--- title: Bioequivalence Study of Two Imiquimod Cream 5% nct_id: NCT00828568 overall_status: COMPLETED phase: PHASE1 sponsor: Sun Pharmaceutical Industries, Inc. study_type: INTERVENTIONAL primary_condition: Actinic Keratosis countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00828568.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00828568" ct_last_update_post_date: 2014-01-28 last_seen_at: "2026-05-12T06:51:05.685Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Bioequivalence Study of Two Imiquimod Cream 5% **Official Title:** A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Two Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis **NCT ID:** [NCT00828568](https://clinicaltrials.gov/study/NCT00828568) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE1 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 425 - **Lead Sponsor:** Sun Pharmaceutical Industries, Inc. - **Conditions:** Actinic Keratosis - **Start Date:** 2008-06 - **Completion Date:** 2009-05 - **CT.gov Last Update:** 2014-01-28 ## 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 superiority over vehicle in the treatment of AK. The secondary objective is to compare the adverse event (AE) profiles of the two creams. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **Imiquimod 5% Taro** (EXPERIMENTAL) — Imiquimod 5% manufactured by Taro applied for 16 weeks - **Aldara - Imiquimod 5%** (ACTIVE_COMPARATOR) — Aldara, Imiquimod 5% applied for 16 weeks - **Vehicle** (PLACEBO_COMPARATOR) — Imiquimod vehicle applied for 16 weeks ## Interventions - **Imiquimod 5% manufactured by Taro** (DRUG) — Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks - **Aldara - Imiquimod 5%** (DRUG) — Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks - **Imiquimod Vehicle manufactured by Taro** (DRUG) — Treatment applied as a thin layer to target area once daily, 2 days each week, for 16 weeks ## Primary Outcomes - **Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5%** _(time frame: 24 weeks)_ — Uses per protocol (PP) population. Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions. - **Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline** _(time frame: 24 weeks)_ — Uses ITT population. Three patients (1 Imiquimod 5% Taro and 2 Imiquimod Aldara) did not have a follow-up visit after dosing and were excluded from ITT. Three patients (2 Imiquimod 5% Taro and 1 Imiquimod Aldara) were not evaluable at the 24-week visit and were not in the analysis. Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions. ## Secondary Outcomes - **Patients Reporting at Least One Adverse Event** _(time frame: 24 weeks)_ ## Locations (20) - Investigator Site, Gilbert, Arizona, United States - Investigator Site, Tempe, Arizona, United States - Investigator Site, Tuscon, Arizona, United States - Investigator Site, Denver, Colorado, United States - Investigator Site, Jacksonville, Florida, United States - Investigator Site, Miami, Florida, United States - Investigator Site, Evansvill, Indiana, United States - Investigator Site, Plainfield, Indiana, United States - Investigator Site, Olathe, Kansas, United States - Investigator Site, Wichita, Kansas, United States - Investigator Site, Omaha, Nebraska, United States - Investigator Site, Henderson, Nevada, United States - Investigator Site, Cary, North Carolina, United States - Investigator Site, Hickory, North Carolina, United States - Investigator Site, High Point, North Carolina, United States - Investigator Site, Winston-Salem, North Carolina, United States - Investigator Site, Simpsonville, South Carolina, United States - Investigator Site, Murfreesboro, Tennessee, United States - Investigator Site, College Station, Texas, United States - Investigator Site, Tyler, Texas, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.investigator site|gilbert|arizona|united states` — added _(2026-05-12)_ - `locations.investigator site|tempe|arizona|united states` — added _(2026-05-12)_ - `locations.investigator site|tuscon|arizona|united states` — added _(2026-05-12)_ - `locations.investigator site|denver|colorado|united states` — added _(2026-05-12)_ - `locations.investigator site|jacksonville|florida|united states` — added _(2026-05-12)_ - `locations.investigator site|miami|florida|united states` — added _(2026-05-12)_ - `locations.investigator site|evansvill|indiana|united states` — added _(2026-05-12)_ - `locations.investigator site|plainfield|indiana|united states` — added _(2026-05-12)_ - `locations.investigator site|olathe|kansas|united states` — added _(2026-05-12)_ - `locations.investigator site|wichita|kansas|united states` — added _(2026-05-12)_ - `locations.investigator site|omaha|nebraska|united states` — added _(2026-05-12)_ - `locations.investigator site|henderson|nevada|united states` — added _(2026-05-12)_ - `locations.investigator site|cary|north carolina|united states` — added _(2026-05-12)_ - `locations.investigator site|hickory|north carolina|united states` — added _(2026-05-12)_ - `locations.investigator site|high point|north carolina|united states` — added _(2026-05-12)_ - `locations.investigator site|winston-salem|north carolina|united states` — added _(2026-05-12)_ - `locations.investigator site|simpsonville|south carolina|united states` — added _(2026-05-12)_ - `locations.investigator site|murfreesboro|tennessee|united states` — added _(2026-05-12)_ - `locations.investigator site|college station|texas|united states` — added _(2026-05-12)_ - `locations.investigator site|tyler|texas|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00828568.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00828568* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*