Clinical and Objective Outcomes of the A.S.A.P. Algorithm for Keloids: A Prospective Longitudinal Within-Patient Study With an Untreated Comparison Group
| Registry | NCT07836569 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, treatment |
| Enrollment | 116 (Actual) |
| Sponsor | Gisele Viana de Oliveira (Other) |
| Conditions | Keloid |
| Interventions | A.S.A.P. Algorithm (Other) |
| Dates | start 2025-09-01, primary completion 2026-07-01, completion 2026-09-10, first posted 2026-09-23, last updated 2026-09-29 |
| Locations | 1 site in Brazil |
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All trials for Keloid All trials of A.S.A.P. Algorithm
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 (LLLT), 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.
Keloid management remains challenging due to clinical heterogeneity, variable treatment responses, and limited objective evidence supporting multimodal treatment strategies. The A.S.A.P. algorithm is a structured, sequential, predominantly nonsurgical protocol incorporating Assessment, Softening, Approach, and Pigmentation management.
This prospective, longitudinal, quasi-experimental study aims to evaluate within-patient changes in clinical and objective keloid outcomes following treatment with the A.S.A.P. algorithm over a minimum 6-month period, while comparing these changes against a concurrent nonrandomized group of untreated keloids.
Study Workflow:
Assessment (A): Initial clinical evaluation, symptom assessment, and classification of keloid lesions.
Softening (S): Application of hydrocolloid occlusion, silicone dressings, or pressure garments for 2-12 months to reduce tissue firmness, alleviate symptoms, and prepare the lesion for injections.
Approach (A): Utilization of vascular-targeted technologies (such as Intense Pulsed Light - IPL) followed by monthly intralesional injections combining triamcinolone hexacetonide (TH) with 5-fluorouracil (5-FU) or bleomycin.
Pigmentation \& Quality (P): Management of residual hyperpigmentation or hypopigmentation and skin texture using topical therapies (hydroquinone, glycolic acid, 8-methoxypsoralen \[8-MOP\]), chemical peels, microneedling, or fractional lasers.
Outcome Measurements:
Lesion changes are evaluated at baseline and at follow-up intervals using the Vancouver Scar Scale (VSS), Hamilton Scar Scale, and objective durometer measurements to quantify skin firmness and elasticity.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| A.S.A.P. Treatment Group | Experimental | Other: A.S.A.P. Algorithm | Patients receiving sequential treatment according to the A.S.A.P. algorithm. |
| Untreated Control Group | No intervention | Concurrent nonrandomized control group prospectively observed and assessed at baseline and follow-up without active treatment. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Male or female patients aged 18 years or older * Clinical diagnosis of keloid established by an experienced senior dermatologist * No treatment received for keloid for at least 12 months prior to study enrollment * Willingness to participate in the study, documented by written informed consent Exclusion Criteria: * Concomitant medical conditions requiring systemic corticosteroids or immunosuppressive therapy * Failure to adhere to the proposed treatment protocol
| Facility | City | Country | Status |
|---|---|---|---|
| Gisele Viana Dermatologia | Belo Horizonte, Minas Gerais | Brazil |