Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ACT01 · 1 trial · 1 indication
Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions
| Arm | Type | Description |
|---|---|---|
| ACT01 plus Comp01 | PLACEBO_COMPARATOR | ACT01 Cream in combination with Comp01 Cream, once daily, 29 days |
| ACT01 plus Comp02 | ACTIVE_COMPARATOR | ACT01 Cream in combination with Comp02 Cream, once daily, 29 days |
| ACT01 plus Comp03 | ACTIVE_COMPARATOR | ACT01 Cream in combination with Comp03 Cream, once daily, 29 days |
| ACT01 plus Comp04 | OTHER | ACT01 Cream in combination with Comp04 Cream, once daily, 29 days |
| Name | Type | Description |
|---|---|---|
| ACT01 | DRUG | - |
| Comp01 | DRUG | - |
| Comp02 | DRUG | - |
| Comp03 | DRUG | - |
| Comp04 | DRUG | - |
Inclusion Criteria: 1. Presence of actinic keratosis lesions on the face and/or scalp within a 25 cm2 contiguous area containing at least four lesions that are non-hypertrophic and non-hyperkeratotic and not larger than 6 mm in longest diameter. 2. Age 30-85 years, inclusive. 3. Good general health...
ACT01 is being developed for the treatment of actinic keratosis, a skin condition that falls within dermatology. It is a small molecule therapy studied in a Phase 2 clinical trial that enrolled 100 patients with actinic keratosis in the United States.
ACT01 is being developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is the sponsor behind the clinical program evaluating ACT01 in dermatology, specifically for patients with actinic keratosis.
ACT01 is in Phase 2 clinical development. One Phase 2 trial has been completed, and no trials are currently active. The program has not been approved by the FDA and remains investigational for the treatment of actinic keratosis.
ACT01 was evaluated in the Phase 2 trial NCT02126670, titled ACT01 in Combination With Comp01-04 in Patients With Actinic Keratosis. The trial enrolled 100 patients aged 30 years and older in the United States, was randomized and placebo controlled, and has been completed.
Yes. The Phase 2 trial of ACT01, NCT02126670, was placebo controlled and randomized, enrolling 100 patients with actinic keratosis. It was not double blinded, and it accepted participants of all sexes aged 30 years and older in the United States.