NCT02866695

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

Completed Phase 4 Results posted Last updated 9 March 2022

What this trial tests

Phase 4 trial testing ingenol mebutate gel 0.015% in Actinic Keratosis in 20 participants. Completed in 2 July 2018.

Timeline

6 October 2016

Primary endpoint
2 July 2018

2 July 2018

Quick facts

Lead sponsor	University of California, San Francisco
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	6 October 2016
Primary completion	2 July 2018
Estimated completion	2 July 2018
Sites	1 location across United States

Drugs / interventions tested

• ingenol mebutate gel 0.015%

Conditions studied

• Actinic Keratosis — all drugs for Actinic Keratosis →

Sponsor

University of California, San Francisco

Who can join

18 and older, any sex, with Actinic Keratosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events Primary · From screening to Day 57 or study early termination if applicable

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

Facial edema

Group	Value	95% CI
Open Label Treatment	12

Pain in Treatment Area

Group	Value	95% CI
Open Label Treatment	11

Pruritus

Group	Value	95% CI
Open Label Treatment	6

Headache

Group	Value	95% CI
Open Label Treatment	3

Squamous Cell Carcinoma Outside Treatment Area

Group	Value	95% CI
Open Label Treatment	3

Diarrhea

Group	Value	95% CI
Open Label Treatment	2

Xerosis

Group	Value	95% CI
Open Label Treatment	2

Urosepsis

Group	Value	95% CI
Open Label Treatment	1

Number of Participants With a Reduction of Actinic Keratosis Secondary · Day 57 (assessed at screening, day 1, day 29, day 57, and study early termination if applicable, clearance at day 57 reported)

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

75% Clearance of Actinic Keratoses at Day 57

Group	Value	95% CI
Open Label Treatment	12

100% Clearance of Actinic Keratoses at Day 57

Group	Value	95% CI
Open Label Treatment	8

Participant's Local Skin Response Grading Scale Secondary · 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)

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.

Baseline Local Skin Reaction Composite Score

Group	Value	95% CI
Open Label Treatment	1.2	± 0.8

Day 4 Local Skin Reaction Composite Score

Group	Value	95% CI
Open Label Treatment	11.7	± 4.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Each participant was assessed for 57 days from the start of treatment.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Open Label Treatment

Serious: 5/20 (25%)

Deaths: 0/20

Serious adverse events (5 terms)

Reaction	System	Open Label Treatment
Urosepsis	Renal and urinary disorders	—
Diarrhea	Gastrointestinal disorders	—
Chronic Kidney Disease	Renal and urinary disorders	—
Anemia	Blood and lymphatic system disorders	—
Hypertriglyceridemia	Metabolism and nutrition disorders	—

Other adverse events (7 terms — click to expand)

Reaction	System	Open Label Treatment
Acute Kidney Injury	Renal and urinary disorders	—
Hyperglycemia	Metabolism and nutrition disorders	—
Hyponatremia	Renal and urinary disorders	—
Hypoalbuminemia	Renal and urinary disorders	—
Hyperkalemia	Renal and urinary disorders	—
Hypocalcemia	Renal and urinary disorders	—
Neutropenia	Blood and lymphatic system disorders	—

Most-reported serious reactions: Urosepsis, Diarrhea, Chronic Kidney Disease, Anemia, Hypertriglyceridemia.

Data from ClinicalTrials.gov NCT02866695 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.