A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® Gel 3% in the Treatment of Actinic Keratosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01742663
First received: December 3, 2012
Last updated: January 19, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Actinic Keratosis
Drug: Diclofenac Sodium Gel 3%
Drug: Solaraze® (diclofenac sodium) Gel 3%
Drug: Vehicle Topical Gel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Taro Pharmaceuticals USA:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: Study day 90 (30 days after completion of 60 days of treatment) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Superiority to placebo [ Time Frame: Study day 90 (30 days after completion of 60 days of treatment) ] [ Designated as safety issue: No ]
    The superiority of the test and reference gels against the placebo will be tested by the proportion of patients showing 100% clearance of actinic keratosis lesions at Day 90 (30 days after completion of 60 days of treatment)using the modified intent to treat population and last observation carried forward.


Enrollment: 435
Study Start Date: October 2012
Study Completion Date: October 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diclofenac Sodium Gel 3%
Diclofenac Sodium Gel 3% (Taro Pharmaceuticals Inc.)
Drug: Diclofenac Sodium Gel 3%
Diclofenac Sodium Gel 3% (Taro Pharmaceuticals Inc.) applied twice daily for 60 days.
Active Comparator: Solaraze® (diclofenac sodium) Gel 3%
Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms)
Drug: Solaraze® (diclofenac sodium) Gel 3%
Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms)applied twice daily for 60 days.
Placebo Comparator: Vehicle Topical Gel
Vehicle Topical Gel (Taro Pharmaceuticals Inc.)
Drug: Vehicle Topical Gel
Vehicle Topical Gel (Taro Pharmaceuticals Inc.) applied twice daily for 60 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • Women who are pregnant or planning pregnancy or lactating during the study.
  • Participation in any investigational drug study within 30 days of enrollment or previous participation in this study.
  • Employees or family members of employees of the research center or investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT01742663     History of Changes
Other Study ID Numbers: DCSG 1213
Study First Received: December 3, 2012
Last Updated: January 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Taro Pharmaceuticals USA:
Diclofenac Sodium Gel 3%
Solaraze® (diclofenac sodium) Gel 3%
Actinic Keratosis

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014