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The primary objective of this study is to compare the safety and efficacy of once daily application of IDP-123 Lotion to Tazorac Cream, 0.1%, Vehicle Lotion, and Vehicle Cream 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-123 Lotion in comparison with Tazorac Cream, Vehicle Lotion, and Vehicle Cream in subjects with moderate to severe acne. Treatment success will be evaluated by changes in inflammatory and non-inflammatory lesion counts, as well as treatment success using an Evaluator's Global Severity Score. IDP-123 is a lotion for the topical treatment of acne.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDP-123 Lotion | Experimental | IDP-123 Lotion, applied topically to the face, once daily for 12 weeks. |
|
| Tazorac Cream, 0.1% | Active Comparator | Tazorac Cream (tazarotene 0.1%), applied topically to the face, once daily for 12 weeks. |
|
| Vehicle Cream | Placebo Comparator | Vehicle Cream, applied topically to the face, once daily for 12 weeks. |
|
| Vehicle Lotion | Placebo Comparator | Vehicle Lotion, applied topically to the face, once daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDP-123 Lotion | Drug | Investigational Product: IDP-123 Lotion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in mean inflammatory lesion counts at Week 12 | Facial area lesion counts will be taken from the subject's face by the Evaluator at each visit and the change at week 12 from baseline will be calculated. Facial inflammatory lesions (pustules, papules, and nodules) will be counted as follows: pustules and papules will be counted and recorded together, not separately; nodular lesions will be counted and recorded separately. Inflammatory lesions are defined as follows: Papule - a solid, elevated lesion less than 5 mm; Pustule - an elevated lesion containing pus less than 5 mm; Nodule - palpable subcutaneous lesion greater than 5 mm; has depth, not necessarily elevated | 12 weeks |
| Absolute change in mean non-inflammatory lesion counts at Week 12 | Facial area lesion counts will be taken from the subject's face by the Evaluator at each visit, and the change at week 12 from baseline will be calculated. Non-inflammatory lesions (open and closed comedones) will be counted and recorded together. Non-inflammatory lesions are defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface | 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 |
|---|---|---|
| Mean percent change in inflammatory lesion count from baseline at Weeks 2, 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. | 2, 4, 8, and 12 weeks |
| Mean percent change in non-inflammatory lesion counts from baseline at Weeks 2, 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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| ID | Term |
|---|---|
| C086827 | tazarotene |
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| Tazorac Cream, 0.1%, |
| Drug |
Comparator Product: Tazorac Cream, 0.1% |
|
|
| Vehicle Cream | Drug | Comparator Product: Vehicle Cream |
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| Vehicle Lotion | Drug | Comparator Product: 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. |
| 2, 4, 8, and 12 weeks |
| The proportion of subjects with at least a two grade improvement in the Evaluator's Global Severity Score from baseline at Weeks 2, 4, 8 and 12. | 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, 8, and 12 weeks |