Conditions: Actinic Keratosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 476
Healthy volunteers: no

Brief summary:
To compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3% (Actavis) to the marketed formulation Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms) in the treatment of the actinic keratosis

Detailed description:

Arms:
arm 1: The diclofenac sodium 3% test gel is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Test Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site. arm 2: The Reference diclofenac sodium 3% gel (Solaraze®) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Reference (Solaraze®) Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site. arm 3: The placebo gel (contains no active ingredient) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough placebo gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.

Interventions: intervention 1: Diclofenac sodium intervention 2: Placebo
Intervention descriptions: intervention 1: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days. intervention 2: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.

Protocol document: