Stasis DermatitisSUPERSTARNCT06980961

Short and Ultra-short-pulse ND: YAG 1064nm Lasers (Omer Smart and Omer Premium) for Stasis Dermatitis

A study testing short-pulse ND: YAG 1064 laser, ultra-short-pulse ND: YAG 1064 laser and cold cream in people with Stasis Dermatitis, run by Science Valley Research Institute at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

This study tests two types of lasers (ND YAG 1064 short and ultra-short pulses) to treat hyperchromic skin lesions secondary to venous hypertension (stasis dermatitis) Read more about this study

Who is it for?: Any age
Conditions the study is for: Stasis Dermatitis
What is being tested?: short-pulse ND: YAG 1064 laser, ultra-short-pulse ND: YAG 1064 laser and cold cream
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteBrazil
Study dates: 20 May 2025to 1 Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Women or men aged 18 to 89 years with stasis dermatitis secondary to venous hypertension
Agreement with the terms of the survey and signing of the informed consent form
Availability to make the necessary appointments for treatment and follow-up
Provide consent to avoid pregnancy during treatment
Have primary venous hypertension already treated (treatment of varicose veins of the lower limbs) by any of the available techniques

Who cannot join

Men and women with CEAP 2 to 6, low mobility, no stasis dermatitis.
Peripheral arterial disease.
History of known allergy to the drugs used in this study
Presence of other types of dermatitis in the lower extremities, such as allergic stasis eczema.
Presence of comorbidities (such as diabetes mellitus, heart failure, respiratory failure, hypertension, hypothyroidism, or hyperthyroidism), pregnancy, breastfeeding, pulmonary hypertension, deep vein thrombosis (DVT), family history of DVT, known hypercoagulable states or thrombophilia, asthma, and migraine.
Anyone who does not agree with any of the search terms.
-

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Valéria Aguiar, MD contact

+5511950212099

val.aguiarvasc@gmail.com

Brazil1 site, 1 recruiting

Clinica Ramacciotti
Santo André, São Paulo, 09090401
Valeria Aguiar, MD, +55 11 95021-2099, val.aguiarvasc@gmail.com
Recruiting

Other trials in Brazil

About this study

Official title: Short-pulse and Ultra-Short Pulse ND: YAG 1064 Lasers for Stasis Dermatitis Secondary to Chronic Venous Hypertension Treatment: the SUPERSTAR Trial

This study tests two types of lasers (ND YAG 1064 short and ultra-short pulses) to treat hyperchromic skin lesions secondary to venous hypertension (stasis dermatitis)

Read the detailed description

Background: Stasis dermatitis with hyperpigmented skin lesions is a serious health problem for patients with chronic venous hypertension. Although no randomized studies have evaluated lasers for this treatment, lasers can be an attractive option.

Methods: This prospective, randomized, 3-arm, open-label, vehicle-controlled study will enroll patients scheduled to undergo treatment for stasis dermatitis with hyperpigmented skin lesions. Patients will be allocated to either Nd: YAG 1064 nm short pulse laser-nanoseconds (group 1), or Nd: YAG 1064 nm ultra-short-pulse laser-picoseconds (group 2), or cold cream vehicle control (group 3). All treatments are scheduled for 6 visits with pre-defined dates, with a final follow-up visit at intervals of 28 to 35 days. Primary outcomes include colorimetry analysis, secondary outcomes pre- and post-photographic analysis, and DLQI quality-of-life assessment.

Conclusions: The results of this trial will provide high-quality evidence to guide clinical practice on optimal management of hyperpigmented skin lesions secondary to stasis dermatitis.

Conditions: Stasis Dermatitis
Being tested: short-pulse ND: YAG 1064 laser, ultra-short-pulse ND: YAG 1064 laser, cold cream
Keywords: laser, stasis dermatitis, hyperchromic skin lesions

What participants receive

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

short-pulse ND: YAG 1064 laserProcedure or surgery
Also called Arm 1
Nd: YAG 1064 nm short pulse laser (5 nanoseconds), 4 mm spot size, from 100 to 1000 mJ total energy, treatment scheduled for six visits with pre-defined dates, with intervals of 28 to 35 days. The device will be Omer Smart, a Q-Switch Laser produced by Medical San (Lajeado, RS, Brazil).
ultra-short-pulse ND: YAG 1064 laserProcedure or surgery
Nd: YAG1064 nm ultra-short pulse laser (400 picoseconds), 2 to 10 mm spot size, from 100 to 1000 mJ total energy, treatment scheduled for 6 visits with pre-defined dates, with intervals of 28 to 35 days. The device will be Omer Premium, a picolaser produced by Medical San (Lajeado, RS, Brazil).
cold creamDrug
The control vehicle is a cold cream, supplied by HERVA'S manipulation pharmacy. The composition of cold cream will be beeswax, acetyl palmitate, BHA, cetearyl alcohol, propylparaben, and water. This topical agent will be applied to patients daily throughout the treatment period. It is scheduled for six visits with pre-defined dates, with intervals of 28 to 35 days.

Study groups in NCT06980961
Study group	Role	What they receive
Arm 1: ND YAG laser: 1064 nm short pulse (nanoseconds) - Omer Smart	Experimental	Laser treatment Receives: Procedure: short-pulse ND: YAG 1064 laser
Arm 2: ND YAG laser: 1064 nm ultra- short pulse (picoseconds) - omer Premium	Experimental	Laser treatment Receives: Procedure: ultra-short-pulse ND: YAG 1064 laser
Arm 3	Placebo comparator	Control vehicle (cold cream) Receives: Drug: cold cream

What is being measured

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

Colorimetry
The skin tone dissimilarity (expressed as ΔE) at treated and adjacent areas measured with digital calorimetry. The ΔE value derives from the differences in the International Commission on Illumination L*a*b* (CIELAB) color space. It is a structured approach to quantifying color differences, with specific intervals indicating varying levels of perceptibility with different intensities of pigmentation:
- 0 < ∆E < 1 - the difference is unnoticeable
- 1 < ∆E< 2 - the difference is only noticed by an experienced observer (mild),
- 2 < ∆E < 3.5 - the difference is also noticed by an inexperienced observer (light),
- 3.5 < ∆E < 5 - the difference is noticeable (moderate),
- 5 < ∆E - gives the impression that these are two different colors (intense) In all sessions, patients will be submitted to colorimetric analysis. The ∆E is the skin color difference between the treated and adjacent areas.
Measured: 6 months

Secondary outcomes (2)

Photographic analysis
The co-primary outcome will be the incidence of post-procedure skin hyperpigmentation improvement after six treatment sessions, evaluated through before-and-after photo documentation analysis by three experienced, independent, and blind observers.
All the evaluators will have access to high-definition before-and-after pictures of the patient's legs that were designated for them. Then, according to their expertise, they will answer the question, "Do you think there's post-treatment improvement in hyperpigmentation in the treated areas of this limb, yes or no?" for the affected limb. The answers chosen by most of the evaluators will be considered for data analysis.
Measured: 6 months
Number of participants with treatment-related adverse events as assessed by clinical evaluation.
Safety analysis will be carried out by clinical evaluation in all pre-scheduled visits. It includes clinical analysis of potential skin alterations such as abnormal redness, swelling, temporary changes in skin pigmentation (hyper- or hypopigmentation), petechia, scarring, or burns. It will be reported as the number of participants with treatment-related adverse events.
Measured: 6 months

Timeline

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

20 May 20251 Dec 2026

First posted20 May 2025
Study start20 May 2025 (estimated)
Primary completion1 Oct 2026 (estimated)
Study completion1 Dec 2026 (estimated)

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 Stasis DermatitisStudies 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: Randomised
Intervention model: Parallel groups
Model description: 3 arms parallel study
Masking: None (open label)
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06980961
Sponsor's protocol ID: SUPERSTAR trial
Acronym: SUPERSTAR
Status last verified: May 2025
First submitted: 30 Apr 2025
Last updated: 20 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Anonymized participant data can be made available upon requests directed to the corresponding author. Proposals will be reviewed based on scientific merit. After a proposal is approved, data can be shared through a secure online platform upon signing a data access agreement.

Publications

Vyas J, Johns JR, Ali FM, Ingram JR, Salek S, Finlay AY. A Systematic Review of 207 Studies Describing Validation Aspects of the Dermatology Life Quality Index. Acta Derm Venereol. 2024 Nov 7;104:adv41120. doi: 10.2340/actadv.v104.41120.
PubMed 39508500
Liu C, Huang HY, Chang YY, Sun CK, Chia SH, Liao YH. Optical Effects of Focused Fractional Nanosecond 1064-nm Nd:YAG Laser: Techniques of Application on Human Skin. Lasers Surg Med. 2024 Aug;56(6):557-563. doi: 10.1002/lsm.23812. Epub 2024 Jun 18.
PubMed 38890780
Ma S, Zhu H, Chen J, Chen F, Wu Y, He S, Li Y, Gong Y, Zhu H. Analysis of efficacy of picosecond laser treatment for nevus of Ota. Lasers Med Sci. 2025 Feb 6;40(1):72. doi: 10.1007/s10103-025-04322-0.
PubMed 39913065
Silverberg JI, Kirsner RS, Margolis DJ, Tharp M, Myers DE, Annis K, Graham D, Zang C, Vlahos BL, Sanders P. Efficacy and safety of crisaborole ointment, 2%, in participants aged >/=45 years with stasis dermatitis: Results from a fully decentralized, randomized, proof-of-concept phase 2a study. J Am Acad Dermatol. 2024 May;90(5):945-952. doi: 10.1016/j.jaad.2023.12.048. Epub 2024 Feb 8.
PubMed 38340127
Shriver MD, Parra EJ. Comparison of narrow-band reflectance spectroscopy and tristimulus colorimetry for measurements of skin and hair color in persons of different biological ancestry. Am J Phys Anthropol. 2000 May;112(1):17-27. doi: 10.1002/(SICI)1096-8644(200005)112:13.0.CO;2-D.
PubMed 10766940
Basra MK, Chowdhury MM, Smith EV, Freemantle N, Piguet V. A review of the use of the dermatology life quality index as a criterion in clinical guidelines and health technology assessments in psoriasis and chronic hand eczema. Dermatol Clin. 2012 Apr;30(2):237-44, viii. doi: 10.1016/j.det.2011.11.002. Epub 2011 Dec 21.
PubMed 22284138
Weatherall IL, Coombs BD. Skin color measurements in terms of CIELAB color space values. J Invest Dermatol. 1992 Oct;99(4):468-73. doi: 10.1111/1523-1747.ep12616156.
PubMed 1402005
Ly BCK, Dyer EB, Feig JL, Chien AL, Del Bino S. Research Techniques Made Simple: Cutaneous Colorimetry: A Reliable Technique for Objective Skin Color Measurement. J Invest Dermatol. 2020 Jan;140(1):3-12.e1. doi: 10.1016/j.jid.2019.11.003.
PubMed 31864431
Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
PubMed 8033378
Liu J, Han C, Feng X, Liang J, Qu Y. Effective Picosecond Nd:YAG laser on seborrheic dermatitis and its mechanism. J Cosmet Dermatol. 2022 Jun;21(6):2449-2457. doi: 10.1111/jocd.14414. Epub 2021 Sep 8.
PubMed 34496116
Eichenfield LF, Tom WL, Berger TG, Krol A, Paller AS, Schwarzenberger K, Bergman JN, Chamlin SL, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Margolis DJ, Silverman RA, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014 Jul;71(1):116-32. doi: 10.1016/j.jaad.2014.03.023. Epub 2014 May 9.
PubMed 24813302
Dissemond J, Knab J, Lehnen M, Franckson T, Goos M. Successful treatment of stasis dermatitis with topical tacrolimus. Vasa. 2004 Nov;33(4):260-2. doi: 10.1024/0301-1526.33.4.260.
PubMed 15623206
Silverberg JI, Hou A, Warshaw EM, Maibach HI, Belsito DV, DeKoven JG, Zug KA, Taylor JS, Sasseville D, Fransway AF, DeLeo VA, Pratt MD, Reeder MJ, Atwater AR, Fowler JF Jr, Zirwas MJ, Marks JG Jr. Prevalence and trend of allergen sensitization in patients with a diagnosis of stasis dermatitis referred for patch testing, North American contact dermatitis group data, 2001-2016. Arch Dermatol Res. 2022 Nov;314(9):857-867. doi: 10.1007/s00403-021-02295-y. Epub 2021 Nov 8.
PubMed 34748058
Sundaresan S, Migden MR, Silapunt S. Stasis Dermatitis: Pathophysiology, Evaluation, and Management. Am J Clin Dermatol. 2017 Jun;18(3):383-390. doi: 10.1007/s40257-016-0250-0.
PubMed 28063094
Abbade LP, Lastoria S, Rollo Hde A. Venous ulcer: clinical characteristics and risk factors. Int J Dermatol. 2011 Apr;50(4):405-11. doi: 10.1111/j.1365-4632.2010.04654.x.
PubMed 21413949

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Short-pulse and Ultra-Short Pulse ND: YAG 1064 Lasers for Stasis Dermatitis Secondary to Chronic Venous Hypertension Treatment: the SUPERSTAR Trial
ClinicalTrials.gov ID: NCT06980961
Acronym / sponsor ID: SUPERSTAR / SUPERSTAR trial
Conditions: Stasis Dermatitis
Keywords: laser, stasis dermatitis, hyperchromic skin lesions
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 20 participants (estimated)
Lead sponsor: Science Valley Research InstituteUniversity, hospital or other
Study start: 20 May 2025 (estimated)
Primary completion: 1 Oct 2026 (estimated)
Study completion: 1 Dec 2026 (estimated)
First posted: 20 May 2025 (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.

This study tests two types of lasers (ND YAG 1064 short and ultra-short pulses) to treat hyperchromic skin lesions secondary to venous hypertension (stasis dermatitis)

Detailed description

Conclusions: The results of this trial will provide high-quality evidence to guide clinical practice on optimal management of hyperpigmented skin lesions secondary to stasis dermatitis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: 3 arms parallel study

Arm	Type	Receives
Arm 1: ND YAG laser: 1064 nm short pulse (nanoseconds) - Omer Smart	Experimental	Procedure: short-pulse ND: YAG 1064 laserLaser treatment
Arm 2: ND YAG laser: 1064 nm ultra- short pulse (picoseconds) - omer Premium	Experimental	Procedure: ultra-short-pulse ND: YAG 1064 laserLaser treatment
Arm 3	Placebo comparator	Drug: cold creamControl vehicle (cold cream)

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Women or men aged 18 to 89 years with stasis dermatitis secondary to venous hypertension
Agreement with the terms of the survey and signing of the informed consent form
Availability to make the necessary appointments for treatment and follow-up
Provide consent to avoid pregnancy during treatment
Have primary venous hypertension already treated (treatment of varicose veins of the lower limbs) by any of the available techniques

Key exclusion criteria (7 listed)

Men and women with CEAP 2 to 6, low mobility, no stasis dermatitis.
Peripheral arterial disease.
History of known allergy to the drugs used in this study
Presence of other types of dermatitis in the lower extremities, such as allergic stasis eczema.
Presence of comorbidities (such as diabetes mellitus, heart failure, respiratory failure, hypertension, hypothyroidism, or hyperthyroidism), pregnancy, breastfeeding, pulmonary hypertension, deep vein thrombosis (DVT), family history of DVT, known hypercoagulable states or thrombophilia, asthma, and migraine.

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
short-pulse ND: YAG 1064 laserAlso: Arm 1Nd: YAG 1064 nm short pulse laser (5 nanoseconds), 4 mm spot size, from 100 to 1000 mJ total energy, treatment scheduled for six visits with pre-defined dates, with intervals of 28 to 35 days. The device will be Omer Smart, a Q-Switch Laser produced by Medical San (Lajeado, RS, Brazil).	Procedure or surgery	Arm 1: ND YAG laser: 1064 nm short pulse (nanoseconds) - Omer Smart
ultra-short-pulse ND: YAG 1064 laserNd: YAG1064 nm ultra-short pulse laser (400 picoseconds), 2 to 10 mm spot size, from 100 to 1000 mJ total energy, treatment scheduled for 6 visits with pre-defined dates, with intervals of 28 to 35 days. The device will be Omer Premium, a picolaser produced by Medical San (Lajeado, RS, Brazil).	Procedure or surgery	Arm 2: ND YAG laser: 1064 nm ultra- short pulse (picoseconds) - omer Premium
cold creamThe control vehicle is a cold cream, supplied by HERVA'S manipulation pharmacy. The composition of cold cream will be beeswax, acetyl palmitate, BHA, cetearyl alcohol, propylparaben, and water. This topical agent will be applied to patients daily throughout the treatment period. It is scheduled for six visits with pre-defined dates, with intervals of 28 to 35 days.	Drug	Arm 3

Primary outcome

Colorimetry
Time frame: 6 months
The skin tone dissimilarity (expressed as ΔE) at treated and adjacent areas measured with digital calorimetry. The ΔE value derives from the differences in the International Commission on Illumination L*a*b* (CIELAB) color space. It is a structured approach to quantifying color differences, with specific intervals indicating varying levels of perceptibility with different intensities of pigmentation: * 0 < ∆E < 1 - the difference is unnoticeable * 1 < ∆E< 2 - the difference is only noticed by an experienced observer (mild), * 2 < ∆E < 3.5 - the difference is also noticed by an inexperienced observer (light), * 3.5 < ∆E < 5 - the difference is noticeable (moderate), * 5 < ∆E - gives the impression that these are two different colors (intense) In all sessions, patients will be submitted to colorimetric analysis. The ∆E is the skin color difference between the treated and adjacent areas.

2 secondary outcomes

Photographic analysis
Time frame: 6 months
Number of participants with treatment-related adverse events as assessed by clinical evaluation.
Time frame: 6 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
Background: PubMed 39508500Vyas J, Johns JR, Ali FM, Ingram JR, Salek S, Finlay AY. A Systematic Review of 207 Studies Describing Validation Aspects of the Dermatology Life Quality Index. Acta Derm Venereol. 2024 Nov 7;104:adv41120. doi: 10.2340/actadv.v104.41120.
Background: PubMed 38890780Liu C, Huang HY, Chang YY, Sun CK, Chia SH, Liao YH. Optical Effects of Focused Fractional Nanosecond 1064-nm Nd:YAG Laser: Techniques of Application on Human Skin. Lasers Surg Med. 2024 Aug;56(6):557-563. doi: 10.1002/lsm.23812. Epub 2024 Jun 18.
Background: PubMed 39913065Ma S, Zhu H, Chen J, Chen F, Wu Y, He S, Li Y, Gong Y, Zhu H. Analysis of efficacy of picosecond laser treatment for nevus of Ota. Lasers Med Sci. 2025 Feb 6;40(1):72. doi: 10.1007/s10103-025-04322-0.
Background: PubMed 38340127Silverberg JI, Kirsner RS, Margolis DJ, Tharp M, Myers DE, Annis K, Graham D, Zang C, Vlahos BL, Sanders P. Efficacy and safety of crisaborole ointment, 2%, in participants aged >/=45 years with stasis dermatitis: Results from a fully decentralized, randomized, proof-of-concept phase 2a study. J Am Acad Dermatol. 2024 May;90(5):945-952. doi: 10.1016/j.jaad.2023.12.048. Epub 2024 Feb 8.
Background: PubMed 10766940Shriver MD, Parra EJ. Comparison of narrow-band reflectance spectroscopy and tristimulus colorimetry for measurements of skin and hair color in persons of different biological ancestry. Am J Phys Anthropol. 2000 May;112(1):17-27. doi: 10.1002/(SICI)1096-8644(200005)112:13.0.CO;2-D.
Background: PubMed 22284138Basra MK, Chowdhury MM, Smith EV, Freemantle N, Piguet V. A review of the use of the dermatology life quality index as a criterion in clinical guidelines and health technology assessments in psoriasis and chronic hand eczema. Dermatol Clin. 2012 Apr;30(2):237-44, viii. doi: 10.1016/j.det.2011.11.002. Epub 2011 Dec 21.
Background: PubMed 1402005Weatherall IL, Coombs BD. Skin color measurements in terms of CIELAB color space values. J Invest Dermatol. 1992 Oct;99(4):468-73. doi: 10.1111/1523-1747.ep12616156.
Background: PubMed 31864431Ly BCK, Dyer EB, Feig JL, Chien AL, Del Bino S. Research Techniques Made Simple: Cutaneous Colorimetry: A Reliable Technique for Objective Skin Color Measurement. J Invest Dermatol. 2020 Jan;140(1):3-12.e1. doi: 10.1016/j.jid.2019.11.003.
Background: PubMed 8033378Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
Background: PubMed 34496116Liu J, Han C, Feng X, Liang J, Qu Y. Effective Picosecond Nd:YAG laser on seborrheic dermatitis and its mechanism. J Cosmet Dermatol. 2022 Jun;21(6):2449-2457. doi: 10.1111/jocd.14414. Epub 2021 Sep 8.
Background: PubMed 24813302Eichenfield LF, Tom WL, Berger TG, Krol A, Paller AS, Schwarzenberger K, Bergman JN, Chamlin SL, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Margolis DJ, Silverman RA, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014 Jul;71(1):116-32. doi: 10.1016/j.jaad.2014.03.023. Epub 2014 May 9.
Background: PubMed 15623206Dissemond J, Knab J, Lehnen M, Franckson T, Goos M. Successful treatment of stasis dermatitis with topical tacrolimus. Vasa. 2004 Nov;33(4):260-2. doi: 10.1024/0301-1526.33.4.260.
Individual participant dataSharing planned: Yes. Anonymized participant data can be made available upon requests directed to the corresponding author. Proposals will be reviewed based on scientific merit. After a proposal is approved, data can be shared through a secure online platform upon signing a data access agreement.

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.

Valéria Aguiar, MD contact

+5511950212099

val.aguiarvasc@gmail.com

Eduardo Ramacciotti, MD, Ph.D, livre docente study chair

Science Valley Research Institute

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

Questions about this trial

What is this clinical trial studying?

A study testing short-pulse ND: YAG 1064 laser, ultra-short-pulse ND: YAG 1064 laser and cold cream in people with Stasis Dermatitis, run by Science Valley Research Institute 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 20 May 2025. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Valéria Aguiar, MD (+5511950212099, val.aguiarvasc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Colorimetry (time frame: 6 months). 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 NCT06980961, 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 20 May 2025.