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| Name | Class |
|---|---|
| Bausch Health Americas, Inc. | INDUSTRY |
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The study team plans to enroll a total of 40 subjects with self-reported perimenstrual acne. Eligible women will be over the age of 18 and not on any current therapy. The patients will first arrive for a screening visit, where they will be given questionnaires on acne quality of life (acne QOL) and subjective assessments as well as flare ups (as used in the study by Geller et al). The patients' skin will be assessed for inflammatory and non-inflammatory acne vulgaris. The baseline visit (day 1) will be scheduled for one week prior to the first day of menses (as studies indicate that most women have their acne flare during this time). The study team will perform a zit count (counting papules, pustules, and comedones) and global assessment, and the patient will be instructed to record their menses (which they will do for the duration of the study). The patients will then return in 2 weeks, at day 15, and they will be re-assessed. The patients will be dispensed the investigational product and instructed on its daily use. The patients will continue to return every 14 days to have their skin assessed until their final visit on day 99, one week after their 3rd menses on treatment (4th menses on study). The duration of the study per patient is approximately 4 months, and the study team anticipates an enrollment period of 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combo | Experimental | lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel; daily use for 99 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination | Drug | At Day 15, patients will be re-assessed and dispensed the investigational product and instructed on its daily use. Patients will continue to return every 14 days to have their skin assessed until their final visit on day 99, one week after their 3rd menses on treatment (4th menses on study). |
| Measure | Description | Time Frame |
|---|---|---|
| PGA Score | Treatment Success defined as a score of 0 (clear) to 1 (almost clear) at day 99 (final study visit) by acne PGA scoring system. Full PGA scale from 0-5, with lower score indicating better drug efficacy | Day 99 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Severity | Safety/drug-tolerance evaluated by subject-reported adverse events as well as physician evaluated erythema, scaling, drying, and stinging/burning on a 0-3 point scale, where 0=none and 3=severe. | Day 99 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anjali Shroff, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
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Recruitment from July 2015 through August 2019 Please confirm the date of the first enrollment (month, day, year) Please confirm the date of the last study visit or the last date that data was collected (month, day, year)
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combo | lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel; daily use for 99 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combo | lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel; daily use for 99 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | PGA Score | Treatment Success defined as a score of 0 (clear) to 1 (almost clear) at day 99 (final study visit) by acne PGA scoring system. Full PGA scale from 0-5, with lower score indicating better drug efficacy | Posted | Mean | Standard Error | score on a scale | Day 99 |
|
|
99 days
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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 | Lidamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combo | lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel; daily use for 99 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anjali Vekaria | Icahn School of Medicine at Mount Sinai | 212-241-3288 | anjali.shroff@mssm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 22, 2015 | Aug 18, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001585 | Benzoyl Peroxide |
| ID | Term |
|---|---|
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Application of clindamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel to treat perimenstrual acne
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|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| Secondary | Adverse Event Severity | Safety/drug-tolerance evaluated by subject-reported adverse events as well as physician evaluated erythema, scaling, drying, and stinging/burning on a 0-3 point scale, where 0=none and 3=severe. | Posted | Count of Participants | Participants | Day 99 |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
|
| 3 |
|