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This was a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations were performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a participant should remain the same during the study.
The primary objective was to demonstrate the superiority in efficacy and assess safety of adapalene/benzoyl peroxide topical gel (adapalene/benzoyl peroxide gel) versus adapalene topical gel, 0.1% (adapalene monad); benzoyl peroxide topical gel, 2.5% (benzoyl peroxide monad) and topical gel vehicle (gel vehicle) in the treatment of acne vulgaris for up to 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapalene/Benzoyl Peroxide Gel | Experimental | Participants were treated with adapalene 0.1 % [weight by weight (W/W)]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks. |
|
| Adapalene Gel, 0.1% | Experimental | Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks. |
|
| Benzoyl Peroxide Gel 2.5% | Experimental | Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks. |
|
| Gel Vehicle | Placebo Comparator | Participants were treated with gel vehicle topically daily in the evening for 12 Weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene/Benzoyl Peroxide | Drug | Adapalene 0.1 % [weight by weight (W/W)]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward) | Success rate was defined as percentage of participants who achieved "Clear" or "Almost Clear" score on the IGA scale. IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). All missing values were imputed by LOCF. | At Week 12 |
| Change in Inflammatory Lesion Count From Baseline to Week 12 | Change in inflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF. | Baseline to Week 12 |
| Change in Noninflammatory Lesion Count From Baseline to Week 12 | Change in noninflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 | The Inflammatory Lesion Count was the sum of papules and pustules. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value * 100. All missing values were imputed by LOCF. | Baseline, Week 12 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Graeber, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miller MD | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12963896 | Background | Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. doi: 10.1067/s0190-9622(03)01154-x. | |
| 19746769 | Derived | Gold LS, Tan J, Cruz-Santana A, Papp K, Poulin Y, Schlessinger J, Gidner J, Liu Y, Graeber M; Adapalene-BPO Study Group. A North American study of adapalene-benzoyl peroxide combination gel in the treatment of acne. Cutis. 2009 Aug;84(2):110-6. |
| Label | URL |
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| Related Info | View source |
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A total of 1668 participants with acne vulgaris were randomized, administered and enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adapalene/Benzoyl Peroxide Gel | Participants were treated with adapalene 0.1 % [weight by weight (W/W)]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks. |
| FG001 | Adapalene Gel, 0.1% | Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks. |
| FG002 | Benzoyl Peroxide Gel 2.5% | Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks. |
| FG003 | Gel Vehicle | Participants were treated with gel vehicle topically daily in the evening for 12 Weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ITT (Intent-to-Treat) Population included all treated participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Adapalene/Benzoyl Peroxide Gel | Participants were treated with adapalene 0.1 % (W/W)/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks. |
| BG001 | Adapalene Gel, 0.1% |
| 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 Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward) | Success rate was defined as percentage of participants who achieved "Clear" or "Almost Clear" score on the IGA scale. IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). All missing values were imputed by LOCF. | ITT (Intent-To-Treat) Population included all treated participants. Here, Overall Number of Participants Analyzed = Participants with available data for this outcome measure. | Posted | Number | percentage of participants | At Week 12 |
|
From start of the study drug administration up to Week 12.
Analysis was performed on safety population that included all participants who applied the study medication at least once.
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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 | Adapalene/Benzoyl Peroxide Gel | Participants were treated with adapalene 0.1 % (W/W)/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA 6.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 6.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | 1 | Clinical.Studies@galderma.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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| ID | Term |
|---|---|
| D000068801 | Adapalene, Benzoyl Peroxide Drug Combination |
| D005782 | Gels |
| ID | Term |
|---|---|
| D001585 | Benzoyl Peroxide |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| Adapalene Gel, 0.1% | Drug | 0.1% of adapalene gel topically daily in the evening for 12 Weeks. |
|
| Benzoyl Peroxide Gel 2.5% | Drug | 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks. |
|
| Gel Vehicle | Drug | Participants were treated with gel vehicle topically daily in the evening for 12 Weeks. |
|
| Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12 |
The Noninflammatory Lesion Count was the sum of open comedones and closed comedones. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value * 100. All missing values were imputed by LOCF. |
| Baseline, Week 12 |
| Percent Change From Baseline in Total Lesion Counts at Week 12 | The Total Lesion Count was the sum of Inflammatory, Noninflammatory Lesion Counts, Nodules and Cysts. | Baseline, Week 12 |
| Adverse Event |
|
| Subject request |
|
| Protocol Violation |
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| Lost to Follow-up |
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| Other |
|
| Pregnancy |
|
Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks.
| BG002 | Benzoyl Peroxide Gel 2.5% | Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks. |
| BG003 | Gel Vehicle | Participants were treated with gel vehicle topically daily in the evening for 12 Weeks. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG000 | Adapalene/Benzoyl Peroxide Gel | Participants were treated with adapalene 0.1 % [weight by weight (W/W))]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks. |
| OG001 | Adapalene Gel, 0.1% | Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks. |
| OG002 | Benzoyl Peroxide Gel 2.5% | Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks. |
| OG003 | Gel Vehicle | Participants were treated with gel vehicle topically daily in the evening for 12 Weeks. |
|
|
| Primary | Change in Inflammatory Lesion Count From Baseline to Week 12 | Change in inflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF. | ITT Population included all treated participants. | Posted | Median | Inter-Quartile Range | lesions | Baseline to Week 12 |
|
|
|
| Primary | Change in Noninflammatory Lesion Count From Baseline to Week 12 | Change in noninflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF. | ITT Population included all treated participants. | Posted | Median | Inter-Quartile Range | lesions | Baseline to Week 12 |
|
|
|
| Secondary | Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 | The Inflammatory Lesion Count was the sum of papules and pustules. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value * 100. All missing values were imputed by LOCF. | ITT Population included all treated participants. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 12 |
|
|
|
| Secondary | Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12 | The Noninflammatory Lesion Count was the sum of open comedones and closed comedones. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value * 100. All missing values were imputed by LOCF. | ITT Population included all treated participants. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 12 |
|
|
|
| Secondary | Percent Change From Baseline in Total Lesion Counts at Week 12 | The Total Lesion Count was the sum of Inflammatory, Noninflammatory Lesion Counts, Nodules and Cysts. | ITT Population included all treated participants. | Posted | Mean | Standard Deviation | percent change in lesions | Baseline, Week 12 |
|
|
|
| 0 |
| 415 |
| 2 |
| 415 |
| 44 |
| 415 |
| EG001 | Adapalene Gel, 0.1% | Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks. | 0 | 420 | 3 | 420 | 51 | 420 |
| EG002 | Benzoyl Peroxide Gel 2.5% | Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks. | 0 | 415 | 0 | 415 | 29 | 415 |
| EG003 | Gel Vehicle | Participants were treated with gel vehicle topically daily in the evening for 12 Weeks. | 0 | 418 | 1 | 418 | 34 | 418 |
| Suicide attempt | Psychiatric disorders | MedDRA 6.1 | Systematic Assessment |
|
| Affective disorder | Psychiatric disorders | MedDRA 6.1 | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 6.1 | Systematic Assessment |
|
| Cellulitis staphylococcal | Infections and infestations | MedDRA 6.1 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 6.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 6.1 | Systematic Assessment |
|
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| D009930 |
| Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000068816 | Adapalene |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| Change at Week 12 |
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| Change at Week 12 |
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