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The primary objective of this study is to compare the efficacy, safety, and tolerability of IDP-120 Gel to IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel in subjects with moderate to severe acne vulgaris.
This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel in comparison with IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel at Weeks 2, 4, 8, and 12 in subjects with moderate to severe acne. IDP-120 is a gel for the topical treatment of acne.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDP-120 Gel | Experimental | IDP-120 Gel, applied topically to the face once daily for 12 weeks. |
|
| IDP-120 Component A | Active Comparator | IDP-120 Component A, applied topically to the face once daily for 12 weeks |
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| IDP-120 Component B | Active Comparator | IDP-120 Component B, applied topically to the face once daily for 12 weeks |
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| IDP-120 Vehicle Gel | Placebo Comparator | IDP-120 Vehicle Gel, applied topically to the face once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDP-120 Gel | Drug | Investigational Product: IDP-120 Gel |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from Baseline to Week 12 in mean inflammatory lesion counts | At each visit the Evaluator will count the total number of inflammatory lesions (papules, pustules, and nodules) on the subject's face. Inflammatory lesions are defined as follows: Papule - a small, solid elevation less than 5 mm in diameter. Most of the lesion is above the surface of the skin. Pustule - a small, circumscribed elevation less than 5 mm in diameter that contains yellow-white exudate. Nodule - a subcutaneous lesion greater than or equal to 5 mm in diameter. | 12 weeks |
| Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts | At each visit the Evaluator will count the total number of non-inflammatory lesions (open and closed comedones). Non-inflammatory lesions are defined as follows: Open comedones (black head) - a lesion in which the follicle opening is widely dilated with the contents protruding out onto the surface of the skin. Closed comedones (white head)- a lesion in which the follicle opening is closed, but the sebaceous gland is enlarged by the pressure of the sebum build up, which in turn causes the skin around the follicle to thin and become elevated with a white appearance. | 12 weeks |
| Percent of subjects who achieve at least a two-grade reduction from baseline and are Clear or Almost Clear at Week 12 in the Evaluator's Global Severity Score. | At each visit the severity will be determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations will be scored on a scale of 0-4 (Evaluator's Global Severity Score), with 0 being clear and 4 being severe. Please see below for complete definitions. 0. Clear - Normal, clear skin with no evidence of acne vulgaris
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in inflammatory and non-inflammatory lesion counts from baseline at Weeks 2, 4, and 8. | At each visit the Evaluator will count the total number of inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on the subject's face, and the change will be calculated. | 2, 4, and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anya Loncaric, MS | Contact | 510-259-5284 | aloncaric@solta.com |
| Name | Affiliation | Role |
|---|---|---|
| Anya Loncaric, MS | Valeant Pharmaceuticals | Study Director |
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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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| IDP-120 Component A |
| Drug |
Comparator Product: IDP-120 Component A |
|
| IDP-120 Component B | Drug | Comparator Product: IDP-120 Component B |
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| IDP-120 Vehicle Gel | Drug | Comparator Product: IDP-120 Vehicle Lotion |
|
| 12 weeks |
| Percent of subjects who achieve at least a two-grade reduction from baseline and are Clear or Almost Clear at Week 2, 4, and 8 in the Evaluator's Global Severity Score |
At each visit the severity will be determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations will be scored on a scale of 0-4 (Evaluator's Global Severity Score), with 0 being clear and 4 being severe. Please see below for complete definitions. 0. Clear - Normal, clear skin with no evidence of acne vulgaris
|
| 2, 4, and 8 weeks |
| Mean percent change in inflammatory and non-inflammatory lesion counts form baseline at Weeks 2, 4, 8, and 12. | At each visit the Evaluator will count the total number of inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on the subject's face, and the percent change will be calculated. | 2, 4, 8, and 12 weeks |