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

NCT02459795 | Completed Phase 3 Results

• 1 other identifier: PRG-NY-15-002
• Study Type: interventional
• Target: 469
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare safety and efficacy of Perrigo's drug compared to an FDA approved drug 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

  Baseline to Day 57

Study Arms (3)

Test product

EXPERIMENTAL

Ingenol Mebutate (Perrigo)

Drug: Ingenol Mebutate (Perrigo)

Reference product

ACTIVE COMPARATOR

Ingenol Mebutate (Reference)

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

Also known as: placebo

Placebo product

Eligibility Criteria

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

You may qualify if:

• IRB approved written informed consent/assent for this study.
• Healthy males or females, at least 18 years of age.
• General good health and free from any clinically significant disease, other than Actinic Keratosis
• Clinical diagnosis of Actinic Keratosis, defined as having 4 to 8 clinically typical, visible and discrete, non-hyperkeratotic, non-hypertrophic, Actinic Keratosis lesions within a contiguous 25cm2 treatment area.
• Willing to refrain from using lotions, sunscreens, moisturizers, cleansers, or creams on the treatment area during the treatment period. Non-Medicated moisturizers, emollients, humectants, sunscreens or similar products used routinely prior to the start of the trial by subjects, may be used after the treatment period.
• Willing to refrain from using any type of bandage or occlusive dressing on the treatment area or applying the gel to open skin wounds, infections or exfoliative dermatitis.
• Willing and able to understand and comply with the requirements of the study, apply the study medication as instructed, refrain from use of all other topical Actinic Keratosis medication during the 57 day (8 week) study period, return for the required study visits, comply with therapy prohibitions, and are able to complete the study.
• Females of childbearing potential (excluding women who are surgically sterilized or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day 1 (Baseline), must be willing to use an acceptable form of birth control during the study.

You may not qualify if:

• Pregnant, nursing, or planning a pregnancy within the study period.
• Immunocompromised or HIV positive or who have any immune-system disorders including auto-immune diseases.
• Active herpes infection within 14 days prior to the Visit1/Day 1 (Baseline) (i.e., including presence of herpes labialis).
• Any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, or any other cancer in the treatment area.
• Presence of an incompletely healed wound within the treatment area or within 5 cm of the treatment area.
• Presence of any confounding skin conditions in the treatment area that may be made worse by treatment with Ingenol Mebutate gel (e.g., psoriasis, atopic dermatitis, eczema).
• Subjects who have used a tanning salon and/or tanning booths or have sunbathed or had 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 5 cm of the selected treatment area throughout the study.
• Use of NSAIDs within 7 days from Visit 1/Day 1 (Baseline) or initiation during the study. \*Subjects may use Tylenol (Acetaminophen) for pain relief, as needed, throughout the study. Subjects may use low dose aspirin (81mg) for cardiac prophylaxis throughout the study.
• Subjects who had cosmetic or therapeutic procedures such as the following within 2 cm of the selected treatment area within 2 weeks (14 days) of Visit 1/Day 1 (Baseline) and within 10 cm of the selected treatment area planned anytime during the study.
• Cryodestruction/ cryotherapy/liquid nitrogen
• Surgical excision
• Curettage
• Dermabrasion
• Medium or greater depth chemical peel

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: May 29, 2015
• First Posted: June 2, 2015
• Study Start: May 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