Actinic KeratosisPhase 1NCT01742663
A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® Gel 3% in the Treatment of Actinic Keratosis
A Phase 1 study testing Diclofenac Sodium Gel 3% and Solaraze® (diclofenac sodium) Gel 3% in people with Actinic Keratosis, run by Sun Pharmaceutical Industries, Inc..
Trial summary
The objective of this study is to compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3% (Taro Pharmaceuticals Inc.) to the marketed formulation Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms) 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?
- Diclofenac Sodium Gel 3% and Solaraze® (diclofenac sodium) Gel 3%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 435 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Oct 2013
- Phase
- Phase 1
- 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 informed consent form.
- Immunocompetent male or non-pregnant, non-lactating female at least 18 years of age.
- Diagnosis of AK with at least 5 and no more than 10 clinically typical, visable, discrete, nonhyperkeratotic, nonhypertrophic AK lesions each at least 4 mm in diameter on the face and/or bald scalp contained within a 25 cm2 treatment area.
- Women either must be 1 year post-menopausal, 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 treatment start, or used barrier methods consistently at least 14 days before study gel administration, had a normal menstrual cycle for the month prior to the start of treatment, have a negative urine pregnancy test result upon entry into the study and agree to use a medically accepted form of birth control 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 risks 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 confounding skin conditions on the face or bald scalp.
- Use within six months prior to randomization of oral isotretinoin.
- Use within six months prior to baseline on the face or bald scalp of chemical peel, dermabrasion, laser abrasion, PUVA therapy or UVB therapy.
- Use within one month prior to baseline on the face or bald scalp of cryodestruction or chemodestruction, curettage, photodynamic therapy, surgical excision, topical 5-fluorouracil, topical corticosteroids, topical diclofenac, topical Imiquimod, topical retinoids or 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 baseline of immunomodulators or immunosuppressive therapies, interferon, systemic corticosteroids or cytotoxic drugs.
- 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 study entry.
- Any condition, medical, psychological or social, that, in the investigator's opinion, would interfere with participation in the study.
- Women who are pregnant or planning pregnancy or lactating during the study.
- Participation in any investigational drug study within 30 days of enrollment or previous participation in this study.
- Employees or family members of employees of the research center or investigator.
About this study
Official title: A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design Study Comparing Diclofenac Sodium Gel 3% (Taro Pharmaceuticals Inc.) to Solaraze® (Diclofenac Sodium) Gel 3% (Fougera Pharms) in the Treatment of Actinic Keratosis.
The objective of this study is to compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3% (Taro Pharmaceuticals Inc.) to the marketed formulation Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms) in the treatment of actinic keratosis.
Both the test and reference formulations will also be compared to a placebo formulation to test for superiority.
- Conditions
- Actinic Keratosis
- Being tested
- Diclofenac Sodium Gel 3%, Solaraze® (diclofenac sodium) Gel 3%, Vehicle Topical Gel
- Keywords
- Diclofenac Sodium Gel 3%, Solaraze® (diclofenac sodium) Gel 3%, Actinic Keratosis
- 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 Gel 3%Drug
Diclofenac Sodium Gel 3% (Taro Pharmaceuticals Inc.) applied twice daily for 60 days.
Solaraze® (diclofenac sodium) Gel 3%Drug
Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms)applied twice daily for 60 days.
Vehicle Topical GelDrug
Vehicle Topical Gel (Taro Pharmaceuticals Inc.) applied twice daily for 60 days.
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac Sodium Gel 3% | Experimental | Diclofenac Sodium Gel 3% (Taro Pharmaceuticals Inc.) Receives: Drug: Diclofenac Sodium Gel 3% |
| Solaraze® (diclofenac sodium) Gel 3% | Active comparator | Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms) Receives: Drug: Solaraze® (diclofenac sodium) Gel 3% |
| Vehicle Topical Gel | Placebo comparator | Vehicle Topical Gel (Taro Pharmaceuticals Inc.) Receives: Drug: Vehicle Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Bioequivalence will be determined by evaluating the proportion of patients in the test and reference groups with 100% clearance of all AK lesions in the treatment area.
Measured: Study day 90 (30 days after completion of 60 days of treatment)
Secondary outcomes (1)
Superiority to placebo
The superiority of the test and reference gels against the placebo will be tested by the proportion of patients showing 100% clearance of actinic keratosis lesions at Day 90 (30 days after completion of 60 days of treatment)using the modified intent to treat population and last observation carried forward.
Measured: Study 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.
- First posted5 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742663
- Sponsor's protocol ID
- DCSG 1213
- Status last verified
- Jan 2014
- First submitted
- 3 Dec 2012
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. 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% (Taro Pharmaceuticals Inc.) to Solaraze® (Diclofenac Sodium) Gel 3% (Fougera Pharms) in the Treatment of Actinic Keratosis.
- ClinicalTrials.gov ID
- NCT01742663
- Acronym / sponsor ID
- DCSG 1213
- Conditions
- Actinic Keratosis
- Keywords
- Diclofenac Sodium Gel 3%, Solaraze® (diclofenac sodium) Gel 3%, Actinic Keratosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 5 Dec 2012 (estimated)
- 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.
The objective of this study is to compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3% (Taro Pharmaceuticals Inc.) to the marketed formulation Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms) in the treatment of actinic keratosis.
Both the test and reference formulations will also be compared to a placebo formulation to test for superiority.
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 Gel 3% | Experimental | Drug: Diclofenac Sodium Gel 3%Diclofenac Sodium Gel 3% (Taro Pharmaceuticals Inc.) |
| Solaraze® (diclofenac sodium) Gel 3% | Active comparator | Drug: Solaraze® (diclofenac sodium) Gel 3%Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms) |
| Vehicle Topical Gel | Placebo comparator | Drug: Vehicle Topical GelVehicle Topical Gel (Taro Pharmaceuticals Inc.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent form.
- Immunocompetent male or non-pregnant, non-lactating female at least 18 years of age.
- Diagnosis of AK with at least 5 and no more than 10 clinically typical, visable, discrete, nonhyperkeratotic, nonhypertrophic AK lesions each at least 4 mm in diameter on the face and/or bald scalp contained within a 25 cm2 treatment area.
- Women either must be 1 year post-menopausal, 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 treatment start, or used barrier methods consistently at least 14 days before study gel administration, had a normal menstrual cycle for the month prior to the start of treatment, have a negative urine pregnancy test result upon entry into the study and agree to use a medically accepted form of birth control 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 risks of AEs.
Key exclusion criteria (13 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 confounding skin conditions on the face or bald scalp.
- Use within six months prior to randomization of oral isotretinoin.
- Use within six months prior to baseline on the face or bald scalp of chemical peel, dermabrasion, laser abrasion, PUVA therapy or 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 Sodium Gel 3%Diclofenac Sodium Gel 3% (Taro Pharmaceuticals Inc.) applied twice daily for 60 days. | Drug | Diclofenac Sodium Gel 3% |
| Solaraze® (diclofenac sodium) Gel 3%Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms)applied twice daily for 60 days. | Drug | Solaraze® (diclofenac sodium) Gel 3% |
| Vehicle Topical GelVehicle Topical Gel (Taro Pharmaceuticals Inc.) applied twice daily for 60 days. | Drug | Vehicle Topical Gel |
Primary outcome
Bioequivalence
Time frame: Study day 90 (30 days after completion of 60 days of treatment)
Bioequivalence will be determined by evaluating the proportion of patients in the test and reference groups with 100% clearance of all AK lesions in the treatment area.
1 secondary outcome
Superiority to placebo
Time frame: Study day 90 (30 days after completion of 60 days of 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 22 Jan 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Diclofenac Sodium Gel 3% and Solaraze® (diclofenac sodium) Gel 3% in people with Actinic Keratosis, run by Sun Pharmaceutical Industries, Inc..
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 7 inclusion and 13 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 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Bioequivalence (time frame: Study 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?
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 22 Jan 2014.