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

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ClinicalTrials.gov Identifier: NCT01974323
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 2238
Recruitment Details  
Pre-assignment Details  
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 1118 1120
Completed 1026 1027
Not Completed 92 93
Reason Not Completed
Other Reasons             25             28
Protocol Violation             2             2
Personal Reasons             15             19
Lost to Follow-up             45             40
Pregnancy             2             1
Lack of Efficacy             1             1
Adverse Event             2             2
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 1118 1120 2238
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1118 participants 1120 participants 2238 participants
20.5  (8.15) 20.4  (7.38) 20.4  (7.77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1118 participants 1120 participants 2238 participants
Female
618
  55.3%
631
  56.3%
1249
  55.8%
Male
500
  44.7%
489
  43.7%
989
  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
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 1118 1120
Measure Type: Number
Unit of Measure: Percentage of Patients
29.8 20.9
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
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 1118 1120
Mean (Standard Error)
Unit of Measure: Number of Inflammatory Lesions
Baseline 29.6  (0.23) 30.0  (0.23)
Change from Baseline at Week 12 -15.6  (0.35) -14.0  (0.35)
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
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 1118 1120
Mean (Standard Error)
Unit of Measure: Number of Noninflammatory Lesions
Baseline 46.7  (0.46) 46.7  (0.46)
Change from Baseline at Week 12 -20.8  (0.55) -18.7  (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
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 1118 1120
Least Squares Mean (Standard Error)
Unit of Measure: Total Lesion Counts
Baseline 76.4  (0.56) 76.9  (0.56)
Change from Baseline at Week 12 -36.2  (0.76) -32.3  (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
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 1118 1120
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change in Lesion Count
-48.9  (0.97) -43.2  (0.97)
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
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 926 961
Measure Type: Number
Unit of Measure: Percentage of Patients
24.2 22.0
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
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 1118 1120
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 2.04  (0.627) 2.07  (0.612)
Change from Baseline at Week 12 -0.74  (0.700) -0.68  (0.675)
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
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 1118 1120
Measure Type: Number
Unit of Measure: Percentage of Patients
48.5 49.3
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
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 1118 1120
Measure Type: Number
Unit of Measure: Percentage of Patients
53.8 52.9
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 were treated with at least 1 application of study treatment
 
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   4/1117 (0.36%)   4/1118 (0.36%) 
Gastrointestinal disorders     
Peritoneal Haematoma  1  1/1117 (0.09%)  0/1118 (0.00%) 
Infections and infestations     
Appendicitis  1  1/1117 (0.09%)  1/1118 (0.09%) 
Helicobacter Infection  1  1/1117 (0.09%)  0/1118 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute Myeloid Leukaemia  1  1/1117 (0.09%)  0/1118 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion Spontaneous  1 [1]  0/618 (0.00%)  1/631 (0.16%) 
Psychiatric disorders     
Alchoholism * 1  1/1117 (0.09%)  0/1118 (0.00%) 
Suicidal Ideation * 1  0/1117 (0.00%)  1/1118 (0.09%) 
Respiratory, thoracic and mediastinal disorders     
Pneumothorax Spontaneous  1  0/1117 (0.00%)  1/1118 (0.09%) 
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   0/1117 (0.00%)   0/1118 (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: NCT01974323     History of Changes
Obsolete Identifiers: NCT02786745
Other Study ID Numbers: 225678-007
First Submitted: October 28, 2013
First Posted: November 1, 2013
Results First Submitted: May 5, 2016
Results First Posted: February 6, 2017
Last Update Posted: October 8, 2018