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Study about the treatment of pre-cancer skin lesions

Study on 70% glycolic acid peeling associated with 5-fluorouracil 5% compared to the topical use of 5-fluorouracil 5% cream in the treatment of actinic keratosIs: a non-randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-78mj2c
Enrollment
Unknown
Registered
2018-11-26
Start date
2017-04-28
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 keratosis

Interventions

Randomized clinical trial with 44 upper limbs (in 17 patients), 17 upper limbs were randomized to topical treatment with 70% glycolic acid peeling gel combined with 5-fluorouracil 5% peel in solution
Drug
Procedure/surgery
D03.383.742.698.875.404
E02.218.170
E02.547.800.500

Sponsors

Universidade de Cruz Alta
Lead Sponsor
Universidade Regional do Noroeste do Estado do Rio Grande do Sul - UNIJUI
Collaborator

Eligibility

Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Over 18 years of age; clinical diagnosis of multiple actinic keratoses in the upper limbs (hands and forearms); minimum of five actinic keratoses in each upper limb; signed by the Free and Informed Consent Form.

Exclusion criteria

Exclusion criteria: Decompensated systemic diseases; previous treatment of actinic keratosis in the three months prior to the beginning of the study; use of topical steroids in the four weeks prior to the study; clinical suspicion of skin cancer in the upper limbs; Known hypersensitivity to 5-fluorouracil; defects in inherited or acquired coagulation.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: reduction of the mean number of actinic keratoses treated in the upper limbs with peeling or 5-fluorouracil 5% cream. Counting performed manually, pre-intervention and after 15 days of the last intervention.;Expected outcome 2: reduction of measures of actinic keratoses treated in the upper limbs with peeling or 5-fluorouracil 5% cream. The measurement of each of the demarcated lesions was performed with a transparent 15 cm ruler and was considered its largest diameter in centimeters before intervention and after 15 days of the last intervention.—

Secondary

MeasureTime frame
Adverse effects observed in the presence of erythema, edema, pain, pruritus, vesiculation and crusts measured after 15 days of the end of treatment—

Countries

Brazil

Contacts

Public ContactCristiane ;Eliane Heuser ;Winkelmann

Universidade Regional do Noroeste do Estado do Rio Grande do Sul - UNIJUI;Universidade Regional do Noroeste do Estado do Rio Grande do Sul - UNIJUI

crisludtke85@hotmail.com;elianew@unijui.edu.br55(55)33331247;+55-55-999224402

Outcome results

None listed

Source: REBEC (via WHO ICTRP)