Trial · NCT01974323
Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris
NCT01974323, Phase 3, Completed, Almirall, S.A.; results first posted 2017-02-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris. Trials, record NCT01974323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01974323
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris
- NCT number
- NCT01974323
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,238 participants, actual
- Lead sponsor
- Almirall, S.A.
- Conditions
- Acne Vulgaris
- Interventions
- Dapsone Gel, Dapsone Gel Vehicle
- First posted
- 2013-11-01
- Last updated
- 2018-10-09
- Results first posted
- 2017-02-06
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS) | Week 12 | 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. |
| Primary | Change From Baseline in Inflammatory Facial Lesion Counts | Baseline, Week 12 | 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). |
| Primary | Change From Baseline in Noninflammatory Facial Lesion Counts | Baseline, Week 12 | 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). |
| Secondary | Change From Baseline in Total Lesion Counts | Baseline, Week 12 | 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). |
| Secondary | Percentage Change From Baseline in Total Lesion Counts | Baseline, Week 12 | 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). |
| Secondary | Percentage of Patients Reporting "Very Good" or "Excellent" on Item 10 of the 5-Point Acne Symptom Impact Scale (ASIS) | Week 12 | 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. |
| Secondary | Change From Baseline in the 9-Item ASIS Sign Domain Score | Baseline, Week 12 | 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. |
| Secondary | Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Oiliness on a the 5-Point ASIS Scale | Baseline, Week 12 | 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. |
| Secondary | Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Redness on a the 5-Point ASIS Scale | Baseline, Week 12 | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS) | Week 12 | Intent-to-Treat: all randomized patients | Percentage of Patients | NUMBER |
| PRIMARY | Change From Baseline in Inflammatory Facial Lesion Counts | Baseline, Week 12 | Intent-to-Treat: all randomized patients | Number of Inflammatory Lesions | MEAN |
| PRIMARY | Change From Baseline in Noninflammatory Facial Lesion Counts | Baseline, Week 12 | Intent-to-Treat: all randomized patients | Number of Noninflammatory Lesions | MEAN |
| SECONDARY | Change From Baseline in Total Lesion Counts | Baseline, Week 12 | Intent-to-Treat: all randomized patients | Total Lesion Counts | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline in Total Lesion Counts | Baseline, Week 12 | Intent-to-Treat: all randomized patients | Percent Change in Lesion Count | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients Reporting Very Good or Excellent on Item 10 of the 5-Point Acne Symptom Impact Scale (ASIS) | Week 12 | Intent-to-Treat: all randomized patients with data at this time point | Percentage of Patients | NUMBER |
| SECONDARY | Change From Baseline in the 9-Item ASIS Sign Domain Score | Baseline, Week 12 | Intent-to-Treat: all randomized patients | Scores on a Scale | MEAN |
| SECONDARY | Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Oiliness on a the 5-Point ASIS Scale | Baseline, Week 12 | Intent-to-Treat: all randomized patients | Percentage of Patients | NUMBER |
| SECONDARY | Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Redness on a the 5-Point ASIS Scale | Baseline, Week 12 | Intent-to-Treat: all randomized patients | Percentage of Patients | NUMBER |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS) | Dapsone Gel | 29.8 | Percentage of Patients | ||
| Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS) | Dapsone Gel Vehicle | 20.9 | Percentage of Patients | ||
| Change From Baseline in Inflammatory Facial Lesion Counts | Dapsone Gel | Baseline | 29.6 | Standard Error 0.23 | Number of Inflammatory Lesions |
| Change From Baseline in Inflammatory Facial Lesion Counts | Dapsone Gel Vehicle | Baseline | 30.0 | Standard Error 0.23 | Number of Inflammatory Lesions |
| Change From Baseline in Inflammatory Facial Lesion Counts | Dapsone Gel | Change from Baseline at Week 12 | -15.6 | Standard Error 0.35 | Number of Inflammatory Lesions |
| Change From Baseline in Inflammatory Facial Lesion Counts | Dapsone Gel Vehicle | Change from Baseline at Week 12 | -14.0 | Standard Error 0.35 | Number of Inflammatory Lesions |
| Change From Baseline in Noninflammatory Facial Lesion Counts | Dapsone Gel | Baseline | 46.7 | Standard Error 0.46 | Number of Noninflammatory Lesions |
| Change From Baseline in Noninflammatory Facial Lesion Counts | Dapsone Gel Vehicle | Baseline | 46.7 | Standard Error 0.46 | Number of Noninflammatory Lesions |
| Change From Baseline in Noninflammatory Facial Lesion Counts | Dapsone Gel | Change from Baseline at Week 12 | -20.8 | Standard Error 0.55 | Number of Noninflammatory Lesions |
| Change From Baseline in Noninflammatory Facial Lesion Counts | Dapsone Gel Vehicle | Change from Baseline at Week 12 | -18.7 | Standard Error 0.55 | Number of Noninflammatory Lesions |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dapsone Gel | 1,118 | |
| Overall Study | STARTED | Dapsone Gel Vehicle | 1,120 | |
| Overall Study | COMPLETED | Dapsone Gel | 1,026 | |
| Overall Study | COMPLETED | Dapsone Gel Vehicle | 1,027 | |
| Overall Study | NOT COMPLETED | Dapsone Gel | 92 | |
| Overall Study | NOT COMPLETED | Dapsone Gel Vehicle | 93 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Peritoneal Haematoma | Gastrointestinal disorders | Dapsone Gel | 1 | 1,117 | |
| serious | Peritoneal Haematoma | Gastrointestinal disorders | Dapsone Gel Vehicle | 0 | 1,118 | |
| serious | Appendicitis | Infections and infestations | Dapsone Gel | 1 | 1,117 | |
| serious | Appendicitis | Infections and infestations | Dapsone Gel Vehicle | 1 | 1,118 | |
| serious | Helicobacter Infection | Infections and infestations | Dapsone Gel | 1 | 1,117 | |
| serious | Helicobacter Infection | Infections and infestations | Dapsone Gel Vehicle | 0 | 1,118 | |
| serious | Acute Myeloid Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Dapsone Gel | 1 | 1,117 | |
| serious | Acute Myeloid Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Dapsone Gel Vehicle | 0 | 1,118 | |
| serious | Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | Dapsone Gel | 0 | 618 | |
| serious | Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | Dapsone Gel Vehicle | 1 | 631 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dapsone Gel | ||
| Total, all-cause mortality | Dapsone Gel Vehicle | ||
| Total, other adverse events | Dapsone Gel | 0 | 1,117 |
| Total, other adverse events | Dapsone Gel Vehicle | 0 | 1,118 |
| Total, serious adverse events | Dapsone Gel | 4 | 1,117 |
| Total, serious adverse events | Dapsone Gel Vehicle | 4 | 1,118 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dapsone Gel vs Dapsone Gel Vehicle: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01974323
GET https://conductscience.org/api/trials/v1/NCT01974323/results?page=2