KeloidNCT07836569

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

A study testing A.S.A.P. Algorithm in people with Keloid, run by Gisele Viana de Oliveira at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Keloid
What is being tested?: A.S.A.P. Algorithm
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 116 participants
Where: 1 siteBrazil
Study dates: 1 Sep 2025to 10 Sep 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Gisele Viana Dermatologia
Belo Horizonte, Minas Gerais, 30320-670

Other trials in Brazil

About this study

Official 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

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.

Read the detailed description

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.

Conditions: Keloid
Being tested: A.S.A.P. Algorithm
Keywords: Keloid, Multimodal Treatment, Cicatrix, Lasers
Medical subject headings: Keloid, Cicatrix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

A.S.A.P. AlgorithmOther
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.

Study groups in NCT07836569
Study group	Role	What they receive
A.S.A.P. Treatment Group	Experimental	Patients receiving sequential treatment according to the A.S.A.P. algorithm. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Baseline and at least 6 months post-treatment initiation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202510 Sep 2026

First posted23 Sep 2026
Study start1 Sep 2025
Primary completion1 Jul 2026
Study completion10 Sep 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for KeloidStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07836569
Sponsor's protocol ID: 65135922.0.3001.5134
Status last verified: Sep 2026
First submitted: 17 Sep 2026
Last updated: 29 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Publications

Conte S, Kamali K, Muncey-Buckley M, Abbas K, Sabljic T, Mukovozov IM. Complications of Body Piercings: A Systematic Review. Cutis. 2023 Sep;112(3):139-145. doi: 10.12788/cutis.0847.
PubMed 37903388
Murray JC, Pollack SV, Pinnell SR. Keloids: a review. J Am Acad Dermatol. 1981 Apr;4(4):461-70. doi: 10.1016/s0190-9622(81)70048-3.
PubMed 7014664
Ogawa R. Keloid and Hypertrophic Scars Are the Result of Chronic Inflammation in the Reticular Dermis. Int J Mol Sci. 2017 Mar 10;18(3):606. doi: 10.3390/ijms18030606.
PubMed 28287424
Kim HJ, Kim YH. Comprehensive Insights into Keloid Pathogenesis and Advanced Therapeutic Strategies. Int J Mol Sci. 2024 Aug 12;25(16):8776. doi: 10.3390/ijms25168776.
PubMed 39201463
Valle LNDC, Mendes VB, Melchiors Stahlschmidt AP, Andrade FR, Silva MR, de Oliveira GV. Body appreciation and psychosocial indicators in patients with keloids, hypertrophic scars, and burn scars. Scars Burn Heal. 2026 Jul 24;12:20595131261468100. doi: 10.1177/20595131261468100. eCollection 2026 Jan-Dec.
PubMed 42502838
Falanga V, Bucalo B. Use of a durometer to assess skin hardness. J Am Acad Dermatol. 1993 Jul;29(1):47-51. doi: 10.1016/0190-9622(93)70150-r.
PubMed 8315077
Shaheen A, Khaddam J, Kesh F. Risk factors of keloids in Syrians. BMC Dermatol. 2016 Sep 20;16(1):13. doi: 10.1186/s12895-016-0050-5.
PubMed 27646558
Brandao MPAS, Vieira CFO, Rocha DBB, Silva MR, da Silva JA, Gold MH, de Oliveira GV. Outcomes of a Non-Surgical Combination Therapy for Keloids in Skin of Color Patients: A 10-Year Follow-Up Study. Int J Dermatol. 2025 Aug;64(8):1434-1440. doi: 10.1111/ijd.17829. Epub 2025 May 5.
PubMed 40322860
de Oliveira GV, Nunes TA, Magna LA, Cintra ML, Kitten GT, Zarpellon S, Raposo Do Amaral CM. Silicone versus nonsilicone gel dressings: a controlled trial. Dermatol Surg. 2001 Aug;27(8):721-6. doi: 10.1046/j.1524-4725.2001.00345.x.
PubMed 11493295
Oliveira GV, Chinkes D, Mitchell C, Oliveras G, Hawkins HK, Herndon DN. Objective assessment of burn scar vascularity, erythema, pliability, thickness, and planimetry. Dermatol Surg. 2005 Jan;31(1):48-58. doi: 10.1111/j.1524-4725.2005.31004.
PubMed 15720096
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 9556325
Sullivan T, Smith J, Kermode J, McIver E, Courtemanche DJ. Rating the burn scar. J Burn Care Rehabil. 1990 May-Jun;11(3):256-60. doi: 10.1097/00004630-199005000-00014.
PubMed 2373734
van Zuijlen PP, Angeles AP, Kreis RW, Bos KE, Middelkoop E. Scar assessment tools: implications for current research. Plast Reconstr Surg. 2002 Mar;109(3):1108-22. doi: 10.1097/00006534-200203000-00052.
PubMed 11884845
de Oliveira GV, Metsavaht LD, Kroumpouzos G. ASAP revisited: The Brazilian sequential algorithm for treating keloids and hypertrophic scars. Clin Dermatol. 2026 Jan-Feb;44(1):192-196. doi: 10.1016/j.clindermatol.2025.10.011. Epub 2025 Oct 29.
PubMed 41173162
Viana de Oliveira G, Druck PA, Acevedo AAL, Hexsel D, Gontijo GT, Rivera GH, Velazquez-Arenas LL, Addor FASA, Zaputovich FA, Leal-Silva H, Leal-Delgado S, Escribens CE, Murillo KDO, Misticone S, D'orsi Metsavaht L, de la Riva J, Galimberti DR, Jedwab SKK, Garcia HRG, Silva MRE, Andrade MR, Reis-Filho E, Silva MR, Krompouzos G, Guzman-Sanchez D. Consensus on energy-based devices for keloids and hypertrophic scars: A Latin American Delphi study. J Eur Acad Dermatol Venereol. 2026 Aug 10. doi: 10.1111/jdv.70636. Online ahead of print.
PubMed 42573498

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Keloid trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT07836569
Acronym / sponsor ID: 65135922.0.3001.5134
Conditions: Keloid
Keywords: Keloid, Multimodal Treatment, Cicatrix, Lasers
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: Gisele Viana de OliveiraUniversity, hospital or other
Study start: 1 Sep 2025 (actual)
Primary completion: 1 Jul 2026 (actual)
Study completion: 10 Sep 2026 (actual)
First posted: 23 Sep 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

Participants will:

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.

Detailed description

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.

Outcome Measurements:

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
A.S.A.P. Treatment Group	Experimental	Other: A.S.A.P. AlgorithmPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
A.S.A.P. AlgorithmA - 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.	Other	A.S.A.P. Treatment Group

Primary outcome

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.

4 secondary outcomes

Change from Baseline in Hamilton Scar Scale Score
Time frame: Baseline and at least 6 months post-treatment initiation
Change from Baseline in Objective Scar Firmness
Time frame: Baseline and at least 6 months post-treatment initiation
QualiFibro: Quality of Life Questionnaire for Patients with Fibroproliferative Scars
Time frame: Baseline and 6-18 months post-treatment initiation
Beck Depression Inventory-II
Time frame: Baseline and at least 6 months post-treatment initiation.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
Background: PubMed 37903388Conte S, Kamali K, Muncey-Buckley M, Abbas K, Sabljic T, Mukovozov IM. Complications of Body Piercings: A Systematic Review. Cutis. 2023 Sep;112(3):139-145. doi: 10.12788/cutis.0847.
Background: PubMed 7014664Murray JC, Pollack SV, Pinnell SR. Keloids: a review. J Am Acad Dermatol. 1981 Apr;4(4):461-70. doi: 10.1016/s0190-9622(81)70048-3.
Background: PubMed 28287424Ogawa R. Keloid and Hypertrophic Scars Are the Result of Chronic Inflammation in the Reticular Dermis. Int J Mol Sci. 2017 Mar 10;18(3):606. doi: 10.3390/ijms18030606.
Background: PubMed 39201463Kim HJ, Kim YH. Comprehensive Insights into Keloid Pathogenesis and Advanced Therapeutic Strategies. Int J Mol Sci. 2024 Aug 12;25(16):8776. doi: 10.3390/ijms25168776.
Background: PubMed 42502838Valle LNDC, Mendes VB, Melchiors Stahlschmidt AP, Andrade FR, Silva MR, de Oliveira GV. Body appreciation and psychosocial indicators in patients with keloids, hypertrophic scars, and burn scars. Scars Burn Heal. 2026 Jul 24;12:20595131261468100. doi: 10.1177/20595131261468100. eCollection 2026 Jan-Dec.
Background: PubMed 8315077Falanga V, Bucalo B. Use of a durometer to assess skin hardness. J Am Acad Dermatol. 1993 Jul;29(1):47-51. doi: 10.1016/0190-9622(93)70150-r.
Background: PubMed 27646558Shaheen A, Khaddam J, Kesh F. Risk factors of keloids in Syrians. BMC Dermatol. 2016 Sep 20;16(1):13. doi: 10.1186/s12895-016-0050-5.
Background: PubMed 40322860Brandao MPAS, Vieira CFO, Rocha DBB, Silva MR, da Silva JA, Gold MH, de Oliveira GV. Outcomes of a Non-Surgical Combination Therapy for Keloids in Skin of Color Patients: A 10-Year Follow-Up Study. Int J Dermatol. 2025 Aug;64(8):1434-1440. doi: 10.1111/ijd.17829. Epub 2025 May 5.
Background: PubMed 11493295de Oliveira GV, Nunes TA, Magna LA, Cintra ML, Kitten GT, Zarpellon S, Raposo Do Amaral CM. Silicone versus nonsilicone gel dressings: a controlled trial. Dermatol Surg. 2001 Aug;27(8):721-6. doi: 10.1046/j.1524-4725.2001.00345.x.
Background: PubMed 15720096Oliveira GV, Chinkes D, Mitchell C, Oliveras G, Hawkins HK, Herndon DN. Objective assessment of burn scar vascularity, erythema, pliability, thickness, and planimetry. Dermatol Surg. 2005 Jan;31(1):48-58. doi: 10.1111/j.1524-4725.2005.31004.
Background: PubMed 9556325Crowe 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.
Background: PubMed 2373734Sullivan T, Smith J, Kermode J, McIver E, Courtemanche DJ. Rating the burn scar. J Burn Care Rehabil. 1990 May-Jun;11(3):256-60. doi: 10.1097/00004630-199005000-00014.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing A.S.A.P. Algorithm in people with Keloid, run by Gisele Viana de Oliveira at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Vancouver Scar Scale (VSS) Score (time frame: Baseline and at least 6 months post-treatment initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07836569, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.