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Therapeutic Equivalence of Diclofenac Sodium Gel 3% vs Solaraze ® in the Treatment of Actinic Keratosis

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ClinicalTrials.gov Identifier: NCT03826550
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
Novum Pharmaceutical Research Services
Information provided by (Responsible Party):
Encube Ethicals Pvt. Ltd.

Brief Summary:
Therapeutic Equivalence of Diclofenac Sodium Gel 3% and Solaraze ®, in the treatment of Actinic Keratosis

Condition or disease Intervention/treatment Phase
Actinic Keratoses Drug: Diclofenac Sodium Gel Drug: Solaraze 3% Topical Gel Other: Placebo Phase 3

Detailed Description:
A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel 3% (Encube Ethicals) Compared to Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharmaceuticals Inc.) in the Treatment of Actinic Keratosis

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 655 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled, three-arm, parallel group, multiple-site bioequivalence study with clinical endpoints.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All study products are blinded and provided to the patients in the same packaging.
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel 3% (Encube Ethicals) Compared to Solaraze® (Diclofenac Sodium) Gel 3% (Fougera Pharmaceuticals Inc.) in the Treatment of Actinic Keratosis
Actual Study Start Date : January 12, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : July 3, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diclofenac Sodium Gel3%
Diclofenac Sodium Gel 3%, dosed twice daily for 60 days.
Drug: Diclofenac Sodium Gel
Twice daily for 60 days. Each patient is expected to receive 120 doses

Active Comparator: Solaraze
Solaraze Gel dosed twice daily for 60 days.
Drug: Solaraze 3% Topical Gel
Twice daily for 60 days. Each patient is expected to receive 120 doses

Placebo Comparator: Placebo
Placebo Gel dosed twice daily for 60 days.
Other: Placebo
Twice daily for 60 days. Each patient is expected to receive 120 doses




Primary Outcome Measures :
  1. proportion of patients in each treatment group with 100% clearance of all AK Lesions [ Time Frame: Day 90 (30 days after completion of a 60 day treatment) ]
  2. Superiority of the test and reference products against the placebo [ Time Frame: Day 90 (30 days after completion of a 60 day treatment) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed Institutional Review Board (IRB)-approved informed consent form that meets all criteria of current Food and Drug Administration regulations.
  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:

  1. Females who are pregnant, lactating or planning to become pregnant during the study period.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826550


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Sponsors and Collaborators
Encube Ethicals Pvt. Ltd.
Novum Pharmaceutical Research Services

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Responsible Party: Encube Ethicals Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT03826550     History of Changes
Other Study ID Numbers: ENC16102
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diclofenac
Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action