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Ingenol Mebutate Compared to Cryotherapy for the Treatment of Skin Lesions

Sponsor
Northwestern University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01735942
Collaborator
(none)
0
Enrollment
2
Arms
43
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ingenol mebutate
  • Procedure: cryotherapy
 Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Comparison of Ingenol Mebutate and Cryotherapy for Treatment of Actinic Keratoses.
Study Start Date :
Oct 1, 2012
Anticipated Primary Completion Date :
May 1, 2016
Anticipated Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ingenol Mebutate

Ingenol Mebutate applied to one side of face with skin lesions

Drug: Ingenol mebutate
Active Comparator: Cryotherapy

Cryotherapy applied to other side of face with skin lesions

Procedure: cryotherapy

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in visual assessment scores at 3 months [Baseline and 3 months]

    The visual assessment evaluates seven clinical signs: erythema, edema, wheal vesiculation, ulceration, hemorrhage, purpura, and crusting. Each sign is assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a better outcome, and a score of 3 is associated with severe expression of the clinical sign and a worse outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Northwestern University

Investigators

  • Principal Investigator: Murad Alam, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Murad Alam, Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier:
NCT01735942
Other Study ID Numbers:
  • STU68227
First Posted:
Nov 28, 2012
Last Update Posted:
Dec 6, 2021
Last Verified:
Dec 1, 2021
Additional relevant MeSH terms:
Keratosis, Actinic
Keratosis

Study Results

No Results Posted as of Dec 6, 2021