Actinic KeratosisPhase 3NCT02952898

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

A Phase 3 study testing GDC 695 and Diclofenac Sodium Gel, 3% in people with Actinic Keratosis, run by Balmoral Medical company at 16 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

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Actinic Keratosis
What is being tested?: GDC 695 and Diclofenac Sodium Gel, 3%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 665 participants
Where: 16 sitesUnited States
Study dates: 27 Oct 2016to 6 Sep 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Show all 17Show fewer

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.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Site 21
Albuquerque, New Mexico, 87106
Site 26
Anderson, South Carolina, 29621
Site 05
Carmel, Indiana, 46032
Site 22
Clearwater, Florida, 33756
Site 07
Fort Smith, Arkansas, 72916
Site 04
Greenville, South Carolina, 29607
Site 28
Norfolk, Virginia, 23507
Site 01
North Miami Beach, Florida, 33162
Site 27
Ocala, Florida, 34471
Site 02
Plainfield, Indiana, 46168
Site 25
Saint Joseph, Missouri, 64506
Site 14
San Diego, California, 92117
Site 24
San Ramon, California, 94582
Site 10
Spokane, Washington, 99202
Site 12
Tampa, Florida, 33609
Site 03
Warwick, Rhode Island, 02886

Other trials in United States

About this study

Official title: 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

Conditions: Actinic Keratosis
Being tested: GDC 695, Diclofenac Sodium Gel, 3%, Vehicle gel
Keywords: solar keratoses
Medical subject headings: Keratosis, Actinic

What participants receive

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

GDC 695Drug
GDC 695 is a topical gel.
Diclofenac Sodium Gel, 3%Drug
Diclofenac sodium gel, 3% is an FDA-approved drug.
Vehicle gelDrug
Vehicle topical gel contains 0.0% of active drug and is color matched to the other two active test drugs.

Study groups in NCT02952898
Study group	Role	What they receive
Test Drug	Experimental	GDC 695 gel applied topically as directed. Receives: Drug: GDC 695
Reference Drug	Active comparator	Diclofenac sodium gel, 3% applied topically as directed. Receives: Drug: Diclofenac Sodium Gel, 3%
Placebo	Placebo comparator	Vehicle gel applied topically as directed. Receives: Drug: Vehicle gel

What is being measured

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

Number of Subjects With Complete Clearance of AK Lesions
Complete Clearance was defined as 100% clearance of all Actinic Keratosis (AK) lesions (having a count of zero AKs) in the treatment area (face or bald scalp) at the Day 90 visit (30 Days Post Treatment).
Measured: Day 90 (30 days after completion of 60 days of treatment)

Timeline

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

27 Oct 20166 Sep 2017

First posted2 Nov 2016 (estimated)
Study start27 Oct 2016
Primary completion11 Jul 2017
Study completion6 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Actinic KeratosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 665 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02952898
Sponsor's protocol ID: GDC-695-001
Status last verified: Jan 2020
First submitted: 31 Oct 2016
Last updated: 7 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma

All Actinic Keratosis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02952898
Acronym / sponsor ID: GDC-695-001
Conditions: Actinic Keratosis
Keywords: solar keratoses
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 665 participants (actual)
Lead sponsor: Balmoral Medical companyIndustry (pharma, biotech, devices)
Study start: 27 Oct 2016 (actual)
Primary completion: 11 Jul 2017 (actual)
Study completion: 6 Sep 2017 (actual)
First posted: 2 Nov 2016 (estimated)
Results: Posted 10 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Test Drug	Experimental	Drug: GDC 695GDC 695 gel applied topically as directed.
Reference Drug	Active comparator	Drug: Diclofenac Sodium Gel, 3%Diclofenac sodium gel, 3% applied topically as directed.
Placebo	Placebo comparator	Drug: Vehicle gelVehicle gel applied topically as directed.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (17 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GDC 695GDC 695 is a topical gel.	Drug	Test Drug
Diclofenac Sodium Gel, 3%Diclofenac sodium gel, 3% is an FDA-approved drug.	Drug	Reference Drug
Vehicle gelVehicle topical gel contains 0.0% of active drug and is color matched to the other two active test drugs.	Drug	Placebo

Primary outcome

Number of Subjects With Complete Clearance of AK Lesions
Time frame: Day 90 (30 days after completion of 60 days of treatment)
Complete Clearance was defined as 100% clearance of all Actinic Keratosis (AK) lesions (having a count of zero AKs) in the treatment area (face or bald scalp) at the Day 90 visit (30 Days Post Treatment).

Results and safety

Results posted to the registry on 10 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GDC 695 Gel	220	198
Diclofenac Sodium Gel	221	202
Placebo	224	209

Primary outcome: Number of Subjects With Complete Clearance of AK Lesions

Time frame: Day 90 (30 days after completion of 60 days of treatment). Number. Unit: percentage of participants

Measure	GDC 695 Gel n = 215	Diclofenac Sodium Gel n = 218	Placebo n = 221
Value	30.2	25.7	9.5

GDC 695 Gel vs Placebo: p <0.0001, Chi-squared, Corrected
Diclofenac Sodium Gel vs Placebo: p <0.0001, Chi-squared, Corrected

Population analysed: Analysis shown is based on the modified Intent-to-Treat (mITT) population, defined as all randomized subjects who met the following requirements, 1) met all inclusion/exclusion criteria; 2) applied at least one dose of test article; 3) and returned for at least one post-baseline evaluation clinic visit (Visits 3, 5, or 6).

Adverse events

Time frame: Treatment Emergent Adverse Events (TEAEs) were collected from study Day 1 (enrollment/first dose) to study completion (Day 90) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GDC 695	1 of 218 (0.5%)	19 of 218 (8.7%)	0 of 218
Diclofenac Sodium Gel	3 of 220 (1.4%)	14 of 220 (6.4%)	0 of 220
Placebo	5 of 223 (2.2%)	6 of 223 (2.7%)	0 of 223

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Actinic Keratosis

Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GDC 695 and Diclofenac Sodium Gel, 3% in people with Actinic Keratosis, run by Balmoral Medical company at 16 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 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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?

Yes. Results are posted in the registry (first posted 10 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Subjects With Complete Clearance of AK Lesions (time frame: Day 90 (30 days after completion of 60 days of treatment)). 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 NCT02952898.

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 7 Jan 2020.