Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Facies

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Low dose DFD07 once daily

High dose DFD07 once daily

High dose DFD07 twice daily

Placebo twice daily

Srinivas R. Sidgiddi, M.D.

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

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.

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)

Proportion of subjects with partial clearance of AK lesions at week 16 (12 weeks treatment and 4 weeks treatment free follow up period)

Dr. Reddy's Laboratories Limited

DFD07 Cream (Celecoxib 1.25%) Once daily for 12 weeks followed by 4 weeks treatment-free period. In this group active treatment was applied once daily in the evening and Vehicle treatment was applied once daily in the morning for 12 weeks to maintain study blind.

DFD07 Cream (Celecoxib 1.25%) Once Daily

DFD07 Cream (Celecoxib 2.5%) Once daily for 12 weeks followed by 4 weeks treatment-free period. In this group active treatment was applied once daily in the evening and Vehicle treatment was applied once daily in the morning for 12 weeks to maintain study blind.

DFD07 Cream (Celecoxib 2.5%) Once Daily

DFD07 Cream (Celecoxib 2.5%) Twice daily for 12 weeks followed by 4 weeks treatment-free period

DFD07 Cream (Celecoxib 2.5%) Twice Daily

Vehicle Cream (Celecoxib 0%) Twice daily for 12 weeks followed by 4 weeks treatment-free period

Vehicle Cream (Celecoxib 0%) Twice Daily

DFD07 Cream (celecoxib 1.25%) once daily:

The active investigational product was applied once daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. In this group, the randomized active DFD-07 (celecoxib 1.25%) Cream product was applied once daily in the evening, while the Vehicle for DFD-07 Cream was applied once daily in the morning to keep the blinding between groups.

DFD07 Cream 1.25% Once Daily

DFD07 Cream (celecoxib 2.5%) once daily:

The active investigational product was applied once daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. In this group, the randomized active DFD-07 (celecoxib 2.5%) Cream product was applied once daily in the evening, while the Vehicle for DFD-07 Cream was applied once daily in the morning to keep the blinding between groups.

DFD07 Cream 2.5% Once Daily

DFD07 Cream (celecoxib 2.5%) twice daily:

The active investigational product was applied twice daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment.

DFD07 Cream 2.5% Twice Daily

Vehicle Cream (celecoxib 0%) twice daily:

The Vehicle Cream was applied twice daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment.

Vehicle Cream Twice Daily

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Srinivas Sidgiddi

Intent To Treat (ITT) population defined as all subjects who were randomized and dispensed study medication.

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

Proportion of Subjects With Partial Clearance at Week 16

Low dose DFD07 (1.25%) once daily:

The active investigational product was applied once daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. The dose for the study product was a maximum of 0.5 g per application to the entire 5 cm x 5 cm area on the face and/or scalp for a maximum dose of 0.5 g per day. In this group, the randomized active DFD-07 (celecoxib) Cream product was applied once daily in the evening, while the Vehicle for DFD-07 Cream was applied once daily in the morning to keep the blinding between groups.

DFD07 - 1.25% Once Daily

High dose DFD07 (2.5%) once daily:

The active investigational product was applied once daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. The dose for the study product was a maximum of 0.5 g per application to the entire 5 cm x 5 cm area on the face and/or scalp for a maximum dose of 0.5 g per day. In this group, the randomized active DFD-07 (celecoxib) Cream product was applied once daily in the evening, while the Vehicle for DFD-07 Cream was applied once daily in the morning to keep the blinding between groups.

DFD07 - 2.5% Once Daily

High dose DFD07 (2.5%) twice daily: The active investigational product was applied twice daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. The dose for the study product was a maximum of 0.5 g per application to the entire 5 cm x 5 cm area on the face and/or scalp for a maximum dose of 1.0 g per day.

DFD07 - 2.5% Twice Daily

Vehicle twice daily:

The Vehicle product was applied twice daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. The dose for the Vehicle product was a maximum of 0.5 g per application to the entire 5 cm x 5 cm area on the face and/or scalp for a maximum dose of 1.0 g per day.

Spots Global Cancer Trial Database for 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

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