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A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze® Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald Scalp

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ClinicalTrials.gov Identifier: NCT02611804
Recruitment Status : Completed
First Posted : November 23, 2015
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceuticals USA

Brief Summary:
To compare the efficacy and safety profiles of Teva's Diclofenac Sodium Gel, 5% (test product) to Solaraze® (diclofenac sodium) Gel, 3% (reference product) to demonstrate the clinical equivalence and to show that the efficacy of the 2 active formulations is superior to that of vehicle in treating subjects with actinic keratosis (AK) on the face or bald scalp.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: Diclofenac sodium Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 492 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze® Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald Scalp
Study Start Date : October 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diclofenac Sodium Gel, 3%
Diclofenac Sodium Gel, 3%, applied twice daily for 60 days
Drug: Diclofenac sodium
Active Comparator: Solaraze®
Solaraze® (diclofenac sodium) Gel, 3%, applied twice daily for 60 days
Drug: Diclofenac sodium
Other Name: Solaraze®

Placebo Comparator: Vehicle of Test Product
Vehicle of Test Product, Gel, applied twice daily for 60 days
Drug: Placebo



Primary Outcome Measures :
  1. Proportion of Patients with Treatment Success at Visit 4 [ Time Frame: Day 90 ]


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:   Yes
Criteria

Inclusion Criteria:

  • Willing and able to provide written informed consent for the study.
  • At least 18 years of age
  • Immunocompetent male or nonpregnant and nonlactating female. Each female subject of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day 1, must be willing to use an acceptable form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, contraceptive patches, contraceptive implant, vaginal contraceptive, double-barrier methods (e.g., condom and spermicide), contraceptive injection (Depo-Provera®), intrauterine device IUD (Mirena®), Essure®, and abstinence with a documented second acceptable method of birth control if the subject becomes sexually active.
  • Clinical diagnosis of AK, defined as ≥ 5 and ≤ 10 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions, each at least 4 mm in diameter, contained within a 25-cm2 treatment area on either the face or bald scalp, but not both face and scalp.
  • In general good health and free from any clinically significant disease, other than AK, that might interfere with the study evaluations.
  • Willing and able to understand and comply with the requirements of the study, apply the study medication as instructed, attend the required visits, comply with therapy prohibitions, and be able to complete the study.

Exclusion Criteria:

  • Presence of active gastrointestinal ulceration or bleeding.
  • Presence of severe renal or hepatic impairment.
  • Presence of atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, sunburn, or other possible confounding skin conditions on the treatment area of either the face or bald scalp.
  • Clinically significant systemic disease (immunological deficiencies), unstable medical disorder, life-threatening disease, or current malignancies.
  • Use within 6 months (180 days) prior to randomization of oral isotretinoin.
  • Use within 6 months (180 days) prior to randomization on the face or bald scalp where the designated treatment area is located of 1) chemical peel, 2) dermabrasion, 3) laser abrasion, 4) PUVA (psoralen plus ultraviolet A) therapy, or 5) UVB therapy.
  • Use within 6 months (180 days) prior to randomization of systemic cancer chemotherapy medications.
  • Use within 1 month (30 days) prior to randomization on the face of bald scalp where the designated treatment are is located 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, 10) other treatments for actinic keratosis.
  • Use within 1 month (30 days) prior to randomization of 1) immunomodulators or immunosuppressive therapies, 2) interferon, 3) systemic (oral and injectable) corticosteroids, 4) cytotoxic drugs. Intranasal or inhaled corticosteroids are acceptable if kept constant throughout the study. Intra-articular injection of steroids is acceptable for this study.
  • Known hypersensitivity or allergies to diclofenac, benzyl alcohol, polyethylene glycol monomethyl ether 359, hyaluronate sodium or any component of the study medication (in any dosage form).
  • Previous or current history of allergies to aspirin (ASA) or other NSAIDS.
  • Females who are pregnant, breastfeeding, intending to become pregnant during the study, or who do not agree to use an acceptable form of birth control during the study.
  • Any clinically significant condition or situation other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluation or optimal participation in the study.
  • Use of any investigational drug or investigational device within 1 month (30 days) prior to the randomization.
  • Previous participation in this study.
  • Current involvement in activities that require excessive or prolonged sun exposure.
  • Consumption of excessive alcohol, abuse of drugs, or a condition that could compromise the subject's ability to comply with study requirements.

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): NCT02611804


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Sponsors and Collaborators
Teva Pharmaceuticals USA

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Responsible Party: Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT02611804     History of Changes
Other Study ID Numbers: SYM 2015-01
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
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