Evaluation of treatment of actinic keratosis with KOH5% solution in comparison to Fluorouracil 5% cream

Evaluation of clinical and dermoscopic effects of topical use of KOH 5% solution on Actinic Keratosis and its comparison with 5-Fluorouracil topical cream on patients suffering Actinic Keratosis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180909040978N1

Enrollment

Registered

2018-10-19

Start date

2018-10-22

Completion date

Unknown

Last updated

2019-01-14

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: Patients suffering Actinic Keratosis attending Razi dermatology hospital who are at least 18 years old and have a minimum number of 8 lesions (4 on each side, at le

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients suffering Actinic Keratosis attending Razi dermotology hospital Having at least 18 years of age Having a minimum number of 8 lesions( 4 on each side, at least) on parts of skin that are exposed to the sun.

Exclusion criteria

Exclusion criteria: Pregnant women People with a history of allergy to any of the drugs under study.

Design outcomes

Primary

Measure	Time frame
Smoothing of Actinic Keratosis's lesions' roughness. Timepoint: At the beginning of the study (Before the intervention begins) and 14, 28, 60 and 90 days after starting the use of KOH 5% solution and Fluorouracil cream. Method of measurement: Clinical diagnosis by dermatologist.	—

Secondary

Measure	Time frame
The improvement of dermoscopic features of Pseudo-network pattern's lesions. Timepoint: At the beginning of the study (before the intervention begins) and 14, 28, 60 and 90 days after starting the treatment using KOH 5% solution and Fluorouracil cream. Method of measurement: Analyzing the photographed dermoscopic discoveries using a FotoFinder by two dermatology professors.;The improvement of dermoscopic feature of Yellow scales' lesions. Timepoint: At the beginning of the study (before the intervention begins) and 14, 28, 60 and 90 days after starting the treatment using KOH 5% solution and Fluorouracil cream. Method of measurement: Analyzing the photographed dermoscopic discoveries using a FotoFinder by two dermatology professors.;The improvement of dermoscopic feature of White scales' lesions. Timepoint: At the beginning of the study (before the intervention begins) and 14, 28, 60 and 90 days after starting the treatment using KOH 5% solution and Fluorouracil cream. Method of measurement: Analyzing the photographed dermoscopic discoveries using a FotoFinder by two dermatology professors.;The improvement of dermoscopic feature of Linear-Wavy Vessels' lesions. Timepoint: At the beginning of the study (before the intervention begins) and 14, 28, 60 and 90 days after starting the treatment using KOH 5% solution and Fluorouracil cream. Method of measurement: Analyzing the photographed dermoscopic discoveries using a FotoFinder by two dermatology professors.;The improvement of dermoscopic feature of Pigmented Dots' lesions. Timepoint: At the beginning of the study (before the intervention begins) and 14, 28, 60 and 90 days after starting the treatment using KOH 5% solution and Fluorouracil cream. Method of measurement: Analyzing the photographed dermoscopic discoveries using a FotoFinder by two dermatology professors.	—

Measure

Time frame

The improvement of dermoscopic features of Pseudo-network pattern's lesions. Timepoint: At the beginning of the study (before the intervention begins) and 14, 28, 60 and 90 days after starting the treatment using KOH 5% solution and Fluorouracil cream. Method of measurement: Analyzing the photographed dermoscopic discoveries using a FotoFinder by two dermatology professors.;The improvement of dermoscopic feature of Yellow scales' lesions. Timepoint: At the beginning of the study (before the intervention begins) and 14, 28, 60 and 90 days after starting the treatment using KOH 5% solution and Fluorouracil cream. Method of measurement: Analyzing the photographed dermoscopic discoveries using a FotoFinder by two dermatology professors.;The improvement of dermoscopic feature of White scales' lesions. Timepoint: At the beginning of the study (before the intervention begins) and 14, 28, 60 and 90 days after starting the treatment using KOH 5% solution and Fluorouracil cream. Method of measurement: Analyzing the photographed dermoscopic discoveries using a FotoFinder by two dermatology professors.;The improvement of dermoscopic feature of Linear-Wavy Vessels' lesions. Timepoint: At the beginning of the study (before the intervention begins) and 14, 28, 60 and 90 days after starting the treatment using KOH 5% solution and Fluorouracil cream. Method of measurement: Analyzing the photographed dermoscopic discoveries using a FotoFinder by two dermatology professors.;The improvement of dermoscopic feature of Pigmented Dots' lesions. Timepoint: At the beginning of the study (before the intervention begins) and 14, 28, 60 and 90 days after starting the treatment using KOH 5% solution and Fluorouracil cream. Method of measurement: Analyzing the photographed dermoscopic discoveries using a FotoFinder by two dermatology professors.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamidreza Mahmoudi

Tehran University of Medical Sciences

hr_mahmoody@yahoo.com+98 21 5563 0174

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 17, 2026