Actinic KeratosisPhase 3NCT01962987
A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis
A Phase 3 study testing Diclofenac sodium in people with Actinic Keratosis, run by Actavis Inc. at 31 sites in United States.
Trial summary
To compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3% (Actavis) to the marketed formulation Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms) in the treatment of the actinic keratosis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- 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
- 476 participants
- Where
- 31 sitesUnited States
- Study dates
- Mar 2013to Sep 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form, which meets all criteria of current FDA and HIPAA regulations.
- Immunocompetent male or non-pregnant, non-lactating female at least 18 years of age.
- Diagnosis of AK with ≥ 5 and < 10 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions each at least 4 mm in diameter on the face and/or bald scalp contained within a 25cm2 treatment area.
- Women either must be 1 year post-menopausal (no menstrual periods for at least 12 months), 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 the start of treatment period of the study, or used barrier methods such as diaphragm plus spermicide or condom plus spermicide consistently, at least 14 days before study gel administration.
- Had a normal menstrual cycle for the month prior to the start of treatment.
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- Have a negative urine pregnancy test result upon entry into the study.
- Agree to use a medically accepted form of birth control (oral, implant, injectable or transdermal contraceptives, intrauterine device, condom plus spermicide, diaphragm plus spermicide) or practice abstinence 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 risk 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.
Who cannot join
- 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 skin conditions on the face or bald scalp that in the investigator's opinion would interfere with the study assessments.
- Use within six months prior to randomization of oral isotretinoin.
- Use within six months prior to randomization 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 prior to randomization 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 actinic keratosis including glycolic acids or over-the-counter products containing retinol, alpha or beta hydroxy acids.
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- Use within one month prior to randomization of 1)immunomodulators or immunosuppressive therapies, 2)interferon, 3) systemic corticosteroids or 4) cytotoxic drugs. (The occasional use of ophthalmic, nasal or inhaled steroids is acceptable and not reason for exclusion)
- 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 randomization.
- Any condition, medical, psychological, or social, that, in the Investigator's opinion, would interfere with participation in the study.
- Women who are pregnant, planning pregnancy or lactating.
- Participation in any investigational drug study within 30 days of randomization or previous participation in this study.
- Employees of the research center or Investigator.
- Family members of employees of the research center or Investigator.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Investigator Site 8
Arlington Heights, Illinois
Investigator Site 22
Atlanta, Georgia
Investigator Site 11
Boise, Idaho
Investigator Site 13
Bozeman, Montana
Investigator Site 21
Brandon, Florida
Investigator Site 30
Cincinnati, Ohio
Investigator Site 5
Clinton, South Carolina
Investigator Site 14
Denver, Colorado
Investigator Site 17
Denver, Colorado
Investigator Site 25
Dunedin, Florida
Investigator Site 20
Fort Myers, Florida
Investigator Site 23
Fremont, California
Investigator Site 27
Fridley, Minnesota
Investigator Site 1
Hazleton, Pennsylvania
Investigator Site 15
Jacksonville, Florida
Investigator Site 4
Johnson City, Tennessee
Investigator Site 9
Long Beach, California
Investigator Site 31
Louisville, Kentucky
Investigator Site 16
Miami, Florida
Investigator Site 29
Midlothian, Virginia
Investigator Site 10
Nashville, Tennessee
Investigator Site 26
New Bern, North Carolina
Investigator Site 12
Newport Beach, California
Investigator Site 6
Ormond Beach, Florida
Investigator Site 28
Plainfield, Indiana
Investigator Site 3
Raleigh, North Carolina
Investigator Site 2
San Diego, California
Investigator Site 24
San Ramon, California
Investigator Site 7
West Jordan, Utah
Investigator Site 18
Wilmington, North Carolina
Investigator Site 19
Winter Park, Florida
About this study
Official title: A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design Study Comparing Diclofenac Sodium Gel 3% (Actavis) to Solaraze ® (Diclofenac Sodium) Gel 3% (Fougera Pharms) in the Treatment of Actinic Keratosis
To compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3% (Actavis) to the marketed formulation Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms) in the treatment of the actinic keratosis
- Conditions
- Actinic Keratosis
- 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
Also called Solaraze
Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
PlaceboOther
Also called Vehicle base
Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac Sodium 3% gel - Test | Experimental | The diclofenac sodium 3% test gel is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Test Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site. Receives: Drug: Diclofenac sodium |
| Diclofenac Sodium 3% gel - Reference | Active comparator | The Reference diclofenac sodium 3% gel (Solaraze®) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Reference (Solaraze®) Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site. Receives: Drug: Diclofenac sodium |
| Placebo gel | Placebo comparator | The placebo gel (contains no active ingredient) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough placebo gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With 100% Clearance of All AK Lesions Within the Treatment Area Assessed at Day 90
The primary measure of bioequivalence will be evaluated using those patients who complete the study according to the (PP) population.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2013
- Study completionSep 2013
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 476 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henry Lau, PhD, Study director, Actavis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962987
- Sponsor's protocol ID
- 71204901
- Status last verified
- Jul 2020
- First submitted
- 10 Oct 2013
- Last updated
- 20 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design Study Comparing Diclofenac Sodium Gel 3% (Actavis) to Solaraze ® (Diclofenac Sodium) Gel 3% (Fougera Pharms) in the Treatment of Actinic Keratosis
- ClinicalTrials.gov ID
- NCT01962987
- Acronym / sponsor ID
- 71204901
- Conditions
- Actinic Keratosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 476 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 Oct 2013 (estimated)
- Results
- Posted 20 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3% (Actavis) to the marketed formulation Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms) in the treatment of the actinic keratosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diclofenac Sodium 3% gel - Test | Experimental | Drug: Diclofenac sodiumThe diclofenac sodium 3% test gel is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Test Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site. |
| Diclofenac Sodium 3% gel - Reference | Active comparator | Drug: Diclofenac sodiumThe Reference diclofenac sodium 3% gel (Solaraze®) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Reference (Solaraze®) Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site. |
| Placebo gel | Placebo comparator | Other: PlaceboThe placebo gel (contains no active ingredient) is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough placebo gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed informed consent form, which meets all criteria of current FDA and HIPAA regulations.
- Immunocompetent male or non-pregnant, non-lactating female at least 18 years of age.
- Diagnosis of AK with ≥ 5 and < 10 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions each at least 4 mm in diameter on the face and/or bald scalp contained within a 25cm2 treatment area.
- Women either must be 1 year post-menopausal (no menstrual periods for at least 12 months), surgically sterile, or if they are of child-bearing potential, they must:
- Free from any systemic or dermatologic disorder that, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs.
Key exclusion criteria (14 listed)
- 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 skin conditions on the face or bald scalp that in the investigator's opinion would interfere with the study assessments.
- Use within six months prior to randomization of oral isotretinoin.
- Use within six months prior to randomization 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
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 sodiumAlso: SolarazeTopical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days. | Drug | Diclofenac Sodium 3% gel - Reference, Diclofenac Sodium 3% gel - Test |
| PlaceboAlso: Vehicle baseTopical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days. | Other | Placebo gel |
Primary outcome
Percentage of Patients With 100% Clearance of All AK Lesions Within the Treatment Area Assessed at Day 90
Time frame: 90 days
The primary measure of bioequivalence will be evaluated using those patients who complete the study according to the (PP) population.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Henry Lau, PhD study director
Actavis Inc.
31 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 in people with Actinic Keratosis, run by Actavis Inc. at 31 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 11 inclusion and 14 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 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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 20 Jul 2020). 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?
Percentage of Patients With 100% Clearance of All AK Lesions Within the Treatment Area Assessed at Day 90 (time frame: 90 days). 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 20 Jul 2020.