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

Primary Purpose

Actinic Keratosis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

ingenol mebutate gel 0.015%

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring Actinic Keratosis, lung transplant, kidney transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

UCSF Dermatology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open label treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events

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

Secondary Outcome Measures

Number of Participants With a Reduction of Actinic Keratosis

To evaluate the efficacy of ingenol mebutate for reduction of actinic keratoses on the face in organ transplant recipients.

Participant's Local Skin Response Grading Scale

To investigate the local skin response to ingenol mebutate in organ transplant recipients. Local skin reaction (LSR) will be graded by visual assessment on a 4 point scale where 0=none, 1=mild, 2=moderate, 3=severe. Each of the following four reactions will be graded: erythema, vesiculation/postulation, crusting/scabbing/erosion, and edema/swelling. A composite score will be calculated (range 0-16). A high LSR indicated a worse outcome. LSR assessment will be performed at days 1, 8, 29, and 84.

Full Information

NCT ID

NCT02866695

First Posted

August 2, 2016

Last Updated

March 7, 2022

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT02866695

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

October 6, 2016 (Actual)

Primary Completion Date

July 2, 2018 (Actual)

Study Completion Date

July 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Actinic keratoses (AK) are patches of dysplastic keratinocytes arising in sun-damaged skin. These lesions are precursors to cutaneous squamous cell carcinoma (SCC), and are treated to prevent progression to SCC. First-line therapy for AK include cryotherapy and curettage, which target clinically visible lesions but do not address the subclinical lesions in the field of ultraviolet radiation damage. Field therapy includes topical chemotherapy, immunotherapy, and photodynamic therapy. Ingenol mebutate is the active compound found in Euphorbia peplus sap, and has been approved for treatment of AK in immunocompetent patients. Ingenol mebutate 0.015% is favored over other topical treatments for treatment of AK on the face due to the brief treatment course, high clearance rate, and resolution without sequelae. Solid organ transplant recipients (OTR) have a high incidence of AK and high risk of developing SCC, and require frequent field therapy. In addition, OTR generally have a higher burden of AK and require treatment of a larger surface area than the 25 cm2 area labeled for ingenol mebutate 0.015%. The investigators plan to investigate the safety and efficacy of ingenol mebutate 0.015% in OTR, with a treatment area up to 100cm2. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratosis

Keywords

Actinic Keratosis, lung transplant, kidney transplant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Open label treatment

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

ingenol mebutate gel 0.015%

Other Intervention Name(s)

Picato

Intervention Description

ingenol mebutate gel 0.015% to be applied on treatment area

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events

Description

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

Time Frame

From screening to Day 57 or study early termination if applicable

Secondary Outcome Measure Information:

Title

Number of Participants With a Reduction of Actinic Keratosis

Description

To evaluate the efficacy of ingenol mebutate for reduction of actinic keratoses on the face in organ transplant recipients.

Time Frame

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

Title

Participant's Local Skin Response Grading Scale

Description

Time Frame

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sarah Arron, MD, PhD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSF Dermatology

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data may be shared with authorized representatives of the study sponsor LEO Pharma, Inc., The University of California, FDA

Learn more about this trial

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

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