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Label indication ARAZLO ® (tazarotene) lotion, 0.045% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. ARAZLO is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. ( 1 ) FDA label
Also known as Tazarotene (Patch application in Challenge Phase), Tazarotene cream, Tazorac
Tazarotene · 2 trials · 1 indication
Patch site evaluations for signs of inflammatory skin responses and superficial effect
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Tazarotene foam 0.1% |
| 2 | ACTIVE_COMPARATOR | Tazaroc Gel 0.1% |
| Tazarotene Foam without irradiation | EXPERIMENTAL | Subjects will be exposed to Tazarotene Foam Patch without irradiation |
| Tazarotene Foam with UVA and UVB irradiation | EXPERIMENTAL | Subjects will be exposed to Tazarotene Foam Patch with UVA and UVB irradiation |
| Tazarotene Foam & UVA/UVB/visible light | EXPERIMENTAL | Subjects will be exposed to Tazarotene Foam Patch with UVA and UVB and visible light irradiation |
| Vehicle Foam without irradiation, | PLACEBO_COMPARATOR | Subjects will be exposed to Vehicle Foam Patch without irradiation |
| Vehicle Foam with UVA and UVB irradiation | PLACEBO_COMPARATOR | Subjects will be exposed to Vehicle Foam Patch with UVA and UVB irradiation |
| Vehicle Foam with UVA & UVB visible light irradiation | PLACEBO_COMPARATOR | Subjects will be exposed to Vehicle Foam Patch with UVA and UVB and visible light irradiation |
| Blank patch without irradiation | SHAM_COMPARATOR | Subjects will be exposed to blank patch without irradiation, |
| Blank patch with UVA and UVB irradiation | SHAM_COMPARATOR | Subjects will be exposed to blank patch with UVA and UVB irradiation |
| Blank Patch with UVA & UVB visible light irradiation | SHAM_COMPARATOR | Subjects will be exposed to Blank Patch with UVA and UVB and visible light irradiation |
| Name | Type | Description |
|---|---|---|
| Tazarotene | DRUG | Topical Tazarotene foam applied daily for 22 days. |
| Tazaroc Gel | DRUG | Topical tazarotene gel applied daily for 22 days. |
| Tazarotene (Patch application in Challenge Phase) | DRUG | There are 2 phases in this study. The induction phase will include 6 days of patch application to the subject's back. Patches will be removed daily and irradiated. Patch applications will be placed on the same sites, unless a strong reaction is observed. The induction phase will be followed by a rest period followed by the Challenge Phase which consists of a 24-hr application of 3 sets of 3 patches (Set C, Set D, and Set E) applied to naïve sites on the subject's back. Each set of patches will consist of a tazarotene foam patch, a vehicle foam patch, and a blank patch. After 24 hrs, Set D patch sites will be evaluated and irradiated with UVA/UVB light. Set C patch sites will be evaluated and irradiated with UVA, UVB light and visible light. Set E patch sites will be evaluated \& will serve as nonirradiated controls. Patch sites will be evaluated 1 hr after patch removal and during follow up visits at 24 hrs, 48 hrs, and 72 hrs after removal of the final patch in Set E. |
Inclusion Criteria: * Male or female 12 years of age or older who is in good general health. * Have an Investigator's Static Global Assessment (ISGA) score of 3 or greater at baseline. The area considered for the ISGA must be confined to the face. * Regular menstrual cycle prior to study entry (as ...
Tazarotene is a small molecule being studied for the treatment of Acne Vulgaris. It is in Phase 1 clinical development under GSK plc. The two completed Phase 1 trials enrolled a total of 89 participants with Acne Vulgaris or healthy volunteers, evaluating topical foam formulations of the drug.
Tazarotene targets the retinoic acid receptors RARG, RARB, and RARA, where it acts as an agonist. By binding and activating these receptors, it modulates retinoid signaling pathways involved in skin cell turnover and differentiation, which is the basis for its investigation in Acne Vulgaris.
GSK plc, which trades under the ticker GSK, is the developer of Tazarotene for Acne Vulgaris. The company has sponsored the Phase 1 clinical program evaluating topical tazarotene foam formulations in participants with acne and in healthy volunteers.
Tazarotene is in Phase 1 clinical development for Acne Vulgaris. Both of its Phase 1 trials are completed, and no active trials are currently listed. It is an investigational product and has not been approved for this use based on the available development information.
Tazarotene has been studied in two completed Phase 1 trials. NCT01119651 evaluated whether tazarotene foam could cause an allergic reaction when applied to skin and exposed to light in 59 healthy volunteers. NCT01019603 compared the bioavailability of tazarotene foam 0.1% with Tazorac gel 0.1% in 30 subjects with Acne Vulgaris.
Tazarotene is also referred to as Tazarotene cream and as Tazarotene patch application in Challenge Phase. Tazorac gel is a separate comparator formulation that appeared in the bioavailability trial NCT01019603, where tazarotene foam 0.1% was compared against Tazorac gel 0.1% in subjects with Acne Vulgaris.