Evaluation of Ingenol Mebutate for Actinic Cheilitis Treatment

NCT03452566 | Withdrawn Phase 1 DMC

• 1 other identifier: 82279418.6.0000.5274
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Actinic cheilitis is a major potentially carcinogenic disorder of the lower lip and several reports of clinical cases with excellent results for the treatment of this lesion that can differentiate to squamous cell carcinoma of the lip. However, clinical trials are lacking to define the optimal dosage of the drug for a therapeutic modality and to define its true efficacy in controlled studies of this pre-malignant labial lesion.

Conditions

Actinic Cheilitis

Keywords

actinic cheilitis; ingenol mebutate; treatment; phase 1/2 clinical trial

Outcome Measures

Primary Outcomes (1)

• Actinic cheilitis response to treatment

  A 45% partial response to ingenol mebutate

  Twelve months

Study Arms (1)

ingenol mebutate gel

EXPERIMENTAL

Phase 1/2, always 3 consecutive days, with 24 hours interval, dosage from 5 mg/cm2 to 18 mg/cm2 in a 3+3 design.

Drug: Ingenol mebutate gel

Interventions

Ingenol mebutate gel DRUG

3+3 phase 1 design as described above. After the maximum tolerated dose is defined, the phase 2 segment of the study will take place. Simon's Phase 2 study design tool was used, reinforced by Jung's admissible study designs for phase 2 clinical trials. Considering the margin of error of 0.05 and study power of 80%, and estimating the probability of placebo partial response of 15% and partial response to ingenol mebutate in 45%, the optimized number of patients to be recruited is 19. Six patients will be seen in the first stage of this segment of the study, and if only one patient or none has a partial response, the study will be promptly discontinued. Otherwise, the second and final stage of segment of the study will include an additional thirteen patients who will be treated.

Also known as: Picato

ingenol mebutate gel

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diagnosis of actinic cheilitis .
• Histopathological report compatible with the clinical diagnosis.
• Sign the informed consent to be a part of the study.
• Comply with the attendance at the clinical settings during the days the patient will be medicated (D1, D2 and D3), D5, D8, two months, six months and one year after treatment.

You may not qualify if:

• Patients younger than 18 years of age.
• Patients without confirmed diagnosis of actinic cheilitis.
• Patients previously treated with ingenol mebutate for actinic cheilitis, including those in the present study, previously excluded at some point during phases 1 or 2.
• Presence of recurrent lesions, prior or during treatment.
• Immunosuppression.
• Use of topical corticosteroids.
• Presence of markedly hyperkeratotic or ulcerated lesions in the clinical evaluation
• Patients presenting with atypical histology (moderate to severe epithelial dysplasia) at the lips.

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

MeSH Terms

Conditions

Actinic cheilitis

Interventions

3-ingenyl angelate

Study Officials

• Daniel Cohen Goldemberg, PhD

  Researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: To determine the toxicity profile and the maximum tolerated dose (MTD) of ingenol mebutate for treatment of actinic cheilitis and to determine the therapeutic response with a dose below the maximum tolerated dose (MTD). The MTD will be tested in the phase 2 stage of this study.

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 2, 2018
• Study Start: February 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: April 1, 2022
• Last Updated: June 19, 2019

Record last verified: 2019-06