Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
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.
Subjects who have had or are scheduling elective surgery within 1 month (30 days) before or after the study period.
Use within 1 month (30 days) prior to Visit 1/Day 1 (Baseline) or planned use during the study of:
Subjects who are undergoing treatment or received treatment with the following within 2 months (56 days) of Visit 1/Day 1 (Baseline) and within 2 cm of the selected treatment area or planned anytime during the study.
Use of Ingenol Mebutate gel within 2 months (56 days) of Visit 1/Day 1. Previous use (if > 2 months (56 days) of Ingenol Mebutate gel is allowed if a different treatment area was successfully treated.)
History of unresponsiveness, hypersensitivity or allergy to ingenol mebutate therapy and/or any ingredient in the study medication.
Subjects who used PUVA (psoralen plus ultraviolet A therapy), or UVB therapy in the treatment area within 6 months (180 days) prior to Visit 1/Day 1 (Baseline) or are planning to receive treatment with PUVA therapy, UVB therapy, nonprescription UV light sources anywhere on the body during the study.
Subjects who have taken systemic chemotherapy medications within 6 months (180 days) prior to Visit 1/Day 1 (Baseline) or planned use anytime during the study.
Subjects who have undergone Botox procedures in the selected treatment area 6 months (180 Days) prior to Visit 1/Day 1 (Baseline).
Subjects who have been treated within 1 month (30 days) or are planning to receive treatment with 1) systemic retinoids (i.e., oral isotretinoin, acitretin, bexarotene), 2) hyaluronic acid, 3) other medicated Actinic Keratosis therapy (i.e., prescription topical retinoids, topical salicyclic acid, bichloroacettic acid, trichloroacetic aid, CO2 laser vaporization, electrocautery), 4) topical steroids (use within 2 cm of the selected treatment area after study Day 15 per PI discretion is allowed) anywhere on the treatment area during the study.
Subjects who have had a 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. ("Significant change" will be determined by the Principal Investigator)
Start or change of dose of hormonal treatment (oral, implanted, topical contraceptives and androgens) within the past 3 months (90 days) or planned start or change throughout the study. Use of such therapy must remain constant during the study.
Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.
Participation in any clinical study involving an investigational product, agent or device (that might influence the intended effects or mask the side effects of study medication) in the 30 days prior to Visit 1/Day 1 (Baseline) or throughout the study.
Previous enrollment in this study or current enrollment in this study at another participating site.
Employee (or employee's family member) of the research center or private practice, or subjects who have a conflict of interest.
Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study
Primary purpose
Allocation
Interventional model
Masking
469 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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