Clinical trial NCT01962987: A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Lead sponsor: Actavis Inc.
Sponsor class: INDUSTRY
First posted: 2013-10-16
Enrollment: 476
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Patients With 100% Clearance of All AK Lesions Within the Treatment Area Assessed at Day 90
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Investigator Site 23
state: California
city: Long Beach
country: United States
facility: Investigator Site 9
state: California
city: Newport Beach
country: United States
facility: Investigator Site 12
state: California
city: San Diego
country: United States
facility: Investigator Site 2
state: California
city: San Ramon
country: United States
facility: Investigator Site 24
state: California
city: Denver
country: United States
facility: Investigator Site 14
state: Colorado
city: Denver
country: United States
facility: Investigator Site 17
state: Colorado
city: Brandon
country: United States
facility: Investigator Site 21
state: Florida
city: Dunedin
country: United States
facility: Investigator Site 25
state: Florida
city: Fort Myers
country: United States
facility: Investigator Site 20
state: Florida
city: Jacksonville
country: United States
facility: Investigator Site 15
state: Florida
city: Miami
country: United States
facility: Investigator Site 16
state: Florida
city: Ormond Beach
country: United States
facility: Investigator Site 6
state: Florida
city: Winter Park
country: United States
facility: Investigator Site 19
state: Florida
city: Atlanta
country: United States
facility: Investigator Site 22
state: Georgia
city: Boise
country: United States
facility: Investigator Site 11
state: Idaho
city: Arlington Heights
country: United States
facility: Investigator Site 8
state: Illinois
city: Plainfield
country: United States
facility: Investigator Site 28
state: Indiana
city: Louisville
country: United States
facility: Investigator Site 31
state: Kentucky
city: Fridley
country: United States
facility: Investigator Site 27
state: Minnesota
city: Bozeman
country: United States
facility: Investigator Site 13
state: Montana
city: New Bern
country: United States
facility: Investigator Site 26
state: North Carolina
city: Raleigh
country: United States
facility: Investigator Site 3
state: North Carolina
city: Wilmington
country: United States
facility: Investigator Site 18
state: North Carolina
city: Cincinnati
country: United States
facility: Investigator Site 30
state: Ohio
city: Hazleton
country: United States
facility: Investigator Site 1
state: Pennsylvania
city: Clinton
country: United States
facility: Investigator Site 5
state: South Carolina
city: Johnson City
country: United States
facility: Investigator Site 4
state: Tennessee
city: Nashville
country: United States
facility: Investigator Site 10
state: Tennessee
city: West Jordan
country: United States
facility: Investigator Site 7
state: Utah
city: Midlothian
country: United States
facility: Investigator Site 29
state: Virginia
Study officials:
affiliation: Actavis Inc.
name: Henry Lau, PhD
role: STUDY_DIRECTOR
References: