Therapeutic Equivalence of Diclofenac Sodium Gel 3% vs Solaraze ® in the Treatment of Actinic Keratosis
NCT ID: NCT03826550
Last Updated: 2019-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
655 participants
INTERVENTIONAL
2018-01-12
2018-07-03
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
QUADRUPLE
Study Groups
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Diclofenac Sodium Gel3%
Diclofenac Sodium Gel 3%, dosed twice daily for 60 days.
Diclofenac Sodium Gel
Twice daily for 60 days. Each patient is expected to receive 120 doses
Solaraze
Solaraze Gel dosed twice daily for 60 days.
Solaraze 3% Topical Gel
Twice daily for 60 days. Each patient is expected to receive 120 doses
Placebo
Placebo Gel dosed twice daily for 60 days.
Placebo
Twice daily for 60 days. Each patient is expected to receive 120 doses
Interventions
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Diclofenac Sodium Gel
Twice daily for 60 days. Each patient is expected to receive 120 doses
Solaraze 3% Topical Gel
Twice daily for 60 days. Each patient is expected to receive 120 doses
Placebo
Twice daily for 60 days. Each patient is expected to receive 120 doses
Eligibility Criteria
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Inclusion Criteria
2. Male or non-pregnant, non-lactating female, 18 years of age or older.
3. Diagnosis of AK with at least five and no more than ten clinically typical, visible, discrete, non-hyperkeratotic, non-hypertrophic AK lesions, each at least 4 mm in diameter, contained within a contiguous 25 cm2 treatment area on the face and/or bald scalp.
4. Females of childbearing potential must not be pregnant or lactating at Visit 1 (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 mIU/ mL or equivalent units of human chorionic gonadotropin). Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, intrauterine device, a double-barrier method, oral, transdermal, injected, or implanted non-hormonal or hormonal contraceptive) throughout the study. Female patients using hormonal contraceptives should have been on the same product/dosing regimen for at least 28 days before Visit 1 and should not change this regimen during the study. A sterile sexual partner is not considered an adequate form of birth control.
5. Skin pigmentation that will allow discernment of erythema.
Exclusion Criteria
2. Active gastrointestinal ulceration or bleeding.
3. Current evidence or history of severe renal or hepatic impairment.
4. Known allergy or hypersensitivity to diclofenac, benzyl alcohol, polyethylene glycol monomethyl ether 359, hyaluronate sodium or other excipients in the test, reference or vehicle gel.
5. Known allergy or hypersensitivity to other NSAIDs, including aspirin.
6. Presence of atopic dermatitis, basal cell carcinoma, squamous cell carcinoma, eczema, psoriasis, rosacea, sunburn, exfoliative dermatitis, open or recent skin wounds, active infections or other possible skin conditions on the face or bald scalp that in the Investigator's opinion would interfere with the study assessments or put the patient at risk.
7. Use of oral isotretinoin within six months before randomization.
8. Use within six months before Visit 1 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.
9. Use within one month before Visit 1 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 AK including glycolic acids or over the- counter (OTC) products containing retinol, alpha or beta hydroxy acids. The occasional use of ophthalmic, intranasal or inhaled corticosteroids (e.g., management of allergic conjunctivitis) is acceptable and not reason for exclusion. Use of inhaled corticosteroids for the management of chronic and stable conditions (e.g., persistent asthma and chronic obstructive pulmonary disease \[COPD\]) is acceptable as long as it has been on a stable dose for a minimum of three months before the start of the study and up to 1 mg/day.
10. Use within one month before Visit 1 of 1) immunomodulators or immunosuppressive therapies, 2) interferon, 3) systemic corticosteroids or 4) cytotoxic drugs.
11. Receipt of 5-Fluorouracil or other systemic cancer chemotherapy within 6 months before Visit 1.
12. Any condition, medical, psychological, or social, that, in the Investigator's opinion, would interfere with participation in the study or put the patient at risk.
13. Inability to understand the requirements of the study and the relative information or are unable or not willing to comply with the study protocol.
14. Receipt of any drug as part of a research study within 30 days before Visit 1.
15. Employees of the Investigator or research center or their immediate family members.
16. Patients who have participated in this study previously.
18 Years
ALL
No
Sponsors
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Novum Pharmaceutical Research Services
INDUSTRY
Encube Ethicals Pvt. Ltd.
INDUSTRY
Responsible Party
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Locations
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Dermatology Trial Associates
Bryant, Arkansas, United States
West Coast Research
San Ramon, California, United States
Universal Medical and Research Center, LLC
Coral Gables, Florida, United States
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, United States
Health Awareness, Inc.
Jupiter, Florida, United States
Multi-Speciality Research Associates, Inc.
Lake City, Florida, United States
FXM Research
Miami, Florida, United States
FXM Research Miramar
Miramar, Florida, United States
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, United States
Moore Clinical Research
Tampa, Florida, United States
Forward Clinical Trials
Tampa, Florida, United States
Northwest Clinical Trials
Boise, Idaho, United States
DS Research
New Albany, Indiana, United States
DS Research
Louisville, Kentucky, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
DTRL, Inc.
Henderson, Nevada, United States
Dermatology Consulting Services
High Point, North Carolina, United States
Sterling Research Group
Cincinnati, Ohio, United States
DermDox Centers for Dermatology
Hazleton, Pennsylvania, United States
PEAK Research, LLC
Upper Saint Clair, Pennsylvania, United States
Anderson Dermatology
Anderson, South Carolina, United States
Greenville Dermatology, LLC
Greenville, South Carolina, United States
Sirius Clinical Research, LLC
Austin, Texas, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, United States
Countries
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Other Identifiers
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ENC16102
Identifier Type: -
Identifier Source: org_study_id
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