Status:
COMPLETED
Bioequivalence Study of Two Imiquimod Cream 5%
Lead Sponsor:
Sun Pharmaceutical Industries, Inc.
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Taro Pharmaceuticals Inc. and Aldara (imiquimod) cream, manufactured by 3M, and to show super...
Eligibility Criteria
Inclusion
- Patients must have 4 to 8 clinically diagnosed, non-hyperkeratotic, non-hypertrophic AK lesions within a 25 cm2 contiguous treatment area on either the face or balding scalp
- Women either must be 1 year post-menopausal, surgically sterile, or agree to use a medically accepted form or birth control
- Free of any systemic or dermatological disorder
- Any skin type or race, providing the skin pigmentation will allow discernment of erythema
Exclusion
- Basal cell or squamous cell carcinoma, or other possible confounding skin conditions (on face and scalp)
- History of cutaneous hyperreactivity or facial irritation to topical products
- Engaging in activities involving excessive or prolonged exposure to sunlight
- Receiving systemic cancer chemotherapy, psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion, glycolic acids, or chemical peels 6 months prior to study entry
- Currently using or have used systemic steroids 2 months prior to study
- Currently using or have used on the treatment area over-the-counter retinol products, corticosteroids, cryosurgery, curettage, 5-fluorouracil, or other topical actinic keratosis treatments 28 days prior to randomization
- Pregnant or nursing mothers
- History of allergy or sensitivity to imiquimod or related compounds or other components of the formulation
- Taking immunosuppressant medication
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
425 Patients enrolled
Trial Details
Trial ID
NCT00828568
Start Date
June 1 2008
End Date
May 1 2009
Last Update
January 28 2014
Active Locations (20)
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1
Investigator Site
Gilbert, Arizona, United States
2
Investigator Site
Tempe, Arizona, United States
3
Investigator Site
Tuscon, Arizona, United States
4
Investigator Site
Denver, Colorado, United States