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The primary objective of this study is to compare the efficacy, safety and tolerability of IDP-121 Lotion and vehicle in the treatment of subjects with acne vulgaris.
This is a multicenter, randomized, double-blind, parallel group, vehicle-controlled, 12-week study to evaluate relative changes in inflammatory and non-inflammatory lesion counts, as well as treatment success using an Evaluator's Global Severity Scale (EGSS) in subjects with moderate to severe acne. IDP-121 is a lotion for the topical treatment of acne.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDP-121 Lotion | Experimental | IDP-121 Lotion, applied topically to the face, once daily for 12 weeks. |
|
| IDP-121 Lotion Vehicle | Placebo Comparator | IDP-121 Vehicle Lotion, applied topically to the face, once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDP-121 Lotion | Drug | Investigational Product: IDP-121 Lotion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in inflammatory lesion count from baseline to Week 12 | 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 in non-inflammatory lesion count from baseline to Week 12 | 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 |
| Proportion of subjects who have a least a 2 grade reduction at Week 12 from baseline in the Evaluator's Global Severity Score and were Clear or Almost Clear | 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 |
|---|---|---|
| Percent change in inflammatory lesion count from baseline to Week 4, 8, and 12 | At each visit the Evaluator will count the total number of inflammatory lesions (papules, pustules, and nodules) on the subject's face, and the percent change will be calculated. | 4, 8, and 12 weeks |
| Percent change in non-inflammatory lesion count from baseline to Week 4, 8, and 12 |
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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-121 Vehicle Lotion |
| Drug |
Comparator Product: IDP-121 Vehicle Lotion |
|
| 12 weeks |
At each visit the Evaluator will count the total number of non-inflammatory lesions (open and closed comedones), and the percent change will be calculated. |
| 4, 8, and 12 weeks |
| Proportion of subjects who have a least a 2 grade reduction at Week 4, 8, and 12 from baseline 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
| 4, 8, and 12 weeks |