Phase 1
N=425
Bioequivalence Study of Two Imiquimod Cream 5%
Actinic Keratosis
Bottom Line
View on ClinicalTrials.gov: NCT00828568 ↗Enrolled (actual)
425
Serious AEs
2.6%
Results posted
Nov 2009
Primary outcome: Primary: Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5% — 63; 54 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Imiquimod 5% manufactured by Taro (Drug); Aldara - Imiquimod 5% (Drug); Imiquimod Vehicle manufactured by Taro (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sun Pharmaceutical Industries, Inc.
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5% |
63; 54 | — |
| PRIMARY Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline |
74; 64; 6 | <0.0001 sig |
| SECONDARY Patients Reporting at Least One Adverse Event |
69; 57; 15 | — |
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 superiority over vehicle in the treatment of AK.
The secondary objective is to compare the adverse event (AE) profiles of the two creams.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00828568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.