A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis
NCT ID: NCT01962987
Last Updated: 2020-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
476 participants
INTERVENTIONAL
2013-03-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Diclofenac Sodium 3% gel - Test
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.
Diclofenac sodium
Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
Diclofenac Sodium 3% gel - Reference
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.
Diclofenac sodium
Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
Placebo gel
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.
Placebo
Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
Interventions
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Diclofenac sodium
Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
Placebo
Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Actavis Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Henry Lau, PhD
Role: STUDY_DIRECTOR
Actavis Inc.
Locations
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Investigator Site 23
Fremont, California, United States
Investigator Site 9
Long Beach, California, United States
Investigator Site 12
Newport Beach, California, United States
Investigator Site 2
San Diego, California, United States
Investigator Site 24
San Ramon, California, United States
Investigator Site 14
Denver, Colorado, United States
Investigator Site 17
Denver, Colorado, United States
Investigator Site 21
Brandon, Florida, United States
Investigator Site 25
Dunedin, Florida, United States
Investigator Site 20
Fort Myers, Florida, United States
Investigator Site 15
Jacksonville, Florida, United States
Investigator Site 16
Miami, Florida, United States
Investigator Site 6
Ormond Beach, Florida, United States
Investigator Site 19
Winter Park, Florida, United States
Investigator Site 22
Atlanta, Georgia, United States
Investigator Site 11
Boise, Idaho, United States
Investigator Site 8
Arlington Heights, Illinois, United States
Investigator Site 28
Plainfield, Indiana, United States
Investigator Site 31
Louisville, Kentucky, United States
Investigator Site 27
Fridley, Minnesota, United States
Investigator Site 13
Bozeman, Montana, United States
Investigator Site 26
New Bern, North Carolina, United States
Investigator Site 3
Raleigh, North Carolina, United States
Investigator Site 18
Wilmington, North Carolina, United States
Investigator Site 30
Cincinnati, Ohio, United States
Investigator Site 1
Hazleton, Pennsylvania, United States
Investigator Site 5
Clinton, South Carolina, United States
Investigator Site 4
Johnson City, Tennessee, United States
Investigator Site 10
Nashville, Tennessee, United States
Investigator Site 7
West Jordan, Utah, United States
Investigator Site 29
Midlothian, Virginia, United States
Countries
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Other Identifiers
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71204901
Identifier Type: -
Identifier Source: org_study_id
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