NCT00828568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
425

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
7 months until next milestone

Results Posted

Study results publicly available

November 26, 2009

Completed
Last Updated

January 28, 2014

Status Verified

December 1, 2013

Enrollment Period

9 months

First QC Date

January 22, 2009

Results QC Date

September 17, 2009

Last Update Submit

December 21, 2013

Conditions

Actinic Keratosis

Keywords

Actinic Keratosis

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5%

    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.

    24 weeks

  • Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline

    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.

    24 weeks

Secondary Outcomes (1)

  • Patients Reporting at Least One Adverse Event

    24 weeks

Study Arms (3)

Imiquimod 5% Taro

EXPERIMENTAL

Imiquimod 5% manufactured by Taro applied for 16 weeks

Drug: Imiquimod 5% manufactured by Taro

Aldara - Imiquimod 5%

ACTIVE COMPARATOR

Aldara, Imiquimod 5% applied for 16 weeks

Drug: Aldara - Imiquimod 5%

Vehicle

PLACEBO COMPARATOR

Imiquimod vehicle applied for 16 weeks

Drug: Imiquimod Vehicle manufactured by Taro

Interventions

Imiquimod 5% manufactured by TaroDRUG

Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks

Imiquimod 5% Taro
Aldara - Imiquimod 5%DRUG

Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks

Aldara - Imiquimod 5%
Imiquimod Vehicle manufactured by TaroDRUG

Treatment applied as a thin layer to target area once daily, 2 days each week, for 16 weeks

Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Investigator Site

Gilbert, Arizona, United States

Location

Investigator Site

Tempe, Arizona, United States

Location

Investigator Site

Tuscon, Arizona, United States

Location

Investigator Site

Denver, Colorado, United States

Location

Investigator Site

Jacksonville, Florida, United States

Location

Investigator Site

Miami, Florida, United States

Location

Investigator Site

Evansvill, Indiana, United States

Location

Investigator Site

Plainfield, Indiana, United States

Location

Investigator Site

Olathe, Kansas, United States

Location

Investigator Site

Wichita, Kansas, United States

Location

Investigator Site

Omaha, Nebraska, United States

Location

Investigator Site

Henderson, Nevada, United States

Location

Investigator Site

Cary, North Carolina, United States

Location

Investigator Site

Hickory, North Carolina, United States

Location

Investigator Site

High Point, North Carolina, United States

Location

Investigator Site

Winston-Salem, North Carolina, United States

Location

Investigator Site

Simpsonville, South Carolina, United States

Location

Investigator Site

Murfreesboro, Tennessee, United States

Location

Investigator Site

College Station, Texas, United States

Location

Investigator Site

Tyler, Texas, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Medical Director
Organization
Taro Pharmaceuticals USA
medical.affairs@taro.com
(914) 345-9001

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 26, 2009

Study Start

June 1, 2008

Primary Completion

March 1, 2009

Study Completion

May 1, 2009

Last Updated

January 28, 2014

Results First Posted

November 26, 2009

Record last verified: 2013-12

Locations

US(20)