Actinic KeratosesPhase 3NCT03826550
Therapeutic Equivalence of Diclofenac Sodium Gel 3% vs Solaraze ® in the Treatment of Actinic Keratosis
A Phase 3 study testing Diclofenac Sodium Gel and Solaraze 3% Topical Gel in people with Actinic Keratoses, run by Encube Ethicals Pvt. Ltd. at 24 sites in United States.
Trial summary
Therapeutic Equivalence of Diclofenac Sodium Gel 3% and Solaraze ®, 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 Keratoses
- What is being tested?
- Diclofenac Sodium Gel and Solaraze 3% Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 655 participants
- Where
- 24 sitesUnited States
- Study dates
- 12 Jan 2018to 3 Jul 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Institutional Review Board (IRB)-approved informed consent form that meets all criteria of current Food and Drug Administration regulations.
- Male or non-pregnant, non-lactating female, 18 years of age or older.
- Diagnosis of AK with at least five and no more than ten clinically typical, visible, discrete, non-hyperkeratotic, non-hypertrophic AK lesions, each at least 4 mm in diameter, contained within a contiguous 25 cm2 treatment area on the face and/or bald scalp.
- Females of childbearing potential must not be pregnant or lactating at Visit 1 (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 mIU/ mL or equivalent units of human chorionic gonadotropin). Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, intrauterine device, a double-barrier method, oral, transdermal, injected, or implanted non-hormonal or hormonal contraceptive) throughout the study. Female patients using hormonal contraceptives should have been on the same product/dosing regimen for at least 28 days before Visit 1 and should not change this regimen during the study. A sterile sexual partner is not considered an adequate form of birth control.
- Skin pigmentation that will allow discernment of erythema.
Who cannot join
- Females who are pregnant, lactating or planning to become pregnant during the study period.
- Active gastrointestinal ulceration or bleeding.
- Current evidence or history of severe renal or hepatic impairment.
- Known allergy or hypersensitivity to diclofenac, benzyl alcohol, polyethylene glycol monomethyl ether 359, hyaluronate sodium or other excipients in the test, reference or vehicle gel.
- Known allergy or hypersensitivity to other NSAIDs, including aspirin.
- Presence of atopic dermatitis, basal cell carcinoma, squamous cell carcinoma, eczema, psoriasis, rosacea, sunburn, exfoliative dermatitis, open or recent skin wounds, active infections or other possible skin conditions on the face or bald scalp that in the Investigator's opinion would interfere with the study assessments or put the patient at risk.
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- Use of oral isotretinoin within six months before randomization.
- Use within six months before Visit 1 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 before Visit 1 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 AK including glycolic acids or over the- counter (OTC) products containing retinol, alpha or beta hydroxy acids. The occasional use of ophthalmic, intranasal or inhaled corticosteroids (e.g., management of allergic conjunctivitis) is acceptable and not reason for exclusion. Use of inhaled corticosteroids for the management of chronic and stable conditions (e.g., persistent asthma and chronic obstructive pulmonary disease [COPD]) is acceptable as long as it has been on a stable dose for a minimum of three months before the start of the study and up to 1 mg/day.
- Use within one month before Visit 1 of 1) immunomodulators or immunosuppressive therapies, 2) interferon, 3) systemic corticosteroids or 4) cytotoxic drugs.
- Receipt of 5-Fluorouracil or other systemic cancer chemotherapy within 6 months before Visit 1.
- Any condition, medical, psychological, or social, that, in the Investigator's opinion, would interfere with participation in the study or put the patient at risk.
- Inability to understand the requirements of the study and the relative information or are unable or not willing to comply with the study protocol.
- Receipt of any drug as part of a research study within 30 days before Visit 1.
- Employees of the Investigator or research center or their immediate family members.
- Patients who have participated in this study previously.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Anderson Dermatology
Anderson, South Carolina, 29621
Sirius Clinical Research, LLC
Austin, Texas, 78759
Northwest Clinical Trials
Boise, Idaho, 82704
Dermatology Trial Associates
Bryant, Arkansas, 71011
Sterling Research Group
Cincinnati, Ohio, 45246
Universal Medical and Research Center, LLC
Coral Gables, Florida, 33134
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Greenville Dermatology, LLC
Greenville, South Carolina, 29607
DermDox Centers for Dermatology
Hazleton, Pennsylvania, 18201
DTRL, Inc.
Henderson, Nevada, 89052
Dermatology Consulting Services
High Point, North Carolina, 27262
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, 32256
Health Awareness, Inc.
Jupiter, Florida, 33458
Multi-Speciality Research Associates, Inc.
Lake City, Florida, 32055
DS Research
Louisville, Kentucky, 40241
FXM Research
Miami, Florida, 33175
FXM Research Miramar
Miramar, Florida, 33027
DS Research
New Albany, Indiana, 47150
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, 32174
West Coast Research
San Ramon, California, 94582
Moore Clinical Research
Tampa, Florida, 33618
Forward Clinical Trials
Tampa, Florida, 33624
PEAK Research, LLC
Upper Saint Clair, Pennsylvania, 15241
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel 3% (Encube Ethicals) Compared to Solaraze® (Diclofenac Sodium) Gel 3% (Fougera Pharmaceuticals Inc.) in the Treatment of Actinic Keratosis
Therapeutic Equivalence of Diclofenac Sodium Gel 3% and Solaraze ®, in the treatment of Actinic Keratosis
Read the detailed description
A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel 3% (Encube Ethicals) Compared to Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharmaceuticals Inc.) in the Treatment of Actinic Keratosis
- Conditions
- Actinic Keratoses
- Being tested
- Diclofenac Sodium Gel, Solaraze 3% Topical Gel, 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 Sodium GelDrug
Twice daily for 60 days. Each patient is expected to receive 120 doses
Solaraze 3% Topical GelDrug
Twice daily for 60 days. Each patient is expected to receive 120 doses
PlaceboOther
Twice daily for 60 days. Each patient is expected to receive 120 doses
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac Sodium Gel3% | Experimental | Diclofenac Sodium Gel 3%, dosed twice daily for 60 days. Receives: Drug: Diclofenac Sodium Gel |
| Solaraze | Active comparator | Solaraze Gel dosed twice daily for 60 days. Receives: Drug: Solaraze 3% Topical Gel |
| Placebo | Placebo comparator | Placebo Gel dosed twice daily for 60 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients in each treatment group with 100% clearance of all AK Lesions
Measured: Day 90 (30 days after completion of a 60 day treatment)
Superiority of the test and reference products against the placebo
Measured: Day 90 (30 days after completion of a 60 day treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start12 Jan 2018
- Primary completion30 Jun 2018
- Study completion3 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosesStudies 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
- Model description
- Randomized, double-blind, placebo-controlled, three-arm, parallel group, multiple-site bioequivalence study with clinical endpoints.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 655 participants (actual)
Sponsor and investigators
- Lead sponsor
- Encube Ethicals Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826550
- Sponsor's protocol ID
- ENC16102
- Status last verified
- Jan 2019
- First submitted
- 30 Jan 2019
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel 3% (Encube Ethicals) Compared to Solaraze® (Diclofenac Sodium) Gel 3% (Fougera Pharmaceuticals Inc.) in the Treatment of Actinic Keratosis
- ClinicalTrials.gov ID
- NCT03826550
- Acronym / sponsor ID
- ENC16102
- Conditions
- Actinic Keratoses
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 655 participants (actual)
- Lead sponsor
- Encube Ethicals Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 3 Jul 2018 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Therapeutic Equivalence of Diclofenac Sodium Gel 3% and Solaraze ®, in the treatment of Actinic Keratosis
Detailed description
A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel 3% (Encube Ethicals) Compared to Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharmaceuticals Inc.) in the Treatment of Actinic Keratosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, double-blind, placebo-controlled, three-arm, parallel group, multiple-site bioequivalence study with clinical endpoints.
| Arm | Type | Receives |
|---|---|---|
| Diclofenac Sodium Gel3% | Experimental | Drug: Diclofenac Sodium GelDiclofenac Sodium Gel 3%, dosed twice daily for 60 days. |
| Solaraze | Active comparator | Drug: Solaraze 3% Topical GelSolaraze Gel dosed twice daily for 60 days. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo Gel dosed twice daily for 60 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed Institutional Review Board (IRB)-approved informed consent form that meets all criteria of current Food and Drug Administration regulations.
- Male or non-pregnant, non-lactating female, 18 years of age or older.
- Diagnosis of AK with at least five and no more than ten clinically typical, visible, discrete, non-hyperkeratotic, non-hypertrophic AK lesions, each at least 4 mm in diameter, contained within a contiguous 25 cm2 treatment area on the face and/or bald scalp.
- Females of childbearing potential must not be pregnant or lactating at Visit 1 (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 mIU/ mL or equivalent units of human chorionic gonadotropin). Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, intrauterine device, a double-barrier method, oral, transdermal, injected, or implanted non-hormonal or hormonal contraceptive) throughout the study. Female patients using hormonal contraceptives should have been on the same product/dosing regimen for at least 28 days before Visit 1 and should not change this regimen during the study. A sterile sexual partner is not considered an adequate form of birth control.
- Skin pigmentation that will allow discernment of erythema.
Key exclusion criteria (16 listed)
- Females who are pregnant, lactating or planning to become pregnant during the study period.
- Active gastrointestinal ulceration or bleeding.
- Current evidence or history of severe renal or hepatic impairment.
- Known allergy or hypersensitivity to diclofenac, benzyl alcohol, polyethylene glycol monomethyl ether 359, hyaluronate sodium or other excipients in the test, reference or vehicle gel.
- Known allergy or hypersensitivity to other NSAIDs, including aspirin.
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 |
|---|---|---|
| Diclofenac Sodium GelTwice daily for 60 days. Each patient is expected to receive 120 doses | Drug | Diclofenac Sodium Gel3% |
| Solaraze 3% Topical GelTwice daily for 60 days. Each patient is expected to receive 120 doses | Drug | Solaraze |
| PlaceboTwice daily for 60 days. Each patient is expected to receive 120 doses | Other | Placebo |
Primary outcome
proportion of patients in each treatment group with 100% clearance of all AK Lesions
Time frame: Day 90 (30 days after completion of a 60 day treatment)
Superiority of the test and reference products against the placebo
Time frame: Day 90 (30 days after completion of a 60 day treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Individual participant dataSharing planned: No
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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.
24 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 Diclofenac Sodium Gel and Solaraze 3% Topical Gel in people with Actinic Keratoses, run by Encube Ethicals Pvt. Ltd. at 24 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 5 inclusion and 16 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 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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 in each treatment group with 100% clearance of all AK Lesions (time frame: Day 90 (30 days after completion of a 60 day treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2019.