Ingenol Mebutate Compared to Cryotherapy for the Treatment of Skin Lesions

NCT01735942 | Withdrawn Early Phase 1 DMC

• 1 other identifier: STU68227
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in visual assessment scores at 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.

  Baseline and 3 months

Study Arms (2)

Ingenol Mebutate

EXPERIMENTAL

Ingenol Mebutate applied to one side of face with skin lesions

Drug: Ingenol mebutate

Cryotherapy

ACTIVE COMPARATOR

Cryotherapy applied to other side of face with skin lesions

Procedure: cryotherapy

Interventions

Ingenol mebutate DRUG

Ingenol Mebutate

cryotherapy PROCEDURE

Cryotherapy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

3-ingenyl angelate; Cryotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation

Study Record Dates

• First Submitted: November 5, 2012
• First Posted: November 28, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: December 6, 2021

Record last verified: 2021-12