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A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design Study Comparing Diclofenac Sodium Gel 3% (Taro Pharmaceuticals Inc.) to Solaraze® (Diclofenac Sodium) Gel 3% (Fougera Pharms) in the Treatment of Actinic Keratosis.


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Actinic Keratosis

Thank you

Trial Information

A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design Study Comparing Diclofenac Sodium Gel 3% (Taro Pharmaceuticals Inc.) to Solaraze® (Diclofenac Sodium) Gel 3% (Fougera Pharms) in the Treatment of Actinic Keratosis.


Inclusion Criteria:



- Signed informed consent form.

- Immunocompetent male or non-pregnant, non-lactating female at least 18 years of age.

- Diagnosis of AK with at least 5 and no more than 10 clinically typical, visable,
discrete, nonhyperkeratotic, nonhypertrophic AK lesions each at least 4 mm in
diameter on the face and/or bald scalp contained within a 25 cm2 treatment area.

- Women either must be 1 year post-menopausal, 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 treatment start, or used barrier methods
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 and agree to use a medically accepted form of
birth control 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 risks 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.

Exclusion Criteria:

- 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 confounding skin conditions on the face
or bald scalp.

- Use within six months prior to randomization of oral isotretinoin.

- Use within six months prior to baseline on the face or bald scalp of chemical peel,
dermabrasion, laser abrasion, PUVA therapy or UVB therapy.

- Use within one month prior to baseline on the face or bald scalp of cryodestruction
or chemodestruction, curettage, photodynamic therapy, surgical excision, topical
5-fluorouracil, topical corticosteroids, topical diclofenac, topical Imiquimod,
topical retinoids or other treatments for actinic keratosis including glycolic acids
or over-the-counter products containing retinol, alpha or beta hydroxy acids.

- Use within one month prior to baseline of immunomodulators or immunosuppressive
therapies, interferon, systemic corticosteroids or cytotoxic drugs.

- 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 study entry.

- Any condition, medical, psychological or social, that, in the investigator's opinion,
would interfere with participation in the study.

- Women who are pregnant or planning pregnancy or lactating during the study.

- Participation in any investigational drug study within 30 days of enrollment or
previous participation in this study.

- Employees or family members of employees of the research center or investigator.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Bioequivalence

Outcome Description:

Bioequivalence will be determined by evaluating the proportion of patients in the test and reference groups with 100% clearance of all AK lesions in the treatment area.

Outcome Time Frame:

Study day 90 (30 days after completion of 60 days of treatment)

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

DCSG 1213

NCT ID:

NCT01742663

Start Date:

October 2012

Completion Date:

December 2013

Related Keywords:

  • Actinic Keratosis
  • Diclofenac Sodium Gel 3%
  • Solaraze® (diclofenac sodium) Gel 3%
  • Actinic Keratosis
  • Keratosis
  • Keratosis, Actinic

Name

Location

Academic Dermatology AssociatesAlbuquerque, New Mexico  87106
Tennessee Clinical Research CenterNashville, Tennessee  37221
Altman Dermatology AssociatesArlington Heights, Illinois  60004
Medical Center for Clinical ResearchSan Diego, California  92108
Northern California ResearchSacramento, California  95821
Dermatology Associates of Knoxville, PCKnoxville, Tennessee  37922
Northwest Clinical TrialsBoise, Idaho  83704
Horizons Clinical Research Center, LLCDenver, Colorado  
FXM Research Corp.Miami, Florida  
Dermatology Consulting ServicesHigh Point, North Carolina  
The Indiana Clinical Trials Center, PCPlainfield, Indiana  46168
FXM Research MiramarMiramar, Florida  33027
Elite Clinical Studies, LLCPhoenix, Arizona  85018
Silverberg Surgical and Medical GroupNewport Beach, California  92660
Center for Dermatology Clinical Research, Inc.Fremont, California  94538
SC Clinical Research, Inc.Garden Grove, California  92844
Alliance ResearchLong Beach, California  90813
Florida Center for Dermatology, P.A.Jacksonville, Florida  32204
Ormond Medical Arts Pharmaceutical Research CenterOrmond Beach, Florida  32174
Spencer Clinical ServicesSt. Petersburg, Florida  33716
Karl G. Heine, MD DermatologyHenderson, Nevada  89052
Stephen Miller, MD, PASan Antonio, Texas  78249