Actinic Keratosis MedDRA version: 20.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Fluorouracil 5%
Product Code: Fluorouracil 5%
Pharmaceutical Form: Cream
INN or Proposed INN: FLUOROURACIL
CAS Number: 51-21-8
Other descriptive name: FLUOROURACIL
Concentration unit
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To establish the therapeutic equivalence between Fluorouracil 5% Cream, a test product from Intas Pharmaceuticals Ltd, INDIA and Efudex (Fluorouracil) 5% Cream and a product from Valeant Pharmaceuticals Ltd., USA (RLD). 2) To show superiority of test and reference products over vehicle in the treatment of multiple actinic or solar keratosis lesions in adult population. ;Secondary Objective: The secondary objective is to compare the adverse event (AE) profile of the test and the reference FU creams. ;Primary end point(s): Proportion of patients in the per protocol (PP) population with treatment success (100% clearance of all AK lesions within the treatment area) at study week 6 (4 weeks after completion of 2 weeks of treatment). ;Timepoint(s) of evaluation of this end point: Study week 6 (4 weeks after completion of 2 weeks of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of mITT population with treatment success (100% clearance of all AKs lesions within the treatment area) at week 6 (4 weeks after completion of 2 weeks of treatment) • Mean % reduction in count of AKs lesions from baseline. • Physician’s global assessment of treatment effectiveness using a scale of 1 = very effective, 2 = moderately effective, 3 = slightly effective and 4 = not effective at all. • Patient’s perception of treatment effectiveness using a scale of 1 = very effective, 2 = moderately effective, 3 = slightly effective and 4 = not effective at all. • Physician’s assessment of erythema using a scale of 0 = none, 1 = mild, 2 = moderate and 3 = severe. • Patient’s perception of discomfort associated with treatment (in terms of erythema, dryness, burning/stinging, erosion, edema, pain and itching) using a scale of 1 = very painful, 2 = moderately painful, 3 = slightly painful and 4 = not painful at all. ;Timepoint(s) of evaluation of this end point: Study week 6 (4 weeks after completion of 2 weeks of treatment) | — |
Countries
Romania, Spain
Contacts
Public ContactAlina Iordache
CEBIS International SRL
Outcome results
None listed