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A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis

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ClinicalTrials.gov Identifier: NCT01962987
Recruitment Status : Completed
First Posted : October 16, 2013
Last Update Posted : October 16, 2013
Sponsor:
Information provided by (Responsible Party):
Actavis Inc.

Brief 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

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: Diclofenac sodium Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 585 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : March 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diclofenac Sodium 3% gel - Test
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.
Drug: Diclofenac sodium
Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
Other Name: Solaraze

Active Comparator: Diclofenac Sodium 3% gel - Reference
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.
Drug: Diclofenac sodium
Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
Other Name: Solaraze

Placebo Comparator: Placebo gel
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.
Other: Placebo
Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
Other Name: Vehicle base




Primary Outcome Measures :
  1. Bioequivalence in the Per-Protocol Population by evaluating the 90% CI of the difference between the proportion of patients in the test group and the proportion of patients in the reference group with 100% clearance of all AK [ Time Frame: 90 days ]

    The primary measure of bioequivalence will be evaluated using those patients who complete the study according to the (PP) population. The primary measure of interest is the proportion of patients in the per protocol (PP) population in each treatment group who are considered to have 100% clearance of all the AK lesions within the treatment area, assessed at study day 90 after the 60 days of treatment.

    If the 90% confidence interval (using Yates Correction) of the difference between the proportion of patients considered to have 100% clearance of all AK lesions in the treatment area, assessed 30 days after the end of treatment (Day 90) in the test and the reference product groups is contained within -20%, +20% then bioequivalence will be considered to have been demonstrated.

    The PP population will be used for the primary analysis of bioequivalence.



Secondary Outcome Measures :
  1. In the Modified Intent-to-Treat (mITT) Population, the superiority of the test and reference gels against the placebo will be tested [ Time Frame: 90 days ]
    The mITT population will be used to evaluate the superiority of both the test and reference product to placebo for the proportion of patients showing 100% clearance of AK lesions at Day 90 (30 days after completion of 60 days of treatment) using the mITT study population and LOCF. On condition that the proportion of patients showing 100% clearance in the test and reference groups is statistically significantly greater (p<0.05) than the 100% clearance rate seen in the placebo group then the primary endpoint in the study shall be considered to have been validated.


Other Outcome Measures:
  1. The frequency, severity and relationship to the study drug for adverse events in each treatment group will be used to compare the safety of the study medications [ Time Frame: up to 13 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent form, which meets all criteria of current FDA and HIPAA regulations.
  2. Immunocompetent male or non-pregnant, non-lactating female at least 18 years of age.
  3. 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.
  4. 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:

    1. 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.
    2. Had a normal menstrual cycle for the month prior to the start of treatment.
    3. Have a negative urine pregnancy test result upon entry into the study.
    4. 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.
  5. 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.
  6. Any skin type or race, providing the skin pigmentation will allow discernment of erythema.
  7. Willingness and capability to cooperate to the extent and degree required by the protocol.

Exclusion Criteria:

  1. Active gastrointestinal ulceration or bleeding.
  2. Current or history of severe renal or hepatic impairment.
  3. 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.
  4. Use within six months prior to randomization of oral isotretinoin.
  5. 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
  6. 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.
  7. 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)
  8. Known allergies to diclofenac sodium, benzyl alcohol, polyethylene glycol monomethyl ether 359, hyaluronate sodium or any excipients in the test or reference gels.
  9. Receiving 5-Fluorouracil or other systemic cancer chemotherapy within 6 months prior to randomization.
  10. Any condition, medical, psychological, or social, that, in the Investigator's opinion, would interfere with participation in the study.
  11. Women who are pregnant, planning pregnancy or lactating.
  12. Participation in any investigational drug study within 30 days of randomization or previous participation in this study.
  13. Employees of the research center or Investigator.
  14. Family members of employees of the research center or Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01962987


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Sponsors and Collaborators
Actavis Inc.
Investigators
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Study Director: Henry Lau, PhD Actavis Inc.

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Responsible Party: Actavis Inc.
ClinicalTrials.gov Identifier: NCT01962987     History of Changes
Other Study ID Numbers: 71204901
First Posted: October 16, 2013    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Diclofenac
Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action