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

Phase 2

Completed

• Conditions: Actinic Keratosis (AK)
• Interventions: Drug: Low dose DFD07 once daily; Drug: High dose DFD07 once daily; Drug: High dose DFD07 twice daily; Drug: Placebo twice daily

• Registration Number: NCT03116698
• Lead Sponsor: Dr. Reddy's Laboratories Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-14
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-14
• Study First Posted: 2017-04-17
• Primary Completion: 2017-11-13
• Study Completion: 2018-07-05
• Status Verified: 2019-04
• Results First Submitted: 2019-04-02
• Results First Submitted QC: 2019-04-02
• Last Update Submitted: 2019-04-02
• Results First Posted: 2019-04-24
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose DFD07 once daily	Low dose DFD07 once daily	-
High dose DFD07 once daily	High dose DFD07 once daily	-
High dose DFD07 twice daily	High dose DFD07 twice daily	-
Placebo twice daily	Placebo twice daily	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Proportion of Subjects With Partial Clearance at Week 16	16 weeks	Proportion of subjects with partial clearance of AK lesions at week 16 (12 weeks treatment and 4 weeks treatment free follow up period)

Trial Locations

Locations (20)

Investigator Site 18; 🇺🇸 Santa Ana, California, United States

Investigator Site 16; 🇺🇸 Boca Raton, Florida, United States

Investigator Site 11; 🇺🇸 San Antonio, Texas, United States

Investigator Site 2; 🇺🇸 San Antonio, Texas, United States

Investigator Site 9; 🇺🇸 Palm Springs, California, United States

Investigator Site 20; 🇺🇸 Miami Lakes, Florida, United States

Investigator Site 19; 🇺🇸 Miami, Florida, United States

Investigator Site 8; 🇺🇸 Lake City, Florida, United States

Investigator Site 17; 🇺🇸 Ormond Beach, Florida, United States

Investigator Site 3; 🇺🇸 Cerritos, California, United States

Investigator Site 7; 🇺🇸 Miami, Florida, United States

Investigator Site 13; 🇺🇸 Verona, New Jersey, United States

Investigator Site 15; 🇺🇸 Stony Brook, New York, United States

Investigator Site 6; 🇺🇸 West Palm Beach, Florida, United States

Investigator Site 14; 🇺🇸 Fort Washington, Pennsylvania, United States

Investigator Site 10; 🇺🇸 Austin, Texas, United States

Investigator Site 4; 🇺🇸 Houston, Texas, United States

Investigator Site 5; 🇺🇸 Plano, Texas, United States

Investigator Site 12; 🇺🇸 San Antonio, Texas, United States

Investigator Site 1; 🇺🇸 Fremont, California, United States