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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02385318
Enrollment
519
Registered
2015-03-11
Start date
2015-02-28
Completion date
2015-12-31
Last updated
2021-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis

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.

Interventions

Sponsors

Padagis LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Provide written informed consent/assent 2. Healthy male or non-pregnant females, \>18 years old 3. Subjects must have clinical diagnosis of actinic keratosis 4. 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 5. Subjects must be willing to refrain from using non-approved products on the targeted treatment area during the study period. 6. 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. 7. Subjects must be willing and able to comply with the requirements of the study for the duration of the study period. 8. Females of childbearing potential willing to use an acceptable form of birth control Exclusion 1. Females who are pregnant, nursing, or planning a pregnancy within the study participation period 2. Subjects who are immunocompromised or HIV positive or who have any immune-system disorders including auto-immune disease 3. Subjects who have or had an active herpes infection within 14 days prior to the baseline visit 4. Subjects who have any evidence of carcinoma or any other cancer on the face and scalp 5. Presence of an incompletely healed wound within the treatment area or within 5cm of the treatment area 6. Presence of any skin condition in the treatment area that may be made worse by treatment with the study medication 7. 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 8. Subjects who plan to use artificial tanners within 5cm of the selected treatment area throughout the study 9. Use of NSAIDs within 7 days from Visit 1/Day 1 (Baseline) or initiation during the trial. 10. 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. 11. Subjects who have had or are scheduling elective surgery within 1 month before or after the study period 12. 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 13. 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. 14. 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. 15. 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. 16. Subjects who have undergone resurfacing procedures within the last 6 months prior to Visit 1/Day 1 (baseline) or planned use anytime during the study. 17. Subjects who have been treated within 1 month or planning to receive treatment with systemic retinoids, hyaluronic acid, other medicated actinic keratosis therapy, or topical steroids anywhere on the head during the study. 18. Subject who have a history of hypersensitivity or allergy to any ingredient in the drug product. 19. Use of medicated make-up in the treatment area or significant change in the use of consumer products within 30 days of Visit 1/Day 1 (baseline) and planned use or change throughout the study. 20. Start or change of dose of hormonal treatment within the past 3 months (90 days) or planned start/change throughout the study. 21. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements 22. Participation in any clinical study involving an investigational product, agent, or device in the 30 days prior to Visit 1/Day 1 (baseline) or throughout the study 23. Subjects who have been previously enrolled in this study 24. Employee of the research center or private practice 25. Subjects who in the opinion of the investigator are unlikely to be able to follow the restrictions of the protocol and complete the study

Design outcomes

Primary

MeasureTime frame
Number of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions as Determined by Visual Inspection of the InvestigatorDay 57

Participant flow

Participants by arm

ArmCount
Test Product
Ingenol Mebutate Ingenol Mebutate (Perrigo)
204
Reference Product
Ingenol Mebutate Ingenol Mebutate (Reference)
210
Placebo Product
Placebo gel Placebo gel
105
Total519

Baseline characteristics

CharacteristicTest ProductReference ProductPlacebo ProductTotal
Age, Continuous67.6 years
STANDARD_DEVIATION 9.66
67.9 years
STANDARD_DEVIATION 9.91
68.4 years
STANDARD_DEVIATION 9.67
67.9 years
STANDARD_DEVIATION 9.75
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants2 Participants5 Participants13 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
198 Participants208 Participants100 Participants506 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants2 Participants
Race (NIH/OMB)
White
203 Participants207 Participants104 Participants514 Participants
Sex: Female, Male
Female
43 Participants54 Participants18 Participants115 Participants
Sex: Female, Male
Male
161 Participants156 Participants87 Participants404 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
1 / 2040 / 2100 / 105
other
Total, other adverse events
11 / 20414 / 2100 / 105
serious
Total, serious adverse events
4 / 2041 / 2101 / 105

Outcome results

Primary

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

Time frame: Day 57

Population: Per protocol population

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Test ProductNumber of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions as Determined by Visual Inspection of the Investigator81 Participants
Reference ProductNumber of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions as Determined by Visual Inspection of the Investigator76 Participants
Placebo ProductNumber of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions as Determined by Visual Inspection of the Investigator10 Participants
90% CI: [-4.38, 14.44]Yates correction

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026