Therapeutic Equivalence of Fluorouracil Cream, 5% Compared With EFUDEX® in the Treatment of Actinic Keratosis

• Status: Not yet recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

Summary

Fluorouracil is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Encube Ethicals Pvt. Ltd.
• Collaborator: CBCC Global Research
• Treatments: Fluorouracil

Criteria

Inclusion Criteria:

• Willing and able to provide voluntary informed consent and follow the protocol requirements

• Males or females at least 18 years of age

• Subjects with at least five (5) and no more than ten (10) clinically typical, visible, discrete, AK lesions, each at least 4 mm in diameter on the face or bald scalp. In this interpretation, if the total number of lesions on the face and bald scalp exceeds 10 and there are either 5-10 lesions on the face or 5-10 lesions on the bald scalp then select the designated treatment area that has 5-10 lesions (i.e., face or bald scalp)

• Skin pigmentation (Fitzpatrick skin type I, II, and III) that will allow differentiation of erythema assessment

• Females of childbearing potential must not be pregnant or lactating at Visit 1 (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 mIU/mL or equivalent units of human chorionic gonadotropin)

• Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, intrauterine device, a double barrier method, oral, transdermal, injected, or implanted nonhormonal or hormonal contraceptive) throughout the study. Female patients using hormonal contraceptives should have been on the same product/dosing regimen for at least 28 days before Visit 1 and should not change this regimen during the study. A sterile sexual partner is not considered an adequate form of birth control.

Exclusion Criteria:

• Known hypersensitivity or allergy to Fluorouracil or any of the excipients in the Test, Reference or Placebo products

• Presence of atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, or other possible confounding skin conditions on the face or bald scalp

• Use within 6 months before Visit 1 on the face or bald scalp of 1) chemical peel, 2) dermabrasion, 3) laser abrasion, 4) PUVA (psoralen plus ultraviolet A) therapy, or 5) ultraviolet B therapy

• Use within 1 month before Visit 1 on the face or scalp of 1) cryo destruction or chemo destruction, 2) curettage, 3) photodynamic therapy, 4) surgical excision, 5) topical 5-fluorouracil, 6) topical corticosteroids 7) topical diclofenac, 8) topical imiquimod, 9) topical retinoids, or 10) other treatments for AK including glycolic acid or over-the-counter products containing retinol, alpha or beta hydroxy acids

• Use within 1 month before Visit 1 of 1) immunomodulators or immunosuppressive therapies, 2) interferon, 3) oral or injectable corticosteroids, or 4) cytotoxic drugs

• Known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency

• Inability to understand the requirements of the study and the relative information or are unable or not willing to comply with the study protocol

• Employees of the Investigator or research center or their immediate family members

• Patients who have participated in this study previously

• Patient lived in the same household as currently enrolled subject