A study to evaluate if a new cream of Fluorouracil 5% for treatment of actinic keratoses lesions is equivalent to an existing one that also contains Fluorouracil 5%

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

1. Males and females of any ethnic group, over 18 years of age at the time of signing the informed consent.
2. Patients with Fitzpatrick skin type I, II and III
3. Patients with at least 5 but no more than 10 clinically typical, visible, discrete actinic keratoses (AKs) lesions on the face or bald scalp with each lesion measuring at least 4 mm in diameter.
4. Both male and female patients of child bearing potential must be practicing adequate contraception and female patients of child-bearing potential must not be pregnant or
lactating and must have a negative serum pregnancy test at screening and negative urine pregnancy test at randomization.
5. Patient is capable of understanding the purposes and risks of the trial, is able to comply with the study requirements and restrictions as listed in the consent form and has given
written informed consent
6. Patient has not taken and agrees not to take any medication or therapy prohibited by the protocol for the entire study period
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. Presence of atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, albinism or other confounding skin conditions on the face or bald scalp.
2. Patients with lesions that are hyperkeratotic, thicker than 1 mm (a piece of paper) or larger than 9mm or suspicious for squamous cell carcinoma.
3. Use within six months prior to screening on the face or bald scalp of 1) chemical peel, 2) dermabrasion, 3) laser abrasion, 4) PUVA (Psoralen plus UltraViolet A) therapy, or 5) UVB therapy.
4. Use within one month prior to screening on the face or scalp of 1) cryodestruction or chemodestruction, 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 actinic keratoses.
5. Use within one month prior to screening of 1) immunomodulators or immunosuppressive therapies, 2) interferon, 3) oral corticosteroids 4) cytotoxic drugs or 5) medicines like
brivudine, sorivudine, etc. to treat chickenpox or shingles.
6. Known allergies to fluorouracil or any excipients in the test product or the RLD.
7. The total area of skin with AK needing treatment at a time exceeding 500cm^2 (approx. 23 x 23 cm) or (9 x 9 inches), the size of a dinner plate.
8. Known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.
9. Any dermatological condition such as scar/wound/tattoo at the application site or in its close vicinity that in the Investigator's opinion may interfere with the evaluation of the
patient's AKs.
10. Known case of HIV infection.
11. A positive hepatitis screen including hepatitis B surface antigen, HCV, HAV and IgM antibodies.
12. Clinical evidence of severe, uncontrolled auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, pulmonary or renal disease.
13. Serious psychological illness.
14. Significant history (within the past 1 year) of alcohol or drug abuse (unable to control its consumption despite negative consequences).
15. Participation in any clinical research study during the 30 day period preceding the current study screening or 5 half-lives of the last intake of the IMP during the previous study
whichever is later.
16. Medical history which, based on the clinical judgment of the investigator, implies a likelihood of unsuccessful completion of the study.
17. Use of sun lamps or sun tanning beds or booths from 1 week prior to screening until End of Study (EoS) visit on Day 42.
18. Scheduled elective surgery within 30 days of study.
19. Not willing to visit the site without make up on face or neck.
20. Patients engaged in occupation requiring prolonged exposure to sunlight/non-ionizing UV radiation.
21. Prior treatment with systemic 5-fluorouracil or intended systemic cancer therapy within 6 months of study entry

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials