The effect of two topical drugs fluorouracil 5% and niacin amide 1% in the treatment of patients with actinic keratosis

Clinical trial of Comparison of the efficacy of two topical drugs fluorouracil 5% and niacin amide 1% in the treatment of patients with actinic keratosis

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220519054920N1

Enrollment

Registered

2023-01-25

Start date

2023-01-20

Completion date

Unknown

Last updated

2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic keratosis. Actinic keratosis

Interventions

Intervention 1: Intervention group 1:In the first group, 44 lesions are entered. First, the lesions of each patient are determined precisely by examination and using dermoscopy, then the lesions are

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: New patients with actinic keratosis who have not yet received any medication Patients who have previously received topical medication and have not received topical medication in at least one month People aged 18 and over Non-hyperkeratotic lesions

Exclusion criteria

Exclusion criteria: Existence of other skin diseases at the treatment site History of hypersensitivity to fluorouracil or niacin acid Pregnant and lactating women

Design outcomes

Primary

Measure	Time frame
Improvment rate. Timepoint: Before and after intervention. Method of measurement: Scoring based on the opinion of two dermatologists.;Dermoscopic grading. Timepoint: Before and after intervention. Method of measurement: Based on scoring by two dermatologist.;Complications of treatment. Timepoint: Weeks 4 and 8 in the fluorouracil group and weeks 6 and 12 in the niacinamid group. Method of measurement: Asking the patients.	—

Measure

Time frame

Improvment rate. Timepoint: Before and after intervention. Method of measurement: Scoring based on the opinion of two dermatologists.;Dermoscopic grading. Timepoint: Before and after intervention. Method of measurement: Based on scoring by two dermatologist.;Complications of treatment. Timepoint: Weeks 4 and 8 in the fluorouracil group and weeks 6 and 12 in the niacinamid group. Method of measurement: Asking the patients.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahbube Barati

Esfahan University of Medical Sciences

mah.brti@yahoo.com+98 31 3669 5414

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026