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Clinical and Objective Outcomes of the A.S.A.P. Algorithm for Keloids: A Prospective Longitudinal Within-Patient Study With an Untreated Comparison Group
Sponsor: Gisele Viana de Oliveira
Summary
The goal of this clinical trial is to evaluate if the A.S.A.P. algorithm can treat and improve clinical and objective outcomes in patients with keloids. The main questions it aims to answer are: Does sequential treatment with the A.S.A.P. algorithm significantly improve keloid scar characteristics and firmness compared to baseline? Are the longitudinal clinical and objective improvements greater in keloids treated with the A.S.A.P. algorithm compared to an untreated control group? Researchers will compare keloids treated with the sequential A.S.A.P. algorithm to a concurrent untreated group of keloids to see if the treatment algorithm produces superior improvements in scar severity and firmness. Participants will: Undergo sequential treatment according to the A.S.A.P. algorithm for at least 6 months, which includes hydrocolloid occlusion, low-level laser therapy, vascular-targeted technologies, intralesional triamcinolone plus 5-fluorouracil, and treatment of residual pigmentation. Complete clinical scar evaluations at baseline and follow-up using the Vancouver Scar Scale (VSS) and Hamilton Scar Scale. Undergo objective scar firmness measurements at baseline and follow-up using a durometer. If in the nonrandomized control group, be prospectively observed and assessed at baseline and follow-up without receiving active treatment.
Official title: RETROSPECTIVE AND PROSPECTIVE STUDY OF KELOIDS AND REVIEW OF TREATED CASES/ESTUDO RETROSPECTIVO E PROSPECTIVO DE QUELOIDE E REVISÃO DE CASOS ATENDIDOS
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2025-09-01
Completion Date
2026-09-10
Last Updated
2026-09-23
Healthy Volunteers
No
Conditions
Interventions
A.S.A.P. Algorithm
A - Assessment: Baseline clinical evaluation including standardized photo documentation, phototype assessment, and skin durometer measurements. S - Soften: Continuous occlusive hydrocolloid dressings (DuoDERM) secured with Micropore, changed biweekly in-clinic or self-managed with monthly evaluations. A - Approach: Monthly sessions of low-level laser therapy (7 min) and vascular technologies \[IPL 540nm (12-17 J, 15 ms) and Nd:YAG 1064nm (3 mm spot, 20 J/cm², 620-650 ms)\]. Followed immediately by intralesional injection of triamcinolone plus 5-fluorouracil (1:9 ratio; 0.2 mL per 1.5 cm², max 1.5 mL/session) and re-application of occlusive dressings. P - Pigmentation: After lesion flattening, pigmentary alterations are treated using light and laser devices (IPL 640nm, picosecond laser), retinoic acid peels, and topical depigmenting agents.
Locations (1)
Gisele Viana Dermatologia
Belo Horizonte, Minas Gerais, Brazil