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Also known as Imiquimod Cream, 3.75%
Imiquimod, 3.75% · 1 trial · 1 indication
The primary efficacy endpoint is the proportion of subjects with treatment success at Visit 5/Week 14 (8 weeks post-treatment). Treatment success is defined as 100% clearance of all AK lesions (baseline AK lesions and any new AK lesions) within the treatment area.
| Arm | Type | Description |
|---|---|---|
| Investigational Test Product | EXPERIMENTAL | Imiquimod Cream, 3.75% (Teva) |
| Reference Listed Drug | ACTIVE_COMPARATOR | Zyclara® (imiquimod Cream), 3.75% (Medicis) |
| Vehicle | PLACEBO_COMPARATOR | Vehicle of Test Product (Teva) |
| Name | Type | Description |
|---|---|---|
| Imiquimod Cream, 3.75% | DRUG | - |
| Zyclara® | DRUG | - |
| Vehicle of Test Product | OTHER | - |
Inclusion Criteria: * Willing and able to provide written informed consent for the study * At least 18 years of age. * Immunocompetent male or non-pregnant and non-lactating female. Each female subject of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at...
Imiquimod, 3.75% is a topical small molecule being developed for the treatment of actinic keratosis, a skin condition caused by sun damage. It is applied directly to the skin. Teva Pharmaceutical Industries Limited is developing it as a Phase 3 candidate in dermatology.
Imiquimod, 3.75% targets TLR7, also known as Toll-like receptor 7, and acts as an agonist at that receptor. TLR7 agonism triggers a local immune response in the skin, which is the basis for its activity against actinic keratosis lesions.
Imiquimod, 3.75% is being developed by Teva Pharmaceutical Industries Limited, which trades on the Nasdaq under the ticker TEVA. Teva is the sponsor of the clinical program evaluating this topical formulation for actinic keratosis.
Imiquimod, 3.75% is in Phase 3 development for actinic keratosis. It is an investigational product and is not approved by the FDA for this use. The Phase 3 trial in the program has been completed, and no trials are currently active.
Imiquimod, 3.75% has been studied in one Phase 3 trial, NCT01686152, titled a study comparing imiquimod cream, 3.75% to Zyclara (imiquimod) cream, 3.75% in the treatment of actinic keratosis. The trial enrolled 589 participants in the United States and is completed.
Yes. Imiquimod, 3.75% and imiquimod cream, 3.75% refer to the same product, a 3.75% topical formulation of imiquimod. The alternative name reflects the cream dosage form used in the Phase 3 actinic keratosis program.