NCT03116698

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

A Multi-Center, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study to Evaluate the Dose-Response Relationship of the Efficacy and Safety of Two Concentrations of DFD-07 Cream, in Subjects With Actinic Keratosis (AK) of the Face and/or Scalp Over a 12-week Treatment Period.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Once or twice daily 12 week treatment in patients with Actinic Keratosis randomized to treatment in one of four arms.

Conditions

• Actinic Keratosis (AK)

Interventions

Type	Name	Description
DRUG	Low dose DFD07 once daily	Low dose DFD07 once daily
DRUG	High dose DFD07 once daily	High dose DFD07 once daily
DRUG	High dose DFD07 twice daily	High dose DFD07 twice daily
DRUG	Placebo twice daily	Placebo twice daily

Timeline

• Start date: 2017-02-14
• Primary completion: 2017-11-13
• Completion: 2018-07-05
• First posted: 2017-04-17
• Last updated: 2019-04-24
• Results posted: 2019-04-24

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study