UVA-1 for Treatment of Skin Tightening and Improvement of Hand Function in Scleroderma

NCT04875078 | Enrolling By Invitation FDA Device

• 1 other identifier: IRB_00134454
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

UVA-1 has been reported to be beneficial to skin changes in scleroderma in several case reports and a few small studies. (Jacobe 2020) Interpretation of these reports has been difficult based on the small numbers of subjects involved and the non-blinded non-randomized nature of the reports. In a single controlled study with half-side comparison of 9 patients, the investigators could not demonstrate improvement with UVA-1 in the treated hand. (Thomas 2007) This study was limited by a small number of patients and the long disease duration prior to treatment (mean of 13 years). A more recent report of a patient with scleroderma for 2.5 years and severe acrosclerosis that responded to 21 sessions of UVA-1 with improved mobility and functionality renews interest in this treatment modality. (Cuenca-Barrales 2019) In this trial patients will be randomized to have their dominant or non-dominant hand undergo 30 sessions of UVA1 therapy . We will assess patient's hand mobility, hand function, skin hardening (assessed by durometer measurements), skin thickness, as well as patient reported outcomes to determine efficacy. This study will use a single-blind, prospective, randomized (dominant/non-dominant hand) comparator design to assess the effect of high dose (80-120 J/cm2) UVA1 therapy on hand function in scleroderma in a paired t-test design. This study will be placebo-controlled (with a UV-blocking gloved hand), cross-over, randomized clinical trial. Following the initial treatment period (30 treatments), patients will have the option to undergo the same high dose UVA1 treatment protocol on the untreated control hand. A follow up period of 12 months following completion of UVA1 therapy will prospectively follow patients to monitor for relapse of their disease to assess the durability of the clinical response to UVA1 therapy on hand scleroderma.

Conditions

Scleroderma

Outcome Measures

Primary Outcomes (1)

• HAMIS score of treated hand compared to the HAMIS score of the untreated hand after 30 UVA-1 treatments have been completed.

  HAMIS graded on a 0-3 scale, where 0 corresponds to normal function and 3 denotes that the individual is unable to perform the item.

  Approximately 100 days

Secondary Outcomes (8)

• Change in HAMIS score from baseline to after 30 UVA-1 treatments of treated hand.

  Approximately 100 days

• Change in CHFDS score from baseline to after 30 UVA-1 treatments of treated hand.

  Approximately 100 days

• Change in skin hardness from baseline to after 30 UVA-1 treatments of treated hand.

  Approximately 100 days

• Change in skin thickness from baseline to after 30 UVA-1 treatments of treated hand.

  Approximately 100 days

• Change in Skindex-16 score from baseline to after 30 UVA-1 treatments of treated hand.

  Approximately 100 days

Study Arms (2)

UVA-1 Treated hand

EXPERIMENTAL

This hand will be treated with UVA-1 phototherapy.

Device: UVA-1 Phototherapy

The untreated hand

NO INTERVENTION

This hand will be gloved when the patient undergoes UVA-1 phototherapy treatments.

Interventions

UVA-1 Phototherapy DEVICE

UVA-1 Phototherapy treatments

UVA-1 Treated hand

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be able to understand and provide written informed consent
• Scleroderma skin involvement affecting both hands approximately equally
• Age of at least 18-years-old
• Male or female
• Ability to engage in twice weekly UVA1 sessions
• No changes in systemic therapy during the first 100 days of the study period

You may not qualify if:

• On photosensitizing medication
• Inability to complete study visits
• UV light therapy in the 4 weeks prior to entering the study
• Commercial tanning or excessive sun exposure in the 4 weeks prior to entering the study
• Current pregnancy or planned pregnancy during the study period
• Use of topical therapies other than emollients (suprapotent corticosteroids) in the 2 weeks prior to entering the study
• History of intolerance to ultraviolet light
• Any other condition that will disqualify the patient from the study in the opinion of the investigator

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah MidValley Dermatology

Murray, Utah, 84107, United States

Location

Related Publications (12)

• Hassani J, Feldman SR. Phototherapy in Scleroderma. Dermatol Ther (Heidelb). 2016 Dec;6(4):519-553. doi: 10.1007/s13555-016-0136-3. Epub 2016 Aug 12.

  PMID: 27519050 BACKGROUND

• Sandler RD, Matucci-Cerinic M, Hughes M. Musculoskeletal hand involvement in systemic sclerosis. Semin Arthritis Rheum. 2020 Apr;50(2):329-334. doi: 10.1016/j.semarthrit.2019.11.003. Epub 2019 Nov 9.

  PMID: 31812353 BACKGROUND

• Guillaume-Jugnot P, Daumas A, Magalon J, Jouve E, Nguyen PS, Truillet R, Mallet S, Casanova D, Giraudo L, Veran J, Dignat-George F, Sabatier F, Magalon G, Granel B. Autologous adipose-derived stromal vascular fraction in patients with systemic sclerosis: 12-month follow-up. Rheumatology (Oxford). 2016 Feb;55(2):301-6. doi: 10.1093/rheumatology/kev323. Epub 2015 Sep 8.

  PMID: 26350489 BACKGROUND

• Liem SIE, Vliet Vlieland TPM, Schoones JW, de Vries-Bouwstra JK. The effect and safety of exercise therapy in patients with systemic sclerosis: a systematic review. Rheumatol Adv Pract. 2019 Dec 9;3(2):rkz044. doi: 10.1093/rap/rkz044. eCollection 2019.

  PMID: 31858074 BACKGROUND

• Connolly KL, Griffith JL, McEvoy M, Lim HW. Ultraviolet A1 phototherapy beyond morphea: experience in 83 patients. Photodermatol Photoimmunol Photomed. 2015 Nov;31(6):289-95. doi: 10.1111/phpp.12185. Epub 2015 Jun 26.

  PMID: 26052743 BACKGROUND

• Kroft EB, van de Kerkhof PC, Gerritsen MJ, de Jong EM. Period of remission after treatment with UVA-1 in sclerodermic skin diseases. J Eur Acad Dermatol Venereol. 2008 Jul;22(7):839-44. doi: 10.1111/j.1468-3083.2007.02576.x. Epub 2008 Apr 30.

  PMID: 18452527 BACKGROUND

• Bongi SM, Del Rosso A, Galluccio F, Sigismondi F, Miniati I, Conforti ML, Nacci F, Cerinic MM. Efficacy of connective tissue massage and Mc Mennell joint manipulation in the rehabilitative treatment of the hands in systemic sclerosis. Clin Rheumatol. 2009 Oct;28(10):1167-73. doi: 10.1007/s10067-009-1216-x. Epub 2009 Jun 25.

  PMID: 19554274 BACKGROUND

• Sandqvist G, Eklund M. Hand Mobility in Scleroderma (HAMIS) test: the reliability of a novel hand function test. Arthritis Care Res. 2000 Dec;13(6):369-74.

  PMID: 14635312 BACKGROUND

• Khanna D, Furst DE, Clements PJ, Allanore Y, Baron M, Czirjak L, Distler O, Foeldvari I, Kuwana M, Matucci-Cerinic M, Mayes M, Medsger T Jr, Merkel PA, Pope JE, Seibold JR, Steen V, Stevens W, Denton CP. Standardization of the modified Rodnan skin score for use in clinical trials of systemic sclerosis. J Scleroderma Relat Disord. 2017 Jan-Apr;2(1):11-18. doi: 10.5301/jsrd.5000231.

  PMID: 28516167 BACKGROUND

• Prasad S, Coias J, Chen HW, Jacobe H. Utilizing UVA-1 Phototherapy. Dermatol Clin. 2020 Jan;38(1):79-90. doi: 10.1016/j.det.2019.08.011.

  PMID: 31753195 BACKGROUND

• Kreuter A, Hyun J, Stucker M, Sommer A, Altmeyer P, Gambichler T. A randomized controlled study of low-dose UVA1, medium-dose UVA1, and narrowband UVB phototherapy in the treatment of localized scleroderma. J Am Acad Dermatol. 2006 Mar;54(3):440-7. doi: 10.1016/j.jaad.2005.11.1063. Epub 2006 Jan 30.

  PMID: 16488295 BACKGROUND

• Mouthon L, Poiraudeau S, Vernon M, Papadakis K, Perchenet L, Khanna D. Psychometric validation of the Hand Disability in Systemic Sclerosis-Digital Ulcers (HDISS-DU(R)) patient-reported outcome instrument. Arthritis Res Ther. 2020 Jan 6;22(1):3. doi: 10.1186/s13075-019-2087-4.

  PMID: 31907061 BACKGROUND

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator will be blinded to which hand was treated, and be the blinded assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Treated hand compared to non-treated hand

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 6, 2021
• Study Start: December 12, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)