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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

NCT03116698 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2019-04-24

Study results available
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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

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

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Srinivas R. Sidgiddi, M.D. · Dr. Reddy's Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-14
Primary Completion
2017-11-13
Completion
2018-07-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03116698 on ClinicalTrials.gov