Efficacy and Safety of a New Topical Formulation With Imiquimod (Limtop) Applied 1, 3 or 7 Times Weekly During 2 x 2 Weeks Treatment for Actinic Keratosis on the Head

NCT01611480 | Completed Phase 2

• 1 other identifier: LIMTOP-I
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to evaluate efficacy and safety of three different dosing regimens of Limtop in a study involving 96 patients with actinic keratosis on the head or face.

Conditions

Actinic Keratosis

Interventions

Imiquimod (topical use) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent form (ICF) signed and dated by the patient prior to any study-related activity
• Male or female patients aged 18 or older
• Have a total of 5-20 clinically confirmed, palpable or visible (grade I or II according to modified Olsen score) nonhyperkeratotic, nonhypertrophic AK lesions located within a contiguous 25 - 100 cm² area on the balding scalp or face
• Any skin type or race, providing the skin pigmentation will allow discernment of erythema
• Willingness to actively participate in the study and to comply with the study procedures as defined in the study protocol
• High probability of a good compliance and orderly completion of the study
• Negative urine pregnancy test (in female subjects with childbearing potential)

You may not qualify if:

• Evidence of clinically significant, unstable cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease
• Diagnosed autoimmune diseases and anaemia
• Any dermatological disease and or condition in the treatment or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination (e.g. rosacea, psoriasis, atopic dermatitis, eczema)
• Any significant findings (e.g. tattoos) in the potential application site area that may impair examination of treatment or surrounding area
• Confirmed squamous cell or basal cell carcinoma anywhere on the head in the past 3 months
• Share a household where there is a person participating in a concurrent clinical study of imiquimod or being treated with imiquimod 5% topical cream
• Active chemical dependency or alcoholism, as assessed by investigator
• Patients unwilling to stay out of the sun or wear protective clothing or to take appropriate measures to cover the treatment area during the study
• Previous treatments with imiquimod for AK in the predetermined treatment area within the past 3 months
• Treatment with COX-2 inhibitors 14 days prior to randomization
• 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
• Subjects who experienced an unsuccessful outcome from previous imiquimod therapy.
• Known allergy or sensitivity to imiquimod or any of the excipients (butyl lactate, isopropyl myristate, propylene glycol, butylated hydroxy anisole) in the IMP
• Pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active women who:
• are pregnant or nursing,

Sponsors & Collaborators

• Moberg Pharma AB: lead

Study Sites (1)

5 Locations

Germany, Germany

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2012
• First Posted: June 5, 2012
• Primary Completion: January 1, 2013
• Last Updated: June 26, 2013

Record last verified: 2013-06

Locations

DE (1)