SUPERSTAR
Short-pulse and Ultra-Short Pulse ND: YAG 1064 Lasers for Stasis Dermatitis Secondary to Chronic Venous Hypertension Treatment: the SUPERSTAR Trial
Sponsor study identifier
interventional
20
1 country
1
Study Start
May 20, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 30, 2025
Actual (reported)May 20, 2025
Actual (reported)May 20, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
6 months
Photographic analysis
6 months
Number of participants with treatment-related adverse events as assessed by clinical evaluation.
6 months
DLQI - quality-of-life
6 months
Laser treatment
Laser treatment
Control vehicle (cold cream)
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).
Clinica Ramacciotti
Santo André, São Paulo, 09090401, Brazil
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.
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.
Eduardo Ramacciotti, MD, Ph.D, livre docente
Science Valley Research Institute
First Submitted
April 30, 2025
First Posted
May 20, 2025
Study Start
May 20, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
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).
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Bergan JJ, Schmid-Schonbein GW, Smith PD, Nicolaides AN, Boisseau MR, Eklof B. Chronic venous disease. N Engl J Med. 2006 Aug 3;355(5):488-98. doi: 10.1056/NEJMra055289. No abstract available.
October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 20, 2025
Record last verified: 2025-05
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.
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Source: ClinicalTrials.gov.
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