Bioequivalence of Generic Imiquimod Cream, 5% When Compared to Aldara™ (Imiquimod) Cream, 5% in the Treatment of Actinic Keratosis
Actinic Keratoses
Bottom Line
View on ClinicalTrials.gov: NCT00948428 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- imiquimod (Drug); Aldara™ (Drug); Vehicle Cream (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Actavis Inc.
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects in Each Treatment Group With Complete Clearance of AK Lesions at the Test of Cure Visit (Week 24) |
74; 72; 7 | 0.0001 sig |
| SECONDARY Percentage of Subjects With at Least a 75% Reduction in the Number of AK Lesions From Baseline to End of Treatment (EOT) Visit (Week 16). |
110; 114; 14 | — |
| SECONDARY Percentage of Subjects With at Least a 75% Reduction in the Number of AK Lesions From Baseline to 8 Weeks Post Treatment (Test of Cure Visit). |
77; 77; 7 | — |
Summary
Eligibility Criteria
Inclusion Criteria
- Subjects were male or non-pregnant females, 18 years of age or older, in generally good health. Females who were post-menopausal, surgically sterile or using a medically acceptable form of birth control with a negative urine pregnancy test at the Baseline visit.
- Subjects provided written and verbal informed consent.
- Subjects presented to the clinic with at least 4 but no more than 12 visible, discrete nonhyperkeratotic, nonhypertrophic actinic keratosis lesions within a 25 cm2 Treatment Area on the face and/or anterior scalp.
- Subjects were willing and able to comply with study instructions and return to the clinic for required visits.
Exclusion Criteria
- Subjects who were lactating, or planning to become pregnant during the study.
- Subjects had hyperkeratotic, hypertrophic or large mat-like AKs within the 25 cm2 Treatment Area.
- Subjects who had the need or were planning to be exposed to artificial tanning devices or excessive sunlight during the trial.
- Subjects who were immunosuppressed (e.g., HIV, systemic malignancy, graft vs. host disease, etc.).
- Subjects who experienced an unsuccessful outcome from previous imiquimod therapy.
- Subjects with known hypersensitivity or previous allergic reaction to any of the active or inactive components of the study drugs.
- Within 2 months: Facial and/or Anterior Scalp: laser resurfacing, photodynamic therapy, chemical peels, dermabrasion, topical application of 5-FU, imiquimod, diclofenac sodium or other treatments for AK or photodamage.
- Subjects who used the following systemic, oral or topical therapies for the periods specified prior to entry into the study:
Within 2 days: Topicals of any kind to the selected Treatment Area. Within 2 weeks: Facial topical medications: corticosteroids, alpha- hydroxyacids (e.g., glycolic acid, lactic acid, etc. greater than 5%), beta-hydroxyacid (salicylic acid greater than 2%), urea - greater than 5% or prescription retinoids (e.g., tazarotene, adapalene, tretinoin) to the face and/or anterior scalp.
Within 2 weeks: Cryotherapy to lesions adjacent to or within the 25 cm2 Treatment Area.
Within 4 weeks: Systemic steroid therapy: chemotherapeutic agents, psoralens, immunotherapy, or retinoids.
Data sourced from ClinicalTrials.gov (NCT00948428). 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.