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ACT01

Phase 2

Actinic Keratosis | Small molecule | Dermatology |Dr. Reddy's Laboratories Ltd|Last Updated: Feb 22, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

ACT01 · 1 trial · 1 indication

Phase 2 1
NCT02126670ACT01 in Combination With Comp01-04 in Patients With Actinic KeratosisActinic Keratosis
COMPLETED100 Analytics
PHASE2COMPLETED
ACT01 in Combination With Comp01-04 in Patients With Actinic Keratosis
Actinic KeratosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Treatment Success at End of Study Visit
up to Day 57

Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions

Secondary Endpoints

Irritation Score
up to Day 57
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ACT01 plus Comp01PLACEBO_COMPARATORACT01 Cream in combination with Comp01 Cream, once daily, 29 days
ACT01 plus Comp02ACTIVE_COMPARATORACT01 Cream in combination with Comp02 Cream, once daily, 29 days
ACT01 plus Comp03ACTIVE_COMPARATORACT01 Cream in combination with Comp03 Cream, once daily, 29 days
ACT01 plus Comp04OTHERACT01 Cream in combination with Comp04 Cream, once daily, 29 days

Interventions

NameTypeDescription
ACT01DRUG -
Comp01DRUG -
Comp02DRUG -
Comp03DRUG -
Comp04DRUG -
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Eligibility Criteria

Age Range30 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites4

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...

Countries:United States
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Frequently asked questions about ACT01

What is ACT01 used for?

ACT01 is an investigational small molecule being developed for the treatment of actinic keratosis, a skin condition characterized by rough, scaly patches on the skin caused by sun damage. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes ACT01?

ACT01 is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker symbol RDY. The company is conducting clinical trials to evaluate the safety and efficacy of ACT01 in patients with actinic keratosis.

What phase is ACT01 in?

ACT01 is currently in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational, meaning it has not been approved for commercial use. Further clinical studies may be required to establish its safety and effectiveness.

What clinical trials is ACT01 in?

ACT01 has been studied in one completed Phase 2 clinical trial with the identifier NCT02126670. This trial evaluated ACT01 in combination with Comp01-04 in patients with actinic keratosis and enrolled 100 participants in the United States. The trial was placebo-controlled and randomized.

Is ACT01 the same as Comp01-04?

No, ACT01 and Comp01-04 are distinct agents. In the clinical trial NCT02126670, ACT01 was studied in combination with Comp01-04, indicating that they are separate drugs used together in the treatment of actinic keratosis.