Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01017120 | A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne | PHASE3 | COMPLETED | 742 | — | — | Oct 1, 2009 | Nov 9, 2010 | May 18, 2017 | 18 | United States, Canada |
| NCT01017146 | A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne - W0260-301 | PHASE3 | COMPLETED | 744 | — | — | Oct 1, 2009 | Nov 1, 2010 | Jan 18, 2017 | 22 | United States, Canada |
| NCT01114841 | A Study To Evaluate The Contact Sensitization Potential Of Tazarotene Foam On Skin In Healthy Volunteers | PHASE1 | COMPLETED | 254 | — | — | Mar 31, 2010 | Jun 26, 2010 | Jun 14, 2017 | 1 | United States |
| NCT01112787 | A Study to Evaluate the Irritation Potential of Tazarotene Foam on Skin in Healthy Volunteers | PHASE1 | COMPLETED | 39 | — | — | Mar 26, 2010 | Apr 26, 2010 | Jun 20, 2017 | 1 | United States |
LC: count of all inflammatory lesions (ILs, i.e., papules, pustules, and nodules) and non-inflammatory lesions (NILs, i.e., open and closed comedones) at Baseline and at Week 12. Total lesions (TLs) were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline.
Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: \>G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions \[NLs\]); 3=moderate S: \>G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: \>G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions \[NLs\]); 3=moderate S: \>G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
Patch sites will be evaluated for signs of inflammatory skin responses (e.g. erythema, edema, papules) and superficial effects
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Tazarotene foam, 0.1% |
| 2 | PLACEBO_COMPARATOR | Vehicle Foam |
| Tazarotene Foam | EXPERIMENTAL | Subjects will be exposed to patches containing Tazarotene foam 0.1% |
| Vehicle Foam | PLACEBO_COMPARATOR | Subjects will be exposed to patches containing Vehicle Foam |
| Sodium Laural Sulfate | ACTIVE_COMPARATOR | Subjects will be exposed to patches containing Sodium Laural Sulfate. |
| Distilled Water | PLACEBO_COMPARATOR | Subjects will be exposed to patches containing Distilled Water. |
| Name | Type | Description |
|---|---|---|
| Tazarotene Foam | DRUG | Tazarotene foam once a day application to the face |
| Vehicle Foam | DRUG | Vehicle Foam once a day application to the face |
| Sodium Laural Sulfate | DRUG | Sodium Laural Sulfate |
| Distilled Water | DRUG | Distilled Water |
Inclusion Criteria: * Male or female age 12 through 45 years, inclusive, who is in good general health. * An ISGA score of 3 or greater at baseline. * Lesion counts meeting both of the following criteria: 1. Between 25 and 50 facial inflammatory lesions and no more than 1 facial nodular lesion (...