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Actinic KeratosisPhase 3NCT02611804

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

A Phase 3 study testing Diclofenac sodium in people with Actinic Keratosis, run by Teva Pharmaceuticals USA at 30 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Actinic Keratosis
What is being tested?
Diclofenac sodium
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
492 participants
Where
30 sitesUnited States
Study dates
Oct 2015to Aug 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United States30 sites

  • Radiant Research

    Anderson, South Carolina, 29621

  • DermResearch, Inc.

    Austin, Texas, 78759

  • Radiant Research

    Cincinnati, Ohio, 45249

  • Olympian Clinical Research

    Clearwater, Florida, 33757

  • Tampa Bay Medical Research

    Clearwater, Florida, 33761

  • Horizons Clinical Research Center

    Denver, Colorado, 80220

  • Center for Dermatology Clinical Research, Inc.

    Fremont, California, 94538

  • Greenville Dermatology

    Greenville, South Carolina, 29607

  • Dermatology Consulting Services

    High Point, North Carolina, 27262

  • The Center for Skin Research

    Houston, Texas, 77056

  • Dermatology Associates of Knoxville

    Knoxville, Tennessee, 37917

  • The Skin Wellness Center

    Knoxville, Tennessee, 37922

  • DS Research

    Louisville, Kentucky, 40202

  • The Education and Research Foundation

    Lynchburg, Virginia, 24501

  • Agave Clinical Research

    Mesa, Arizona, 85202

  • Tennessee Clinical Research Center

    Nashville, Tennessee, 37215

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • ACRC Trials

    Plano, Texas, 75024

  • Dermatology Research Center

    Salt Lake City, Utah, 84117

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas, 78229

  • Stephen Miller, M.D.

    San Antonio, Texas, 78249

  • Medical Center for Clinical Research

    San Diego, California, 92108

  • TCR Medical Corporation

    San Diego, California, 92123

  • Clinical Science Institute

    Santa Monica, California, 90404

  • Premier Clinical Research

    Spokane, Washington, 99202

  • Radiant Research, Inc.

    Tucson, Arizona, 85712

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • DermOne of North Carolina

    Wilmington, North Carolina, 28401

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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.

Being tested
Diclofenac sodium, Placebo
Medical subject headings
Keratosis, Actinic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diclofenac sodiumDrug

  • Diclofenac sodiumDrug

    Also called Solaraze®

  • PlaceboDrug

Study groups in NCT02611804
Study groupRoleWhat they receive
Diclofenac Sodium Gel, 3%ExperimentalDiclofenac Sodium Gel, 3%, applied twice daily for 60 days
Receives: Drug: Diclofenac sodium
Solaraze®Active comparatorSolaraze® (diclofenac sodium) Gel, 3%, applied twice daily for 60 days
Receives: Drug: Diclofenac sodium
Vehicle of Test ProductPlacebo comparatorVehicle of Test Product, Gel, applied twice daily for 60 days
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Patients with Treatment Success at Visit 4

    Measured: Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
492 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02611804
Sponsor's protocol ID
SYM 2015-01
Status last verified
May 2017
First submitted
19 Nov 2015
Last updated
5 May 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Diclofenac sodium in people with Actinic Keratosis, run by Teva Pharmaceuticals USA at 30 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients with Treatment Success at Visit 4 (time frame: Day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02611804.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.

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