Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Adapalene
Differin · 1 trial · 1 indication
Per Protocol Population (PPP) was assessed for the mean percent reduction compared to baseline in non-nodular lesion count (papules and pustules) at Day 84. If a patient was withdrawn from the study prior to Day 84 for lack of efficacy, then their data was carried forward for this analysis.
Per Protocol Population (PPP) was assessed for the mean percent reduction in non-inflamed lesion count (open and closed comedones) compared with baseline at Day 84. If a patient was withdrawn from the study prior to Day 84 for lack of efficacy, then their data was carried forward for this analysis.
All 601 patients randomized and dispensed study drug were included in the safety analysis. The frequency, severity, and relationship to the study drug for adverse events in each treatment group were used to compare the safety of the study medications.
| Arm | Type | Description |
|---|---|---|
| Investigational Test Product | EXPERIMENTAL | Adapalene Topical Gel, 0.1% |
| Reference Listed Drug | ACTIVE_COMPARATOR | Differin® (adapalene 0.1%) Topical Gel |
| Placebo | PLACEBO_COMPARATOR | Gel base only |
| Name | Type | Description |
|---|---|---|
| Adapalene | DRUG | 0.1% Topical Gel |
| Differin® | DRUG | 0.1% Topical Gel |
| Placebo | DRUG | Gel Base |
Inclusion Criteria: * Male or non-pregnant, non-lactating female, 12-40 years of age inclusive. * Signed informed consent form, which meets all the criteria of the current FDA regulations. For patients under the age of majority in the state they are enrolled, the patient's parent or legal guardian ...
Differin is used for the treatment of acne vulgaris, a common skin condition. It is a small molecule dermatology therapy developed by Teva Pharmaceutical Industries Limited. The clinical program for Differin in acne vulgaris includes one completed Phase 1 trial with 601 enrolled patients.
Differin is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company sponsored the clinical development program for Differin in acne vulgaris, including a completed Phase 1 bioequivalence trial conducted in the United States and Belize.
Differin is in Phase 1 clinical development for acne vulgaris. One Phase 1 trial has been completed, and no trials are currently active. The completed study was a randomized, double-blind, placebo-controlled bioequivalence trial that enrolled 601 patients aged 12 years and older.
Differin has been studied in the Phase 1 trial NCT01182636, titled Bioequivalence of Adapalene Topical Gel in Patients With Acne Vulgaris. The trial was completed, enrolled 601 participants, and was conducted in the United States and Belize. It was randomized, double-blind, and placebo-controlled.
Yes, Differin and Differin® refer to the same product. Differin® is the registered brand name, while Differin is the common written form. Both names refer to the small molecule acne vulgaris therapy developed by Teva Pharmaceutical Industries Limited for the treatment of acne vulgaris.
Differin is an investigational therapy in clinical development for acne vulgaris, with one completed Phase 1 trial. The available development information covers its Phase 1 bioequivalence study in patients with acne vulgaris, and no approval status is stated for this program.