To Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis

NCT02385318 | Completed Phase 3 Results

• 1 other identifier: PRG-NY-14-019
• Study Type: interventional
• Target: 519
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of actinic keratosis.

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions as Determined by Visual Inspection of the Investigator

  Day 57

Study Arms (3)

Test Product

EXPERIMENTAL

Ingenol Mebutate

Drug: Ingenol Mebutate (Perrigo)

Reference product

ACTIVE COMPARATOR

Ingenol Mebutate

Drug: Ingenol Mebutate (Reference)

Placebo product

PLACEBO COMPARATOR

Placebo gel

Drug: Placebo gel

Interventions

Ingenol Mebutate (Perrigo) DRUG

Also known as: Perrigo product

Test Product

Ingenol Mebutate (Reference) DRUG

Also known as: Reference Listed Drug Product

Reference product

Placebo gel DRUG

Placebo product

Eligibility Criteria

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

You may qualify if:

• Provide written informed consent/assent
• Healthy male or non-pregnant females, \>18 years old
• Subjects must have clinical diagnosis of actinic keratosis
• Subjects must be in general good health and free from any clinically significant disease that might interfere with the study evaluations in the opinion of the investigator
• Subjects must be willing to refrain from using non-approved products on the targeted treatment area during the study period.
• Subjects should be willing to refrain from using any type of bandage or dressing on the treatment area or apply the gel to open skin wounds, infections, or exfoliative dermatitis.
• Subjects must be willing and able to comply with the requirements of the study for the duration of the study period.
• Females of childbearing potential willing to use an acceptable form of birth control

You may not qualify if:

• Females who are pregnant, nursing, or planning a pregnancy within the study participation period
• Subjects who are immunocompromised or HIV positive or who have any immune-system disorders including auto-immune disease
• Subjects who have or had an active herpes infection within 14 days prior to the baseline visit
• Subjects who have any evidence of carcinoma or any other cancer on the face and scalp
• Presence of an incompletely healed wound within the treatment area or within 5cm of the treatment area
• Presence of any skin condition in the treatment area that may be made worse by treatment with the study medication
• Subjects who have used a tanning salon, tanning booth, sunbathing or have excessive prolonged exposure to the sun 7 days prior to Visit 1/Day 1 (baseline) or planned throughout the study
• Subjects who plan to use artificial tanners within 5cm of the selected treatment area throughout the study
• Use of NSAIDs within 7 days from Visit 1/Day 1 (Baseline) or initiation during the trial.
• Subjects who had select cosmetic or therapeutic procedures within 2cm of the selected treatment area and within 14 days of Visit 1/Day 1 (baseline) or within 10cm of the selected treatment area planned anytime during the study.
• Subjects who have had or are scheduling elective surgery within 1 month before or after the study period
• Prior use within 30 days of Visit 1/ Day 1 (baseline) or planned use during the study of immunomodulators, immunosuppressive therapies, interferon, interferon inducers, systemic corticosteroids, and cytotoxic drugs
• Subjects undergoing treatment or received treatment within 8 weeks of Visit 1/Day 1 (baseline) and within 2cm of the selected area or planned during anytime in the study of: 5-FU, imiquimod, diclofenac, photodynamic therapy used in combination with photosensitizing cream.
• Subjects who used PUVA or UVB therapy on the face or scalp within 6 months prior to Visit 1/Day 1 (baseline) or are planning to receive PUVA therapy, UVB therapy, or nonprescription UV light sources anywhere on the body during the study.
• Subjects who have taken systemic chemotherapy medications within the last 6 months prior to Visit 1/Day 1 (baseline) or planned use anytime during the study.

Sponsors & Collaborators

• Padagis LLC: lead

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: Jonathan Schwartz
• Organization: Perrigo

jonathan.schwartz@perrigo.com

718-960-9900

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2015
• First Posted: March 11, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 2, 2021
• Results First Posted: January 22, 2021

Record last verified: 2021-10