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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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This study will assess the safety and efficacy of dapsone gel versus vehicle control in patients with acne vulgaris.
This is a multicenter, double-blind, randomized, parallel-group, vehicle-controlled study to assess the safety and efficacy of dapsone 7.5% gel versus vehicle administered topically once daily for 12 weeks in patients with acne vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapsone Gel | Experimental | Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks. |
|
| Dapsone Gel Vehicle | Placebo Comparator | Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapsone Gel | Drug | Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS) | 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. | Week 12 |
| Change From Baseline in Inflammatory Facial Lesion Counts | 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). | Baseline, Week 12 |
| Change From Baseline in Noninflammatory Facial Lesion Counts | 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). | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Lesion Counts | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beverly Hills | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30500141 | Derived | Tanghetti E, Harper J, Baldwin H, Kircik L, Bai Z, Alvandi N. Once-Daily Topical Dapsone Gel, 7.5%: Effective for Acne Vulgaris Regardless of Baseline Lesion Count, With Superior Efficacy in Females. J Drugs Dermatol. 2018 Nov 1;17(11):1192-1198. | |
| 30500140 | Derived | Tanghetti E, Harper J, Baldwin H, Kircik L, Bai Z, Alvandi N. Once-Daily Topical Dapsone Gel, 7.5%: Effective for Acne Vulgaris Regardless of Baseline Lesion Count, With Superior Efficacy in Females. J Drugs Dermatol. 2018 Nov 1;17(11):1192-1198. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dapsone Gel | Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks. |
| FG001 | Dapsone Gel Vehicle | Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dapsone Gel | Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks. |
| BG001 | Dapsone Gel Vehicle | Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS) | 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. | Intent-to-Treat: all randomized patients | Posted | Number | Percentage of Patients | Week 12 |
|
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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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dapsone Gel | Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peritoneal Haematoma | Gastrointestinal disorders | MedDRA version 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| Dapsone Gel Vehicle | Drug | Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks. |
|
| Baseline, Week 12 |
| Percentage Change From Baseline in Total Lesion Counts | 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). | Baseline, Week 12 |
| Percentage of Patients Reporting "Very Good" or "Excellent" on Item 10 of the 5-Point Acne Symptom Impact Scale (ASIS) | 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. | Week 12 |
| Change From Baseline in the 9-Item ASIS Sign Domain Score | 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. | Baseline, Week 12 |
| Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Oiliness on a the 5-Point ASIS Scale | 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. | Baseline, Week 12 |
| Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Redness on a the 5-Point ASIS Scale | 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. | Baseline, Week 12 |
| Aventura |
| Florida |
| United States |
| Windsor | Ontario | Canada |
| 30500139 | Derived | Tanghetti E, Harper J, Baldwin H, Kircik L, Bai Z, Alvandi N. Once-Daily Topical Dapsone Gel, 7.5%: Effective for Acne Vulgaris Regardless of Baseline Lesion Count, With Superior Efficacy in Females. J Drugs Dermatol. 2018 Nov 1;17(11):1192-1198. |
| 27847545 | Derived | Thiboutot DM, Kircik L, McMichael A, Cook-Bolden FE, Tyring SK, Berk DR, Chang-Lin JE, Lin V, Kaoukhov A. Efficacy, Safety, and Dermal Tolerability of Dapsone Gel, 7.5% in Patients with Moderate Acne Vulgaris: A Pooled Analysis of Two Phase 3 Trials. J Clin Aesthet Dermatol. 2016 Oct;9(10):18-27. Epub 2016 Oct 1. |
| Personal Reasons |
|
| Lost to Follow-up |
|
| Pregnancy |
|
| Lack of Efficacy |
|
| Adverse Event |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 | Dapsone Gel | Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks. |
| OG001 | Dapsone Gel Vehicle | Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks. |
|
|
| Primary | Change From Baseline in Inflammatory Facial Lesion Counts | 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). | Intent-to-Treat: all randomized patients | Posted | Mean | Standard Error | Number of Inflammatory Lesions | Baseline, Week 12 |
|
|
|
| Primary | Change From Baseline in Noninflammatory Facial Lesion Counts | 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). | Intent-to-Treat: all randomized patients | Posted | Mean | Standard Error | Number of Noninflammatory Lesions | Baseline, Week 12 |
|
|
|
| Secondary | Change From Baseline in Total Lesion Counts | 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). | Intent-to-Treat: all randomized patients | Posted | Least Squares Mean | Standard Error | Total Lesion Counts | Baseline, Week 12 |
|
|
|
| Secondary | Percentage Change From Baseline in Total Lesion Counts | 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). | Intent-to-Treat: all randomized patients | Posted | Least Squares Mean | Standard Error | Percent Change in Lesion Count | Baseline, Week 12 |
|
|
|
| Secondary | Percentage of Patients Reporting "Very Good" or "Excellent" on Item 10 of the 5-Point Acne Symptom Impact Scale (ASIS) | 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. | Intent-to-Treat: all randomized patients with data at this time point | Posted | Number | Percentage of Patients | Week 12 |
|
|
|
| Secondary | Change From Baseline in the 9-Item ASIS Sign Domain Score | 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. | Intent-to-Treat: all randomized patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Week 12 |
|
|
|
| Secondary | Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Oiliness on a the 5-Point ASIS Scale | 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. | Intent-to-Treat: all randomized patients | Posted | Number | Percentage of Patients | Baseline, Week 12 |
|
|
|
| Secondary | Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Redness on a the 5-Point ASIS Scale | 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. | Intent-to-Treat: all randomized patients | Posted | Number | Percentage of Patients | Baseline, Week 12 |
|
|
|
| 4 |
| 1,117 |
| 0 |
| 1,117 |
| EG001 | Dapsone Gel Vehicle | Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks. | 4 | 1,118 | 0 | 1,118 |
| Appendicitis | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
|
| Helicobacter Infection | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
|
| Acute Myeloid Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
|
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA version 17.0 | Systematic Assessment | FEMALES ONLY |
|
| Alchoholism | Psychiatric disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Pneumothorax Spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | Systematic Assessment |
|
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.