randomized clinical trial on actinic keratoses of the face

randomized clinical trial of microneedling followed by 5-Fluorouracil 5% versus use of 5-Fluorouracil 5% or 0.5% isolated in actinic keratoses of the face

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-2bqy9p

Enrollment

Unknown

Registered

2019-06-07

Start date

2016-03-31

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

actinic keratoses

Interventions

microneedling and drug delivery on face of 42 patients with actinic keratosis with 5-fluorouracil 5% or 5- fluorouracil 0.5% on a hemiface for three-days and use of 5-fluorouracil 5% or 5-fluoroura

Drug

Device

Procedure/surgery

Q65.020

Eligibility

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: patients with actinic keratosis on face with minimum age of eighteen years no history preliminary melanoma

Exclusion criteria

Exclusion criteria: renal transplanted patients in use of immunosuppressors history of previous melanoma with health change

Design outcomes

Primary

Measure	Time frame
100% remission of actinic keratosis of the face is expected to be complete with the use of microneedle reduction with the usual 15-day treatment time with 5-fluorouracil in drug delivery. besides reducing the side effects and the number of lesions	—

Secondary

Measure	Time frame
partial remission of actinic keratoses total number of lesions at the end of the study	—

Countries

Brazil

Contacts

Public ContactRenato Bakos

Universidade Federal do Rio Grande do Sul

rbakos@hcpa.edu.br+ 55-051-33598571

Outcome results

None listed

Source: REBEC (via WHO ICTRP)