Therapeutic Equivalence of Fluorouracil Cream, 5% Compared With Fluorouracil 5% Topical Cream of MylanPharmaceuticals Inc., U.S.A in the Treatment of Actinic Keratosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Actinic Keratoses

In brief

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.

Key facts

Study ID

NCT05078827

Run by

Encube Ethicals Pvt. Ltd.

People needed

458

Starts

2022-03-01

Expected to finish

2022-12-01

Last updated by the study team

2023-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• CBCC Global Research Site 005 — Bakersfield, California, United States
• CBCC Global Research Site 006 — Cerritos, California, United States
• CBCC Global Research Site 004 — Lauderdale Lakes, Florida, United States
• CBCC Global Research Site 001 — Miami, Florida, United States
• CBCC Global Research Site 002 — Miami, Florida, United States
• CBCC Global Research Site 003 — Miramar, Florida, United States
• CBCC Global Research Site 007 — Sugarloaf, Pennsylvania, United States

Full record on ClinicalTrials.gov

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