Trial intelligence / Profile preview

AD17137 in Facial Actinic Keratosis

NCT01921907Phase 2

Key facts

Status
Completed
Start
Jul 2013
Primary completion
Jun 2014
Countries
1
Modality
Small Molecules
Conditions
actinic keratosis (AK)
01

Overview

Phase 2, randomised, double-blind trial of AD-17137 in actinic keratosis (AK) (2 arms), sponsored by Assuta Medical Centers. Primary endpoint: Complete Clearance (100% of AK lesions) at 7 weeks. Started Jul 2013; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Active Arm

    AD17137 topical treatment for 7 weeks

  • Placebo Arm

    Placebo topical treatment for 4 weeks, followed by AD17137 topical treatment for 3 weeks

03

Who it enrols

Patients aged 30-90 with a clinical diagnosis of Actinic Keratosis and at least 2 clinically diagnosed, 3-15 mm AK lesions on the face or scalp, excluding those with recent specific topical or systemic treatments, hereditary angio-edema, epilepsy, Parkinson's disease, or immunodeficiency disorders.

04

Endpoints

Primary

  • Complete Clearance (100% of AK lesions)

Secondary

  • Partial Clearance (75% of AK lesions)

  • Mean change in lesion size

  • Change in Investigator Global Assessment

  • Mean change in lesion number

  • Change in Patient Global Assessment

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