Trial Outcomes & Findings for A Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris (NCT NCT01974141)
NCT ID: NCT01974141
Last Updated: 2018-10-09
Results Overview
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.
COMPLETED
PHASE3
2102 participants
Week 12
2018-10-09
Participant Flow
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.
Participant milestones
| Measure |
Dapsone Gel
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
Dapsone Gel Vehicle
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
1044
|
1058
|
|
Overall Study
COMPLETED
|
948
|
976
|
|
Overall Study
NOT COMPLETED
|
96
|
82
|
Reasons for withdrawal
| Measure |
Dapsone Gel
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
Dapsone Gel Vehicle
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
Other Reasons
|
28
|
18
|
|
Overall Study
Protocol Violation
|
2
|
6
|
|
Overall Study
Personal Reasons
|
21
|
20
|
|
Overall Study
Lost to Follow-up
|
38
|
29
|
|
Overall Study
Pregnancy
|
3
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Adverse Event
|
4
|
5
|
Baseline Characteristics
A Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Dapsone Gel
n=1044 Participants
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
Dapsone Gel Vehicle
n=1058 Participants
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
Total
n=2102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.0 Years
STANDARD_DEVIATION 7.41 • n=5 Participants
|
20.0 Years
STANDARD_DEVIATION 7.53 • n=7 Participants
|
20.0 Years
STANDARD_DEVIATION 7.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
591 Participants
n=5 Participants
|
582 Participants
n=7 Participants
|
1173 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
453 Participants
n=5 Participants
|
476 Participants
n=7 Participants
|
929 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations
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.
Outcome measures
| Measure |
Dapsone Gel
n=1044 Participants
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
Dapsone Gel Vehicle
n=1058 Participants
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS)
|
29.9 Percentage of Patients
|
21.2 Percentage of Patients
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations
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).
Outcome measures
| Measure |
Dapsone Gel
n=1044 Participants
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
Dapsone Gel Vehicle
n=1058 Participants
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Inflammatory Facial Lesion Counts
Baseline
|
29.0 Number of Inflammatory Lesions
Standard Error 0.25
|
29.4 Number of Inflammatory Lesions
Standard Error 0.25
|
|
Change From Baseline in Inflammatory Facial Lesion Counts
Change from Baseline at Week 12
|
-16.1 Number of Inflammatory Lesions
Standard Error 0.32
|
-14.1 Number of Inflammatory Lesions
Standard Error 0.32
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations
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).
Outcome measures
| Measure |
Dapsone Gel
n=1044 Participants
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
Dapsone Gel Vehicle
n=1058 Participants
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Noninflammatory Facial Lesion Counts
Baseline
|
47.0 Number of Noninflammatory Lesions
Standard Error 0.53
|
48.7 Number of Noninflammatory Lesions
Standard Error 0.53
|
|
Change From Baseline in Noninflammatory Facial Lesion Counts
Change from Baseline at Week 12
|
-20.8 Number of Noninflammatory Lesions
Standard Error 0.56
|
-17.6 Number of Noninflammatory Lesions
Standard Error 0.55
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations
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).
Outcome measures
| Measure |
Dapsone Gel
n=1044 Participants
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
Dapsone Gel Vehicle
n=1058 Participants
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Total Lesion Counts
Baseline
|
75.9 Total Lesion Counts
Standard Error 0.65
|
78.1 Total Lesion Counts
Standard Error 0.65
|
|
Change From Baseline in Total Lesion Counts
Change from Baseline at Week 12
|
-36.9 Total Lesion Counts
Standard Error 0.76
|
-31.7 Total Lesion Counts
Standard Error 0.75
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations
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).
Outcome measures
| Measure |
Dapsone Gel
n=1044 Participants
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
Dapsone Gel Vehicle
n=1058 Participants
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
|---|---|---|
|
Percentage Change From Baseline in Total Lesion Counts
|
-48.7 Percent Change in Lesion Count
Standard Error 0.95
|
-42.4 Percent Change in Lesion Count
Standard Error 0.93
|
SECONDARY outcome
Timeframe: Week 12Population: Intent-to-Treat: all randomized patients with data at this time point, excluding patients from a site with Good Clinical Practice violations
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.
Outcome measures
| Measure |
Dapsone Gel
n=910 Participants
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
Dapsone Gel Vehicle
n=913 Participants
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Patients Reporting "Very Good" or "Excellent" on Item 10 of the 5-Point Acne Symptom Impact Scale (ASIS)
|
23.8 Percentage of Patients
|
19.2 Percentage of Patients
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations
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.
Outcome measures
| Measure |
Dapsone Gel
n=1044 Participants
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
Dapsone Gel Vehicle
n=1058 Participants
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in the 9-Item ASIS Sign Domain Score
Baseline
|
4.2 Scores on a Scale
Standard Deviation 0.69
|
4.2 Scores on a Scale
Standard Deviation 0.71
|
|
Change From Baseline in the 9-Item ASIS Sign Domain Score
Change from Baseline at Week 12
|
-0.73 Scores on a Scale
Standard Deviation 0.677
|
-0.69 Scores on a Scale
Standard Deviation 0.678
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations
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.
Outcome measures
| Measure |
Dapsone Gel
n=1044 Participants
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
Dapsone Gel Vehicle
n=1058 Participants
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Oiliness on a the 5-Point ASIS Scale
|
45.7 Percentage of Patients
|
51.8 Percentage of Patients
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations
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.
Outcome measures
| Measure |
Dapsone Gel
n=1044 Participants
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
Dapsone Gel Vehicle
n=1058 Participants
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Redness on a the 5-Point ASIS Scale
|
55.6 Percentage of Patients
|
53.0 Percentage of Patients
|
Adverse Events
Dapsone Gel
Dapsone Gel Vehicle
Serious adverse events
| Measure |
Dapsone Gel
n=1044 participants at risk
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
Dapsone Gel Vehicle
n=1057 participants at risk
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
|---|---|---|
|
General disorders
Application Site Dermatitis
|
0.10%
1/1044
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.
|
0.00%
0/1057
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.
|
|
Infections and infestations
Appendicitis
|
0.10%
1/1044
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.
|
0.00%
0/1057
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.
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.10%
1/1044
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.
|
0.00%
0/1057
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.
|
|
Surgical and medical procedures
Abortion Induced
|
0.00%
0/591
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.
|
0.17%
1/581
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.
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/1044
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.
|
0.09%
1/1057
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.
|
|
Psychiatric disorders
Affective Disorder
|
0.00%
0/1044
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.
|
0.09%
1/1057
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.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1044
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.
|
0.09%
1/1057
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.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1044
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.
|
0.09%
1/1057
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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER