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Completed

NCT Number: NCT07836569

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gisele Viana Dermatologia

Belo Horizonte, Minas Gerais, 30320-670, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change from Baseline in Vancouver Scar Scale (VSS) Score

    Time frame: Baseline and at least 6 months post-treatment initiation

    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.

Secondary outcomes

  1. Change from Baseline in Hamilton Scar Scale Score

    Time frame: Baseline and at least 6 months post-treatment initiation

    Clinical assessment of scar characteristics using the Hamilton Burn-Scar Rating Scale (from Crowe JM, Simpson K, Johnson W, Allen J. Reliability of photographic analysis in determining change in scar appearance. J Burn Care Rehabil. 1998 Mar-Apr;19(2):183-6. doi: 10.1097/00004630-199803000-00019. PubMed ID: 9556325), evaluating thickness (0-3), irregularity (0-4), vascularity (0-4), and pigmentation (0-3). Total score ranges from 0 to 14, where 0 represents normal skin and 14 represents maximum scar severity. Higher scores indicate worse outcome.

  2. Change from Baseline in Objective Scar Firmness

    Time frame: Baseline and at least 6 months post-treatment initiation

    Objective measurement of keloid tissue induration and hardness performed using a skin durometer.

  3. QualiFibro: Quality of Life Questionnaire for Patients with Fibroproliferative Scars

    Time frame: Baseline and 6-18 months post-treatment initiation

    Minimum score: -5 Maximum score: +5 Direction: Higher scores indicate a worse outcome (greater impact of the scar on physical and psychological well-being).

  4. Beck Depression Inventory-II

    Time frame: Baseline and at least 6 months post-treatment initiation.

    Minimum score: 0

    Maximum score: 63

    Scale: 21 items, each scored from 0 to 3.

    These values refer to the BDI-II (Beck Depression Inventory-II).

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Sponsors and collaborators

Lead sponsor

Gisele Viana de Oliveira

Other

Registry information

Official study title

Clinical and Objective Outcomes of the A.S.A.P. Algorithm for Keloids: A Prospective Longitudinal Within-Patient Study With an Untreated Comparison Group

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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