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OpenTrials
Completed

NCT Number: NCT00828568

Bioequivalence Study of Two Imiquimod Cream 5%

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.

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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigator Site, Gilbert, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. 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.

  2. 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

  1. Patients Reporting at Least One Adverse Event

    Time frame: 24 weeks

    For all patients who received a single dose, adverse events were collected at each follow-up visit. Any patient reporting a single or multiple adverse events at any visit was conisdered to have had at least one adverse event.

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Two Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 26, 2009
Registry last updated
Jan 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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