A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis

NCT01962987 | Completed Phase 3 Results

• 1 other identifier: 71204901
• Study Type: interventional
• Target: 476
• Locations: 1 country
• Sites: 31

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

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With 100% Clearance of All AK Lesions Within the Treatment Area Assessed at Day 90

  The primary measure of bioequivalence will be evaluated using those patients who complete the study according to the (PP) population.

  90 days

Study Arms (3)

Diclofenac Sodium 3% gel - Test

EXPERIMENTAL

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.

Drug: Diclofenac sodium

Diclofenac Sodium 3% gel - Reference

ACTIVE COMPARATOR

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.

Drug: Diclofenac sodium

Placebo gel

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Diclofenac sodium DRUG

Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.

Also known as: Solaraze

Diclofenac Sodium 3% gel - Reference; Diclofenac Sodium 3% gel - Test

Placebo OTHER

Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.

Also known as: Vehicle base

Placebo gel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form, which meets all criteria of current FDA and HIPAA regulations.
• Immunocompetent male or non-pregnant, non-lactating female at least 18 years of age.
• 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.
• 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:
• 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.
• Had a normal menstrual cycle for the month prior to the start of treatment.
• Have a negative urine pregnancy test result upon entry into the study.
• 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.
• 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.
• Any skin type or race, providing the skin pigmentation will allow discernment of erythema.
• Willingness and capability to cooperate to the extent and degree required by the protocol.

You may not qualify if:

• Active gastrointestinal ulceration or bleeding.
• Current or history of severe renal or hepatic impairment.
• 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.
• Use within six months prior to randomization of oral isotretinoin.
• 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
• 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.
• Known allergies to diclofenac sodium, benzyl alcohol, polyethylene glycol monomethyl ether 359, hyaluronate sodium or any excipients in the test or reference gels.
• Receiving 5-Fluorouracil or other systemic cancer chemotherapy within 6 months prior to randomization.
• Any condition, medical, psychological, or social, that, in the Investigator's opinion, would interfere with participation in the study.
• Women who are pregnant, planning pregnancy or lactating.
• Participation in any investigational drug study within 30 days of randomization or previous participation in this study.
• Employees of the research center or Investigator.
• Family members of employees of the research center or Investigator.

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (31)

Investigator Site 23

Fremont, California, United States

Location

Investigator Site 9

Long Beach, California, United States

Location

Investigator Site 12

Newport Beach, California, United States

Location

Investigator Site 2

San Diego, California, United States

Location

Investigator Site 24

San Ramon, California, United States

Location

Investigator Site 14

Denver, Colorado, United States

Location

Investigator Site 17

Denver, Colorado, United States

Location

Investigator Site 21

Brandon, Florida, United States

Location

Investigator Site 25

Dunedin, Florida, United States

Location

Investigator Site 20

Fort Myers, Florida, United States

Location

Investigator Site 15

Jacksonville, Florida, United States

Location

Investigator Site 16

Miami, Florida, United States

Location

Investigator Site 6

Ormond Beach, Florida, United States

Location

Investigator Site 19

Winter Park, Florida, United States

Location

Investigator Site 22

Atlanta, Georgia, United States

Location

Investigator Site 11

Boise, Idaho, United States

Location

Investigator Site 8

Arlington Heights, Illinois, United States

Location

Investigator Site 28

Plainfield, Indiana, United States

Location

Investigator Site 31

Louisville, Kentucky, United States

Location

Investigator Site 27

Fridley, Minnesota, United States

Location

Investigator Site 13

Bozeman, Montana, United States

Location

Investigator Site 26

New Bern, North Carolina, United States

Location

Investigator Site 3

Raleigh, North Carolina, United States

Location

Investigator Site 18

Wilmington, North Carolina, United States

Location

Investigator Site 30

Cincinnati, Ohio, United States

Location

Investigator Site 1

Hazleton, Pennsylvania, United States

Location

Investigator Site 5

Clinton, South Carolina, United States

Location

Investigator Site 4

Johnson City, Tennessee, United States

Location

Investigator Site 10

Nashville, Tennessee, United States

Location

Investigator Site 7

West Jordan, Utah, United States

Location

Investigator Site 29

Midlothian, Virginia, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Senior Director, CE Studies
• Organization: Teva Pharmaceuticals USA, Inc.

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Henry Lau, PhD

  Actavis Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 16, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: July 20, 2020
• Results First Posted: July 20, 2020

Record last verified: 2020-07

Locations

US (31)