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

A

Apotex

Status and phase

Completed
Phase 3

Conditions

Actinic Keratosis

Treatments

Drug: Adara 5% Cream US
Drug: Imiquimod 5%: manufactured by Apotex
Drug: Adara 5% Cream Canada
Drug: Imiquimod Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT00859105
IMIQ-TOCR-01RB01-CE

Details and patient eligibility

About

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Bio-equivalence Study

Enrollment

497 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

497 participants in 4 patient groups, including a placebo group

Imiquimod 5%
Experimental group
Description:
Manufactured by Apotex
Treatment:
Drug: Imiquimod 5%: manufactured by Apotex
Adara 5 % Cream US
Active Comparator group
Description:
Manufactured by 3M, US.
Treatment:
Drug: Adara 5% Cream US
Adara 5% Cream Canada
Active Comparator group
Description:
Manufactured by 3M, Canada
Treatment:
Drug: Adara 5% Cream Canada
Vehicle
Placebo Comparator group
Description:
Manufactured by Apotex
Treatment:
Drug: Imiquimod Vehicle

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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