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Trial record 100 of 339 for:    acne AND facial

A Study of Dapsone Gel in Females With Skin of Color and Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT02032407
Recruitment Status : Completed
First Posted : January 10, 2014
Results First Posted : August 19, 2015
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acne Vulgaris
Intervention Drug: Dapsone Gel
Enrollment 68
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dapsone Gel
Hide Arm/Group Description Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Period Title: Overall Study
Started 68
Completed 63
Not Completed 5
Reason Not Completed
Lost to Follow-up             2
Pregnancy             1
Other Miscellaneous Reasons             2
Arm/Group Title Dapsone Gel
Hide Arm/Group Description Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Overall Number of Baseline Participants 67
Hide Baseline Analysis Population Description
Modified Intent-to treat population included all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants
18 to <30 years 32
≥30 to <50 years 32
≥50 years 3
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants
Female
67
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to treat (mITT) population included all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment.
Arm/Group Title Dapsone Gel
Hide Arm/Group Description:
Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Overall Number of Participants Analyzed 67
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 2.8  (0.72)
Change from Baseline at Week 12 -1.2  (0.88)
2.Secondary Outcome
Title Change From Baseline in the GAAS
Time Frame Baseline, Weeks 2 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to treat (mITT) population included all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment.
Arm/Group Title Dapsone Gel
Hide Arm/Group Description:
Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Overall Number of Participants Analyzed 67
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 2.8  (0.72)
Change from Baseline at Week 2 -0.3  (0.63)
Change from Baseline at Week 6 -0.6  (0.74)
3.Secondary Outcome
Title Percent Change From Baseline in Total Lesion Counts
Hide Description The investigator evaluated 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).
Time Frame Baseline, Weeks 2, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Modified Intent-to treat (mITT) population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.
Arm/Group Title Dapsone Gel
Hide Arm/Group Description:
Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Overall Number of Participants Analyzed 67
Mean (Standard Deviation)
Unit of Measure: percent change
Change from Baseline at Week 2 -16.0  (23.45)
Change from Baseline at Week 6 (n=61) -30.0  (26.15)
Change from Baseline at Week 12 (n=63) -52.0  (26.96)
4.Secondary Outcome
Title Percent Change From Baseline in Inflammatory Lesion Counts
Hide Description The investigator evaluated Inflammatory lesions (papule, pustule and nodule/cyst). A negative percent change from baseline indicates a reduction in lesion counts (improvement).
Time Frame Baseline, Weeks 2, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Modified Intent-to treat (mITT) population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.
Arm/Group Title Dapsone Gel
Hide Arm/Group Description:
Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Overall Number of Participants Analyzed 67
Mean (Standard Deviation)
Unit of Measure: percent change
Change from Baseline at Week 2 -25.0  (32.01)
Change from Baseline at Week 6 (n=61) -48.0  (26.72)
Change from Baseline at Week 12 (n=63) -65.0  (23.31)
5.Secondary Outcome
Title Percent Change From Baseline in Non-Inflammatory Lesion Counts
Hide Description The investigator evaluated Non-inflammatory (blackhead and whitehead) lesions. A negative percent change from baseline indicates a reduction in lesion counts (improvement).
Time Frame Baseline, Weeks 2, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Modified Intent-to treat (mITT) population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.
Arm/Group Title Dapsone Gel
Hide Arm/Group Description:
Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Overall Number of Participants Analyzed 67
Mean (Standard Deviation)
Unit of Measure: percent change
Change from Baseline at Week 2 -9.8  (32.03)
Change from Baseline at Week 6 (n=61) -16.0  (36.19)
Change from Baseline at Week 12 (n=63) -41.0  (34.15)
6.Secondary Outcome
Title Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS
Time Frame Weeks 2, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the mITT, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.
Arm/Group Title Dapsone Gel
Hide Arm/Group Description:
Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Overall Number of Participants Analyzed 67
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 6.0
Week 6 (n=61) 13.1
Week 12 (n=63) 42.9
7.Secondary Outcome
Title Acne Symptom and Impact Scale (ASIS) Sign Domain Score
Hide Description The participant 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 answered 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. Higher scores indicate the presence of more severe signs of acne.
Time Frame Weeks 2, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the mITT population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data at the given time-point.
Arm/Group Title Dapsone Gel
Hide Arm/Group Description:
Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Overall Number of Participants Analyzed 67
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 2 1.7  (0.72)
Week 6 (n=60) 1.3  (0.68)
Week 12 (n=63) 1.1  (0.67)
8.Secondary Outcome
Title ASIS Impact Domain Score
Hide Description The participant assessed the impact of acne vulgaris using the ASIS. The impact domain is a composite of 8 items assessing the psychosocial impacts (6 items emotional and 2 items social) of the 17 items on the overall scale. Each of the items is answered on a 5-point scale: 0 (best) to 4 (worst). The impact domain score is calculated as the average of the 8 items for a total possible score of 0 to 4. Higher scores on the ASIS Impact Domain indicate greater negative impact of acne on health-related quality of life and appearance.
Time Frame Weeks 2, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the mITT population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available for analysis at the given time-point.
Arm/Group Title Dapsone Gel
Hide Arm/Group Description:
Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Overall Number of Participants Analyzed 67
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 2 1.6  (0.91)
Week 6 (n=60) 1.3  (0.91)
Week 12 (n=63) 1.1  (0.91)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dapsone Gel
Hide Arm/Group Description Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
All-Cause Mortality
Dapsone Gel
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dapsone Gel
Affected / at Risk (%)
Total   1/68 (1.47%) 
Reproductive system and breast disorders   
Spontaneous abortion  1  1/68 (1.47%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dapsone Gel
Affected / at Risk (%)
Total   0/68 (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: Vice President Medical Affairs,
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02032407     History of Changes
Other Study ID Numbers: GMA-ACZ-13-001
First Submitted: January 8, 2014
First Posted: January 10, 2014
Results First Submitted: June 15, 2015
Results First Posted: August 19, 2015
Last Update Posted: August 19, 2015