Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Adapalene · 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 If a patient was withdrawn from the study prior to Day 84 for lack of efficacy, then their data was carried forward for this analysis.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 If a patient was withdrawn from the study prior to Day 84 for lack of efficacy, then their data was carried forward for this analysis.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 ...
Adapalene is used for the treatment of acne vulgaris. It is a small molecule being developed by Teva Pharmaceutical Industries Limited (TEVA) as a topical gel. The drug is currently in Phase 1 clinical development for this dermatological condition.
Adapalene is a retinoid-like compound that works by modulating cellular differentiation and proliferation in the skin. It is applied topically to treat acne vulgaris by normalizing the shedding of skin cells and reducing inflammation in the affected areas.
Adapalene is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. The drug is formulated as a topical gel for the treatment of acne vulgaris.
Adapalene is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for its safety and bioequivalence in patients with acne vulgaris.
Adapalene has been studied in a Phase 1 clinical trial with the identifier NCT01182636. This trial, titled "Bioequivalence of Adapalene Topical Gel in Patients With Acne Vulgaris," was a randomized, double-blind, placebo-controlled study that enrolled 601 participants in the United States and Belize.
Adapalene is the generic name of a topical retinoid that is also known by the brand name Differin. The drug is used to treat acne vulgaris and is available as a gel formulation. It is currently being studied in Phase 1 clinical trials by Teva Pharmaceutical Industries.