Overview

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