Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients

NCT02866695 | Completed Phase 4 Results

• 1 other identifier: Leo AK
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm, open-label interventional study of ingenol mebutate 0.015% in solid organ transplant recipients. The investigators plan to treat 20 subjects, 10 kidney transplant recipients and 10 lung transplant recipients. The investigators have selected these two populations as the represent the spectrum of solid organ transplantation: kidney transplant recipients are the largest transplant population, but have lower levels of immunosuppression and skin cancer risk. Lung transplant recipients have the highest burden of skin cancer and actinic keratoses.

Conditions

Actinic Keratosis

Keywords

Actinic Keratosis; lung transplant; kidney transplant

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  To evaluate the safety of ingenol mebutate gel 0.015% on the face in solid organ transplant recipients

  From screening to Day 57 or study early termination if applicable

Secondary Outcomes (2)

• Number of Participants With a Reduction of Actinic Keratosis

  Day 57 (assessed at screening, day 1, day 29, day 57, and study early termination if applicable, clearance at day 57 reported)

• Participant's Local Skin Response Grading Scale

  Day 1, Day 4 (assessed at screening, day 1, day 4, day 29, day 57, and study early termination if applicable, results at day 1 and day 4 reported)

Study Arms (1)

Open label treatment

OTHER

All patients will be treated with ingenol mebutate gel 0.015%. There is no placebo or comparator for this study. The investigator will identify the patient's treatment area at Baseline, and provide a detailed application instruction sheet. The first dose will be applied in clinic under the supervision of the investigator.

Drug: ingenol mebutate gel 0.015%

Interventions

ingenol mebutate gel 0.015% DRUG

ingenol mebutate gel 0.015% to be applied on treatment area

Also known as: Picato

Open label treatment

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.
• Subject must be a solid organ transplant recipient at least one year from the date of transplantation.
• Subjects must be in stable health as confirmed by medical history, per investigator judgement.
• Subjects must be able to read, sign, and understand the informed consent.
• Subjects have at least 4 and no more than 20 clinically typical (non-hyperkeratotic/hypertrophic), visible actinic keratoses in a treatment area of approximately 100cm2 on the face. Treatment areas will include a single cheek (nasofacial sulcus to tragus, malar cheekbone to jawline and avoiding the lower eyelid and mouth); the forehead (hairline to eyebrows, extending laterally to the root of the helix).
• Subject must be willing to forego any other treatments on the face, including cryotherapy, tanning bed use and excessive sun exposure while in the study.
• Subject is willing and able to participate in the study 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 an unstable medical condition as deemed by the clinical investigator.
• Subjects with a history of bone marrow or stem cell transplantation.
• Subjects with non-melanoma skin cancer on the face.
• Subjects with hyperkeratotic or hypertrophic AKs.
• 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.
• Women who are pregnant, lactating, or planning to become pregnant during the study period.
• Subjects who have previously been treated with ingenol mebutate in study area within the past 8 weeks.
• Subjects who have used any topical prescription medications for actinic keratosis on the study area within 8 weeks prior to study treatment initiation.
• Subjects who have used any topical prescription medications for other reason on the study area within 4 weeks prior to study treatment initiation.
• 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 with known hypersensitivity to Picato gel or any of the inactive ingredients: isopropyl alcohol, hydroxyethyl cellulose, citric acid monohydrate, sodium citrate, or benzyl alcohol.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Dermatology

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

3-ingenyl angelate

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Sarah Arron, MD, PhD
• Organization: University of California San Francisco Dept. of Dermatology

sarah.arron@ucsf.edu

415-353-9684

Study Officials

• Sarah Arron, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 15, 2016
• Study Start: October 6, 2016
• Primary Completion: July 2, 2018
• Study Completion: July 2, 2018
• Last Updated: March 9, 2022
• Results First Posted: February 25, 2019

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)