NCT03116698
Completed
Phase 2
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.
ConditionsActinic Keratosis (AK)
Overview
- Phase
- Phase 2
- Intervention
- Low dose DFD07 once daily
- Conditions
- Actinic Keratosis (AK)
- Sponsor
- Dr. Reddy's Laboratories Limited
- Enrollment
- 240
- Locations
- 20
- Primary Endpoint
- Proportion of Subjects With Complete Clearance of AK Lesions at the End of Study Visit at 16 Weeks
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Once or twice daily 12 week treatment in patients with Actinic Keratosis randomized to treatment in one of four arms.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Low dose DFD07 once daily
Intervention: Low dose DFD07 once daily
High dose DFD07 once daily
Intervention: High dose DFD07 once daily
High dose DFD07 twice daily
Intervention: High dose DFD07 twice daily
Placebo twice daily
Intervention: Placebo twice daily
Outcomes
Primary Outcomes
Proportion of Subjects With Complete Clearance of AK Lesions at the End of Study Visit at 16 Weeks
Time Frame: 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 Outcomes
- Proportion of Subjects With Partial Clearance at Week 16(16 weeks)
Study Sites (20)
Loading locations...
Similar Trials
Active, not recruiting
Not Applicable
New Treatments for Actinic Keratoses of the ScalpPhotodamaged SkinActinic KeratosesNCT05456334Helsinki University Central Hospital120
Terminated
Phase 3
A Study to Assess Recurrence of Actinic Keratosis in Participants Treated With Methyl Aminolevulinate Hydrochloride Cream or Vehicle Cream Who Achieved Complete Response to Treated Lesions in Earlier StudyKeratosis, ActinicNCT04269395Galderma R&D125
Completed
Phase 2
Evaluation of a Topical Treatment for Actinic KeratosisActinic Keratosis of Face and ScalpNCT01921907Assuta Hospital Systems52
Terminated
Phase 4
Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic TherapyActinic KeratosisNCT01203878Tennessee Clinical Research Center21
Unknown
Not Applicable
Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field CancerizationActinic KeratosisNCT03013647University of Sao Paulo General Hospital20