Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryotherapy in the Hypertrophic Actinic Keratoses

NCT02251652 | Completed Phase 4 Results DMC

• 1 other identifier: GCO 13-0142
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Sequential therapy with cryosurgery and ingenol mebutate may optimize the treatment of hypertrophic AKs and also treat non-hypertrophic AKs in this anatomic location. Furthermore, use of ingenol mebutate will also be evaluated for potential treatment of subclinical lesions.

Conditions

Actinic Keratoses

Keywords

Actinic

Outcome Measures

Primary Outcomes (1)

• Safety of Combination Therapy vs Cryotherapy Alone

  To evaluate the safety of cryotherapy plus ingenol mebutate on dorsal hands and compare it to the safety of cryotherapy alone looking at Adverse Events.

  Day 57

Secondary Outcomes (2)

• Change in Number of All Actinic Keratoses

  Baseline and Day 57

• Change in Actinic Keratoses by Anatomic Site

  Baseline and Day 57

Study Arms (2)

Combination Therapy

ACTIVE COMPARATOR

Cryotherapy followed by Ingenol Mebutate Gel

Drug: Ingenol Mebutate; Procedure: Cryotherapy

Cryotherapy Alone

ACTIVE COMPARATOR

Cryotherapy only

Procedure: Cryotherapy

Interventions

Ingenol Mebutate DRUG

Ingenol mebutate 0.05% gel

Also known as: PEP005 Gel

Combination Therapy

Cryotherapy PROCEDURE

1-2 sprays, 5 seconds each, with a 5 second interval

Combination Therapy; Cryotherapy Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults at least 18 years old.
• Subjects must be in good general health as confirmed by the medical history.
• Subjects must be able to read, sign, and understand the informed consent
• Prior to cryosurgery, subjects have at least 3 hypertrophic actinic keratoses on each dorsal hand.
• Subject must be willing to forego any other treatments on the dorsum of the hands, including tanning bed use and excessive sun exposure while in the study.
• Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods and to comply with all study requirements including concomitant medication and other treatment restrictions.
• If subject is a female of childbearing potential she must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study.

You may not qualify if:

• Subjects with a history of melanoma anywhere on the body.
• Subjects with an unstable medical condition as deemed by the clinical investigator.
• Subjects with non-melanoma skin cancer on the dorsum of the hands.
• Subjects with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of AKs.
• Subjects who have previously been treated with ingenol mebutate: on the dorsum of the hands in the past 6 months; or outside of the study area within the past 30 days.
• Women who are pregnant, lactating, or planning to become pregnant during the study period.
• Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc).
• Subjects who have active chemical dependency or alcoholism as assessed by the investigator.
• Subjects who have known allergies to any excipient in the study gel.
• Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device on the study area within 30 days prior to study treatment initiation.
• Subjects who have received any of the following within 90 days prior to study treatment initiation:
• interferon or interferon inducers
• cytotoxic drugs
• immunomodulators or immunosuppressive therapies (inhaled/ intranasal steroids are permitted)
• oral or parenteral corticosteroids

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• LEO Pharma: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 11370, United States

Location

Related Publications (1)

• Hashim PW, Nia JK, Singer S, Goldenberg G. An Investigator-initiated Study to Assess the Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryosurgery in the Treatment of Hypertrophic Actinic Keratosis on Dorsal Hands. J Clin Aesthet Dermatol. 2016 Jul;9(7):16-22. Epub 2016 Jul 1.

  PMID: 27672408 DERIVED

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

Limitations and Caveats

Study limitations include small sample size and the fact that LSRs may unblind the investigator.

Results Point of Contact

• Title: Dr. Gary Goldenberg
• Organization: Icahn School of Medicine at Mount Sinai

garygoldenbergmd@gmail.com

212-241-9728

Study Officials

• Gary Goldenberg, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: September 29, 2014
• Study Start: April 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: August 1, 2015
• Last Updated: April 26, 2017
• Results First Posted: April 26, 2017

Record last verified: 2017-03

Locations

US (1)