed
First Posted : November 1, 2013
Results First Posted : February 6, 2017
Last Update Posted : October 8, 2018
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Almirall, S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Dapsone Gel
Drug: Dapsone Gel Vehicle
Enrollment 2102
Recruitment Details  
Pre-assignment Details The Intent-to-Treat population is reflected in the overall study properties. This population excludes patients from a site with Good Clinical Practice violations. All data from this site are excluded in the study results.
Arm/Group Title Dapsone Gel Dapsone Gel Vehicle
Hide Arm/Group Description Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks. Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Period Title: Overall Study
Started 1044 1058
Completed 948 976
Not Completed 96 82
Reason Not Completed
Other Reasons             28             18
Protocol Violation             2             6
Personal Reasons             21             20
Lost to Follow-up             38             29
Pregnancy             3             3
Lack of Efficacy             0             1
Adverse Event             4             5
Arm/Group Title Dapsone Gel Dapsone Gel Vehicle Total
Hide Arm/Group Description Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks. Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 1044 1058 2102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1044 participants 1058 participants 2102 participants
20.0  (7.41) 20.0  (7.53) 20.0  (7.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1044 participants 1058 participants 2102 participants
Female
591
  56.6%
582
  55.0%
1173
  55.8%
Male
453
  43.4%
476
  45.0%
929
  44.2%
1.Primary Outcome
Title Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS)
Hide Description The Investigator evaluated the patient's acne severity using the 5-point GAAS scale with 0 being none and 4 being severe. The complete scale is as follow: Grade 0 (none) = No evidence of facila acne vulgaris; Grade 1 (minimal) = Few noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) may be present, no nodulo-cyctic lesions are allowed; Grade 2 (mild) = Several to many noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 3 (moderate) = Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 4 (severe) = Significant degree of inflammatory disease, papules/pustules are a predominant feature, a few nodulo-cystic lesions may be present, comedones may be present.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations
Arm/Group Title Dapsone Gel Dapsone Gel Vehicle
Hide Arm/Group Description:
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Overall Number of Participants Analyzed 1044 1058
Measure Type: Number
Unit of Measure: Percentage of Patients
29.9 21.2
2.Primary Outcome
Title Change From Baseline in Inflammatory Facial Lesion Counts
Hide Description The Investigator evaluated the patient's inflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations
Arm/Group Title Dapsone Gel Dapsone Gel Vehicle
Hide Arm/Group Description:
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Overall Number of Participants Analyzed 1044 1058
Mean (Standard Error)
Unit of Measure: Number of Inflammatory Lesions
Baseline 29.0  (0.25) 29.4  (0.25)
Change from Baseline at Week 12 -16.1  (0.32) -14.1  (0.32)
3.Primary Outcome
Title Change From Baseline in Noninflammatory Facial Lesion Counts
Hide Description The Investigator evaluated the patient's noninflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations
Arm/Group Title Dapsone Gel Dapsone Gel Vehicle
Hide Arm/Group Description:
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Overall Number of Participants Analyzed 1044 1058
Mean (Standard Error)
Unit of Measure: Number of Noninflammatory Lesions
Baseline 47.0  (0.53) 48.7  (0.53)
Change from Baseline at Week 12 -20.8  (0.56) -17.6  (0.55)
4.Secondary Outcome
Title Change From Baseline in Total Lesion Counts
Hide Description The Investigator evaluated the patient's inflammatory (papule, pustule and nodule/cyst) and non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations
Arm/Group Title Dapsone Gel Dapsone Gel Vehicle
Hide Arm/Group Description:
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Overall Number of Participants Analyzed 1044 1058
Least Squares Mean (Standard Error)
Unit of Measure: Total Lesion Counts
Baseline 75.9  (0.65) 78.1  (0.65)
Change from Baseline at Week 12 -36.9  (0.76) -31.7  (0.75)
5.Secondary Outcome
Title Percentage Change From Baseline in Total Lesion Counts
Hide Description The Investigator evaluated the patient's Inflammatory (papule, pustule and nodule/cyst) and Non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative percent change from baseline indicates a reduction in lesion counts (improvement) and a positive percent change from baseline indicates an increase in lesion counts (worsening).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations
Arm/Group Title Dapsone Gel Dapsone Gel Vehicle
Hide Arm/Group Description:
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Overall Number of Participants Analyzed 1044 1058
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change in Lesion Count
-48.7  (0.95) -42.4  (0.93)
6.Secondary Outcome
Title Percentage of Patients Reporting "Very Good" or "Excellent" on Item 10 of the 5-Point Acne Symptom Impact Scale (ASIS)
Hide Description The patient assessed the impact of their acne vulgaris on the look of their face using item 10 on the 5-point ASIS. Item 10 scores range from 1 (Excellent) to 5 (Bad). The percentage of patients who had an ASIS score of 4 (Fair) or 5 (Bad) at baseline and who reported “Very good” or “Excellent” at Week 12 are reported.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients with data at this time point, excluding patients from a site with Good Clinical Practice violations
Arm/Group Title Dapsone Gel Dapsone Gel Vehicle
Hide Arm/Group Description:
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Overall Number of Participants Analyzed 910 913
Measure Type: Number
Unit of Measure: Percentage of Patients
23.8 19.2
7.Secondary Outcome
Title Change From Baseline in the 9-Item ASIS Sign Domain Score
Hide Description The patient assessed signs of acne vulgaris using the ASIS. The sign domain is a composite of 9 items of the 17 items on the overall scale. Each of the items is assessed on a 5-point scale: 0 (best) to 4 (worst). The sign domain score is calculated as the average of the 9 items for a total possible score of 0 to 4. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations
Arm/Group Title Dapsone Gel Dapsone Gel Vehicle
Hide Arm/Group Description:
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Overall Number of Participants Analyzed 1044 1058
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 4.2  (0.69) 4.2  (0.71)
Change from Baseline at Week 12 -0.73  (0.677) -0.69  (0.678)
8.Secondary Outcome
Title Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Oiliness on a the 5-Point ASIS Scale
Hide Description The patient assessed their facial oiliness using item 1 on the 5-point ASIS. Item 1 scores ranged from 0 (Not at all oily) to 4 (Very oily). The percentage of patients who reported at least a 1-grade improvement from baseline in their facial oiliness are reported.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations
Arm/Group Title Dapsone Gel Dapsone Gel Vehicle
Hide Arm/Group Description:
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Overall Number of Participants Analyzed 1044 1058
Measure Type: Number
Unit of Measure: Percentage of Patients
45.7 51.8
9.Secondary Outcome
Title Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Redness on a the 5-Point ASIS Scale
Hide Description The patient assessed their facial redness using item 8 on the 5-point ASIS. Item 8 scores ranged from 0 (Not at all red) to 4 (Very red). The percentage of patients who reported at least a 1-grade improvement from baseline in their facial redness are reported.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations
Arm/Group Title Dapsone Gel Dapsone Gel Vehicle
Hide Arm/Group Description:
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Overall Number of Participants Analyzed 1044 1058
Measure Type: Number
Unit of Measure: Percentage of Patients
55.6 53.0
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety Population was used to assess adverse events and serious adverse events. The Safety Population included all patients who applied study treatment at least once, excluding patients from a site with Good Clinical Practice violations.
 
Arm/Group Title Dapsone Gel Dapsone Gel Vehicle
Hide Arm/Group Description Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks. Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
All-Cause Mortality
Dapsone Gel Dapsone Gel Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dapsone Gel Dapsone Gel Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   3/1044 (0.29%)   5/1057 (0.47%) 
General disorders     
Application Site Dermatitis * 1  1/1044 (0.10%)  0/1057 (0.00%) 
Infections and infestations     
Appendicitis  1  1/1044 (0.10%)  0/1057 (0.00%) 
Injury, poisoning and procedural complications     
Tibia Fracture  1  1/1044 (0.10%)  0/1057 (0.00%) 
Lumbar Vertebral Fracture  1  0/1044 (0.00%)  1/1057 (0.09%) 
Psychiatric disorders     
Affective Disorder  1  0/1044 (0.00%)  1/1057 (0.09%) 
Depression  1  0/1044 (0.00%)  1/1057 (0.09%) 
Anxiety * 1  0/1044 (0.00%)  1/1057 (0.09%) 
Surgical and medical procedures     
Abortion Induced  1 [1]  0/591 (0.00%)  1/581 (0.17%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 17.0
[1]
FEMALES ONLY
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dapsone Gel Dapsone Gel Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1044 (0.00%)   0/1057 (0.00%) 
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.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT01974141     History of Changes
Other Study ID Numbers: 225678-006
First Submitted: October 28, 2013
First Posted: November 1, 2013
Results First Submitted: April 7, 2016
Results First Posted: February 6, 2017
Last Update Posted: October 8, 2018