Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tazarotene Foam
Tazarotene Foam with UVA and UVB irradiation · 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 with UVA and UVB irradiation is being studied for the treatment of acne vulgaris, commonly known as facial acne. It is a topical small molecule therapy applied to the skin. The clinical program enrolled 1,779 participants across four completed trials, including two Phase 3 studies in subjects with common facial acne.
Tazarotene Foam with UVA and UVB irradiation is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical trial program evaluating this topical foam formulation for acne vulgaris, including the Phase 3 safety and efficacy studies conducted in the United States and Canada.
Tazarotene Foam with UVA and UVB irradiation has completed Phase 3 clinical development. Two Phase 3 trials, NCT01017146 and NCT01017120, evaluated the safety and efficacy of tazarotene foam 0.1% in subjects with common facial acne. All four registered trials for this asset are listed as completed, with no active trials currently ongoing.
Four completed trials have evaluated Tazarotene Foam with UVA and UVB irradiation. The Phase 3 studies NCT01017146 and NCT01017120 tested tazarotene foam 0.1% in common facial acne, enrolling 744 and 742 participants. Phase 1 studies NCT01114841 and NCT01112787 assessed contact sensitization and skin irritation potential in healthy volunteers.
Yes, Tazarotene Foam with UVA and UVB irradiation is also known as tazarotene foam. The two names refer to the same topical small molecule product developed by GSK for acne vulgaris. Searches for either name point to the same clinical development program, which includes two Phase 3 trials and two Phase 1 trials.
The clinical program for Tazarotene Foam with UVA and UVB irradiation includes randomized, double-blind, placebo-controlled trials. The two Phase 3 studies in acne vulgaris enrolled participants aged 12 years and older across the United States and Canada. Phase 1 studies in healthy volunteers assessed skin irritation and contact sensitization potential.