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

Actinic Keratosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01962987
• Other study ID #: 71204901
• Status: Completed
• Phase: Phase 3
• Start date: March 2013
• Est. completion date: September 2013

Study information

• Verified date: July 2020
• Source: Actavis Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 476
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Signed informed consent form, which meets all criteria of current FDA and HIPAA regulations.

2. Immunocompetent male or non-pregnant, non-lactating female at least 18 years of age.

3. Diagnosis of AK with = 5 and < 10 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions each at least 4 mm in diameter on the face and/or bald scalp contained within a 25cm2 treatment area.

4. Women either must be 1 year post-menopausal (no menstrual periods for at least 12 months), surgically sterile, or if they are of child-bearing potential, they must:

1. Have been using systemic birth control, IUD, or Norplant for at least 28 days prior to the start of treatment period of the study, or used barrier methods such as diaphragm plus spermicide or condom plus spermicide consistently, at least 14 days before study gel administration.

2. Had a normal menstrual cycle for the month prior to the start of treatment.

3. Have a negative urine pregnancy test result upon entry into the study.

4. Agree to use a medically accepted form of birth control (oral, implant, injectable or transdermal contraceptives, intrauterine device, condom plus spermicide, diaphragm plus spermicide) or practice abstinence throughout the study period.

5. Free from any systemic or dermatologic disorder that, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs.

6. Any skin type or race, providing the skin pigmentation will allow discernment of erythema.

7. Willingness and capability to cooperate to the extent and degree required by the protocol.

Exclusion Criteria:

1. Active gastrointestinal ulceration or bleeding.

2. Current or history of severe renal or hepatic impairment.

3. Presence of atopic dermatitis, basal cell carcinoma, squamous cell carcinoma, eczema, psoriasis, rosacea, sunburn or other possible skin conditions on the face or bald scalp that in the investigator's opinion would interfere with the study assessments.

4. Use within six months prior to randomization of oral isotretinoin.

5. Use within six months prior to randomization on the face or bald scalp of 1) chemical peel, 2) dermabrasion, 3) laser abrasion, 4) PUVA (psoralen plus ultraviolet A) therapy, or 5) UVB therapy

6. Use within one month prior to randomization on the face or bald scalp of 1) cryodestruction or chemodestruction, 2)curettage, 3) photodynamic therapy, 4) surgical excision, 5)topical 5-fluorouracil, 6) topical corticosteroids, 7) topical diclofenac, 8) topical Imiquimod, 9) topical retinoids, or 10) other treatments for actinic keratosis including glycolic acids or over-the-counter products containing retinol, alpha or beta hydroxy acids.

7. Use within one month prior to randomization of 1)immunomodulators or immunosuppressive therapies, 2)interferon, 3) systemic corticosteroids or 4) cytotoxic drugs. (The occasional use of ophthalmic, nasal or inhaled steroids is acceptable and not reason for exclusion)

8. Known allergies to diclofenac sodium, benzyl alcohol, polyethylene glycol monomethyl ether 359, hyaluronate sodium or any excipients in the test or reference gels.

9. Receiving 5-Fluorouracil or other systemic cancer chemotherapy within 6 months prior to randomization.

10. Any condition, medical, psychological, or social, that, in the Investigator's opinion, would interfere with participation in the study.

11. Women who are pregnant, planning pregnancy or lactating.

12. Participation in any investigational drug study within 30 days of randomization or previous participation in this study.

13. Employees of the research center or Investigator.

14. Family members of employees of the research center or Investigator.

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Diclofenac sodium
Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.

Other:
• Placebo
Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.

Locations

Country	Name	City	State
United States	Investigator Site 8	Arlington Heights	Illinois
United States	Investigator Site 22	Atlanta	Georgia
United States	Investigator Site 11	Boise	Idaho
United States	Investigator Site 13	Bozeman	Montana
United States	Investigator Site 21	Brandon	Florida
United States	Investigator Site 30	Cincinnati	Ohio
United States	Investigator Site 5	Clinton	South Carolina
United States	Investigator Site 14	Denver	Colorado
United States	Investigator Site 17	Denver	Colorado
United States	Investigator Site 25	Dunedin	Florida
United States	Investigator Site 20	Fort Myers	Florida
United States	Investigator Site 23	Fremont	California
United States	Investigator Site 27	Fridley	Minnesota
United States	Investigator Site 1	Hazleton	Pennsylvania
United States	Investigator Site 15	Jacksonville	Florida
United States	Investigator Site 4	Johnson City	Tennessee
United States	Investigator Site 9	Long Beach	California
United States	Investigator Site 31	Louisville	Kentucky
United States	Investigator Site 16	Miami	Florida
United States	Investigator Site 29	Midlothian	Virginia
United States	Investigator Site 10	Nashville	Tennessee
United States	Investigator Site 26	New Bern	North Carolina
United States	Investigator Site 12	Newport Beach	California
United States	Investigator Site 6	Ormond Beach	Florida
United States	Investigator Site 28	Plainfield	Indiana
United States	Investigator Site 3	Raleigh	North Carolina
United States	Investigator Site 2	San Diego	California
United States	Investigator Site 24	San Ramon	California
United States	Investigator Site 7	West Jordan	Utah
United States	Investigator Site 18	Wilmington	North Carolina
United States	Investigator Site 19	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Actavis Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With 100% Clearance of All AK Lesions Within the Treatment Area Assessed at Day 90	The primary measure of bioequivalence will be evaluated using those patients who complete the study according to the (PP) population.	90 days