A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design Study Comparing Diclofenac Sodium Gel 3% (Taro Pharmaceuticals Inc.) to Solaraze® (Diclofenac Sodium) Gel 3% (Fougera Pharms) in the Treatment of Actinic Keratosis.

Taro Pharmaceuticals USA0 sites435 target enrollmentOctober 2012

ConditionsActinic Keratosis

InterventionsDiclofenac Sodium Gel 3%Solaraze® (diclofenac sodium) Gel 3%Vehicle Topical Gel

DrugsDiclofenac Sodium Gel 3%Solaraze® (diclofenac sodium) Gel 3%Vehicle Topical Gel

Overview

Phase: Phase 1
Intervention: Diclofenac Sodium Gel 3%
Conditions: Actinic Keratosis
Sponsor: Taro Pharmaceuticals USA
Enrollment: 435
Primary Endpoint: Bioequivalence
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The objective of this study is to compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3% (Taro Pharmaceuticals Inc.) to the marketed formulation Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms) in the treatment of actinic keratosis.

Both the test and reference formulations will also be compared to a placebo formulation to test for superiority.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

October 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Taro Pharmaceuticals USA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed informed consent form.
•Immunocompetent male or non-pregnant, non-lactating female at least 18 years of age.
•Diagnosis of AK with at least 5 and no more than 10 clinically typical, visable, discrete, nonhyperkeratotic, nonhypertrophic AK lesions each at least 4 mm in diameter on the face and/or bald scalp contained within a 25 cm2 treatment area.
•Women either must be 1 year post-menopausal, surgically sterile, or if they are of child-bearing potential they must have been using systemic birth control, IUD or Norplant for at least 28 days prior to treatment start, or used barrier methods consistently at least 14 days before study gel administration, had a normal menstrual cycle for the month prior to the start of treatment, have a negative urine pregnancy test result upon entry into the study and agree to use a medically accepted form of birth control throughout the study period.
•Free from any systemic or dermatologic disorder that, in the opinion of the investigator, will interfere with the study results or increase the risks of AEs.
•Any skin type or race, providing the skin pigmentation will allow discernment of erythema.
•Willingness and capability to cooperate to the extent and degree required by the protocol.

Exclusion Criteria

•Active gastrointestinal ulceration or bleeding.
•Current or history of severe renal or hepatic impairment.
•Presence of atopic dermatitis, basal cell carcinoma, squamous cell carcinoma, eczema, psoriasis, rosacea, sunburn or other possible confounding skin conditions on the face or bald scalp.
•Use within six months prior to randomization of oral isotretinoin.
•Use within six months prior to baseline on the face or bald scalp of chemical peel, dermabrasion, laser abrasion, PUVA therapy or UVB therapy.
•Use within one month prior to baseline on the face or bald scalp of cryodestruction or chemodestruction, curettage, photodynamic therapy, surgical excision, topical 5-fluorouracil, topical corticosteroids, topical diclofenac, topical Imiquimod, topical retinoids or other treatments for actinic keratosis including glycolic acids or over-the-counter products containing retinol, alpha or beta hydroxy acids.
•Use within one month prior to baseline of immunomodulators or immunosuppressive therapies, interferon, systemic corticosteroids or cytotoxic drugs.
•Known allergies to diclofenac sodium, benzyl alcohol, polyethylene glycol monomethyl ether 359, hyaluronate sodium or any excipients in the test or reference gels.
•Receiving 5-Fluorouracil or other systemic cancer chemotherapy within 6 months prior to study entry.
•Any condition, medical, psychological or social, that, in the investigator's opinion, would interfere with participation in the study.

Arms & Interventions

Diclofenac Sodium Gel 3%

Diclofenac Sodium Gel 3% (Taro Pharmaceuticals Inc.)

Intervention: Diclofenac Sodium Gel 3%

Solaraze® (diclofenac sodium) Gel 3%

Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms)

Intervention: Solaraze® (diclofenac sodium) Gel 3%

Vehicle Topical Gel

Vehicle Topical Gel (Taro Pharmaceuticals Inc.)

Intervention: Vehicle Topical Gel

Outcomes

Primary Outcomes

Bioequivalence

Time Frame: Study day 90 (30 days after completion of 60 days of treatment)

Bioequivalence will be determined by evaluating the proportion of patients in the test and reference groups with 100% clearance of all AK lesions in the treatment area.