Outcomes of the A.S.A.P. Algorithm for Keloids: A Controlled Prospective Study

NCT07836569 | Completed

• 1 other identifier: 65135922.0.3001.5134
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Keloid

Keywords

Keloid; Multimodal Treatment; Cicatrix; Lasers

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Vancouver Scar Scale (VSS) Score

  The VSS evaluates four clinical scar parameters: vascularity (0-3), pigmentation (0-2), pliability (0-5), and height (0-3), yielding a total score ranging from 0 to 13. Lower scores represent clinical improvement, while higher scores indicate greater scar severity.

  Baseline and at least 6 months post-treatment initiation

Secondary Outcomes (4)

• Change from Baseline in Hamilton Scar Scale Score

  Baseline and at least 6 months post-treatment initiation

• Change from Baseline in Objective Scar Firmness

  Baseline and at least 6 months post-treatment initiation

• QualiFibro: Quality of Life Questionnaire for Patients with Fibroproliferative Scars

  Baseline and 6-18 months post-treatment initiation

• Beck Depression Inventory-II

  Baseline and at least 6 months post-treatment initiation.

Study Arms (2)

A.S.A.P. Treatment Group

EXPERIMENTAL

Patients receiving sequential treatment according to the A.S.A.P. algorithm.

Other: 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.

Interventions

A.S.A.P. Algorithm OTHER

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 minutes) and vascular technologies \[Intense Pulsed Light (IPL) 540nm (12-17 J, 15 ms) and Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) 1064nm (3 mm spot, 20 J/cm², 620-650 ms)\]. 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.

A.S.A.P. Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Concomitant medical conditions requiring systemic corticosteroids or immunosuppressive therapy
• Failure to adhere to the proposed treatment protocol

Sponsors & Collaborators

• Gisele Viana de Oliveira: lead

Study Sites (1)

Gisele Viana Dermatologia

Belo Horizonte, Minas Gerais, 30320-670, Brazil

Location

Related Publications (16)

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MeSH Terms

Conditions

Keloid; Cicatrix

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants are allocated into two concurrent groups: a treatment group and a nonrandomized control group. Patients in the treatment group undergo sequential A.S.A.P. protocol management for at least 6 months, with each treated keloid evaluated against its own baseline. Active treatment comprises hydrocolloid occlusion, low-level laser therapy, vascular-targeted technologies, and intralesional triamcinolone plus 5-fluorouracil, followed by management of residual pigmentation when indicated. Concurrently, a nonrandomized control group of untreated keloids is prospectively followed as a comparator. Outcomes in both groups are assessed at baseline and follow-up using the Vancouver Scar Scale (VSS), Hamilton Scar Scale, and objective durometer measurements. Within-patient changes are quantified, and longitudinal changes from baseline are subsequently compared between the treated and untreated groups. Also, secondary outcomes include evaluation of quality of life psychosocial indicators.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start: September 1, 2025
• Primary Completion: July 1, 2026
• Study Completion: September 10, 2026
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)