Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses



Status:Completed
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:1/12/2019
Start Date:October 27, 2016
End Date:September 6, 2017

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses

This research study is being done to compare the safety and effectiveness of GDC 695 (test
drug) against the currently marketed reference drug (diclofenac sodium gel, 3%) and to
establish that these two drugs work better than placebo in the treatment of actinic
keratosis.


Inclusion Criteria:

- Has provided written informed consent.

- Immunocompetent male and/or non-pregnant female, 18 years of age or older.

- Willing and able to apply the test article(s) as directed, comply with study
instructions, and commit to all follow-up visits for the duration of the study.

- Clinical diagnosis of actinic keratosis.

- In good general health and free of any disease state or physical condition.

- Women, must be post-menopausal, surgically sterile, or use an effective method of
birth control with a negative urine pregnancy test (UPT) at the Baseline Visit (Day
1).

Exclusion Criteria:

- Women who are pregnant, breastfeeding, or are planning to become pregnant or
breastfeed during the study.

- Is currently enrolled in another investigational drug or device study or has used an
investigational drug or investigational device within 30 days prior to the Baseline
Visit (Day 1).

- Has the need or plans to be exposed to artificial tanning devices or excessive
sunlight during the study.

- Is immunosuppressed (e.g., human immunodeficiency virus [ HIV], systemic malignancy,
graft host disease, etc.) or is taking medications that suppress the immune system.

- Has experienced an unsuccessful outcome from previous topical diclofenac sodium
therapy.

- Has a history of sensitivity to any of the ingredients in the test articles or other
excipients in the test or reference drug.

- Has signs or symptoms consistent with the aspirin (ASA) triad.

- Has used topical medications: corticosteroids, alpha hydroxy acids (e.g., glycolic
acid, lactic acid, etc. >5%), beta hydroxy acid (salicylic acid >2%), urea >2%,
5-fluorouracil, diclofenac, imiquimod, ingenol mebutate, aminolevulinic acid (ALA) or
prescription retinoids (e.g., tazarotene, adapalene, tretinoin), over-the-counter
(OTC) products labeled as scrubs of any kind which are used to smooth the skin (as
they contain some form of exfoliant such as nut shells, coffee grounds, polymer
particles, etc.) within the selected treatment area (face or bald scalp) within one
month prior to the Baseline Visit.

- Has had cryodestruction or chemodestruction, curettage, photodynamic therapy (PDT),
surgical excision, or other treatments for AK within the selected treatment area (face
or bald scalp) within one month prior to the Baseline Visit.

- Has used oral corticosteroid therapy, interferon, cytotoxic drugs, immunomodulators,
immunosuppressive therapies, or retinoids within one month prior to the Baseline
Visit.

- Has used oral isotretinoin within six months prior to the Baseline Visit.

- Has used chemical peels, including but not limited to alphahydroxy acid, betahydroxy
acid, bichloroacetic acid, trichloroacetic acid, and phenol within the selected
treatment area (face or bald scalp) within six months prior to the Baseline Visit.

- Has had dermatologic procedures or surgeries such as: laser resurfacing, PUVA
(Psoralen + ultraviolet A) therapy, ultraviolet B (UVB) therapy, ALA-PDT, or
dermabrasion within the selected treatment area (face or bald scalp) within six months
prior to the Baseline Visit.

- Has lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or
untreated skin cancers within the selected treatment area (face or bald scalp).

- Has active gastrointestinal ulceration or bleeding or has a history of
gastrointestinal bleeds due to use of aspirin or other NSAIDs.

- Has severe renal or hepatic impairment.

- Has any condition which, in the investigator's opinion, could interfere with the
evaluation of the test drugs or that could make it unsafe or preclude the subject's
ability to fully participate in this research study.
We found this trial at
16
sites
165
mi
from 43215
Carmel, IN
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Albuquerque, New Mexico
Phone: 505-247-4220
1333
mi
from 43215
Albuquerque, NM
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Anderson, South Carolina
Phone: 864-716-0063
378
mi
from 43215
Anderson, SC
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Clearwater, Florida 33756
Phone: 813-849-5566
830
mi
from 43215
Clearwater, FL
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Fort Smith, Arkansas 72901
Phone: 479-649-3376
698
mi
from 43215
Fort Smith, AR
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Greenville, South Carolina 29605
Phone: 864-351-9632
358
mi
from 43215
Greenville, SC
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Norfolk, Virginia 23507
Phone: 757-627-7446
422
mi
from 43215
Norfolk, VA
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North Miami Beach, Florida 33162
Phone: 305-652-8600
983
mi
from 43215
North Miami Beach, FL
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747
mi
from 43215
Ocala, FL
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Plainfield, Indiana 46168
Phone: 317-837-6082
179
mi
from 43215
Plainfield, IN
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Saint Joseph, Missouri 64507
Phone: 816-364-1515
626
mi
from 43215
Saint Joseph, MO
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San Diego, California
Phone: 858-292-8641
1951
mi
from 43215
San Diego, CA
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San Ramon, California 94583
Phone: 925-413-1451
2083
mi
from 43215
San Ramon, CA
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1778
mi
from 43215
Spokane, WA
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Tampa, Florida
Phone: 813-948-7550
831
mi
from 43215
Tampa, FL
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Warwick, Rhode Island 02886
Phone: 401-739-9350
615
mi
from 43215
Warwick, RI
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