An interventional study of A.S.A.P. Algorithm in Keloid, sponsored by Gisele Viana de Oliveira. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Gisele Viana de Oliveira · Not applicable, Interventional, and Treatment
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.
138 studies on the registry are indexed under Keloid; 26 are open to participants now.
This study's enrollment of 116 is above the median of 30 across 109 interventional studies indexed under Keloid.
Browse Keloid studies →This is the only study on the registry with Gisele Viana de Oliveira as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Sep 25, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receiving sequential treatment according to the A.S.A.P. algorithm.
Other: A.S.A.P. Algorithm
Concurrent nonrandomized control group prospectively observed and assessed at baseline and follow-up without active treatment.
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.
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.
Time frame: Baseline and at least 6 months post-treatment initiation
Change from Baseline in Hamilton Scar Scale Score
Clinical assessment of scar characteristics using the Hamilton Burn-Scar Rating Scale, 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.
Time frame: Baseline and at least 6 months post-treatment initiation
Change from Baseline in Objective Scar Firmness
Objective measurement of keloid tissue induration and hardness performed using a skin durometer.
Time frame: Baseline and at least 6 months post-treatment initiation
QualiFibro: Quality of Life Questionnaire for Patients with Fibroproliferative Scars
Minimum score: -5 Maximum score: +5 Direction: Higher scores indicate a worse outcome (greater impact of the scar on physical and psychological well-being).
Time frame: Baseline and 6-18 months post-treatment initiation
Beck Depression Inventory-II
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).
Time frame: Baseline and at least 6 months post-treatment initiation.
Plan to share: No — The datasets generated and analyzed during the current study are not publicly available due to patient privacy restrictions, but are available from the corresponding author upon reasonable request.
Ran from Sep 2025 to primary completion in Jul 2026, 10 months.
Of 20 interventional studies with no phase under Keloid, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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