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Low dose DFD07 once daily

Phase 2

Actinic Keratosis (AK) | Small molecule | Dermatology |Dr. Reddy's Laboratories Ltd|Last Updated: Apr 24, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment240

FDA Designations

No designations recorded

Clinical trial landscape

Low dose DFD07 once daily · 1 trial · 1 indication

Phase 2 1
NCT03116698A Study to Evaluate Two Concentrations of DFD-07 Cream, in Subjects With Actinic Keratosis (AK) of the Face and/or Scalp Over a 12-week Treatment PeriodActinic Keratosis (AK)
COMPLETED240 Analytics
PHASE2COMPLETED
A Study to Evaluate Two Concentrations of DFD-07 Cream, in Subjects With Actinic Keratosis (AK) of the Face and/or Scalp Over a 12-week Treatment Period
Actinic Keratosis (AK)Unlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of Subjects With Complete Clearance of AK Lesions at the End of Study Visit at 16 Weeks
16 Weeks

The proportion of subjects with complete clearance (absence of clinically visible or palpable AK lesions in the treatment area) of AK lesions at the End of Study Visit at 16 weeks (12 weeks treatment and 4 weeks treatment-free follow-up)

Secondary Endpoints

Proportion of Subjects With Partial Clearance at Week 16
16 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Low dose DFD07 once dailyEXPERIMENTAL -
High dose DFD07 once dailyEXPERIMENTAL -
High dose DFD07 twice dailyEXPERIMENTAL -
Placebo twice dailyPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Low dose DFD07 once dailyDRUGLow dose DFD07 once daily
High dose DFD07 once dailyDRUGHigh dose DFD07 once daily
High dose DFD07 twice dailyDRUGHigh dose DFD07 twice daily
Placebo twice dailyDRUGPlacebo twice daily
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion: 1. Subject understands the study procedures, is willing to comply with the study procedures and required visits, and agrees to participate by giving written informed consent. Subjects with a legal guardian, must have the written informed consent of the legal guardian. 2. Subject (or lega...

Countries:United States
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Frequently asked questions about Low dose DFD07 once daily

What is Low dose DFD07 used for?

Low dose DFD07 is a small molecule being developed by Dr. Reddy's Laboratories Ltd for the treatment of actinic keratosis (AK), a skin condition characterized by rough, scaly patches on the skin caused by sun damage. It is applied as a cream to affected areas of the face and/or scalp.

Who makes Low dose DFD07?

Low dose DFD07 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 this investigational treatment for actinic keratosis.

What phase is Low dose DFD07 in?

Low dose DFD07 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 2 trial has been completed, and the drug is being studied for the treatment of actinic keratosis.

What clinical trials is Low dose DFD07 in?

Low dose DFD07 has been studied in one completed Phase 2 clinical trial, identified as NCT03116698. This randomized, double-blind, placebo-controlled study evaluated two concentrations of DFD-07 cream in 240 subjects with actinic keratosis of the face and/or scalp over a 12-week treatment period in the United States.

Is Low dose DFD07 the same as DFD-07?

Yes, Low dose DFD07 is the same as DFD-07. The drug is referred to by both names in clinical trial documentation. The Phase 2 study NCT03116698 evaluated DFD-07 cream, which is the same investigational treatment being developed for actinic keratosis.