Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tazarotene Foam · 4 trials · 1 indication
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 (...
Tazarotene Foam is a small molecule drug being developed for the treatment of Acne Vulgaris, a common skin condition. It is a topical foam formulation that is currently in Phase 3 clinical development. The drug is intended for use in patients with common facial acne.
Tazarotene Foam is being developed by GSK plc, a global pharmaceutical company. GSK plc is listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the safety and efficacy of this drug for the treatment of Acne Vulgaris.
Tazarotene Foam is currently in Phase 3 clinical development. It has completed four clinical trials, including two Phase 3 efficacy studies and two Phase 1 safety studies. The drug is investigational and has not yet been approved by regulatory authorities for the treatment of Acne Vulgaris.
Tazarotene Foam has completed four clinical trials. The Phase 3 trials are NCT01017120 and NCT01017146, which evaluated the safety and efficacy of the drug in subjects with common facial acne. The Phase 1 trials are NCT01112787 and NCT01114841, which assessed skin irritation and contact sensitization potential in healthy volunteers.
Tazarotene Foam is a specific formulation of the drug tazarotene, delivered as a foam. While the active ingredient is tazarotene, the foam formulation is being studied specifically for the treatment of Acne Vulgaris. The clinical trials listed for Tazarotene Foam are distinct from other tazarotene products.