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Ingenol Mebutate Compared to Cryotherapy for the Treatment of Skin Lesions

NCT ID: NCT01735942

Last Updated: 2021-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-05-31

Brief Summary

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The purpose of this study is to find out the effectiveness of ingenol mebutate compared to cryotherapy (freezing of the tissue) for the treatment of face and scalp skin lesions.

Detailed Description

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Conditions

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Actinic Keratosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ingenol Mebutate

Ingenol Mebutate applied to one side of face with skin lesions

Group Type EXPERIMENTAL

Ingenol mebutate

Intervention Type DRUG

Cryotherapy

Cryotherapy applied to other side of face with skin lesions

Group Type ACTIVE_COMPARATOR

cryotherapy

Intervention Type PROCEDURE

Interventions

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Ingenol mebutate

Intervention Type DRUG

cryotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male and female subjects between 18 and 89 years old.
* Have at least a total of 10 non-hypertrophic actinic keratoses (AKs) on the face and scalp
* The subjects are in good health
* The subjects have the willingness and the ability to understand and provide informed consent for the use of their tissue and are able to communicate with the investigator

Exclusion Criteria

* Subjects under 18 years of age and over the age of 89
* Subjects who are pregnant or lactating
* Subjects with sensitivity to cold
* Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry
* Subjects who received previous treatment of target AKs
* Subjects whose target treatment area was within 5 cm of an incompletely healed wound or within 10 cm of a suspected basal-cell or squamous-cell carcinoma
* Subjects with use of medications or other treatments that could interfere with evaluation of the treatment area within 2 months before study entry (e.g., topical medications, artificial tanners, immunosuppressive medications, immunomodulating agents, cytotoxic drugs, ultraviolet B phototherapy, other therapies for actinic keratoses, or oral retinoids)
* Subjects who are unable to understand the protocol or to give informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Murad Alam

Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Countries

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United States

Other Identifiers

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STU68227

Identifier Type: -

Identifier Source: org_study_id