Nd:Yttrium Aluminum Garnet Laser Treatment for Lichen Sclerosus

NCT03525522 | Unknown

• 1 other identifier: Lichen_NdYAG
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the efficacy of Nd:Yttrium Aluminum Garnet Laser (Nd:YAG) Treatment of Lichen sclerosus in comparison with topical corticosteroid treatment. Half of participants will receive laser treatment and the other half corticosteroid treatment and the results will be followed for 6 months.

Conditions

Lichen Sclerosus; Lichen Sclerosus Et Atrophicus

Keywords

Lichen sclerosus; laser; Nd:YAG; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in Visual analog scale (VAS) score symptom evaluation from baseline to 3 months

  Patients will evaluate symptoms on a 0-10 VAS scale

  Change from baseline to 3 months

Secondary Outcomes (7)

• Change in Visual analog scale (VAS) score symptom evaluation from baseline to 1 month

  Change from baseline to 1 month

• Change in Visual analog scale (VAS) score symptom evaluation from baseline to 6 months

  Change from baseline to 6 months

• Comparative histological evaluation

  baseline and 3 months

• patient satisfaction

  1 month

• patient satisfaction

  3 months

Other Outcomes (3)

• tolerability of first laser treatment (pain and discomfort) on a 1-10 VAS scale

  day 0 (first laser treatment)

• tolerability of second laser treatment (pain and discomfort) on a 1-10 VAS scale

  day 14 (second laser treatment)

• tolerability of third laser treatment (pain and discomfort) on a 1-10 VAS scale

  1 month (third laser treatment)

Study Arms (2)

Nd:YAG Laser

EXPERIMENTAL

Three sessions of Nd:YAG laser (1064 nm) treatment with Dynamis (Fotona, Slovenia)

Device: Nd:YAG Laser

Topical Corticosteroid Diprosone

ACTIVE COMPARATOR

Topical corticosteroid betamethasone (Diprosone, Merck Sharp \& Dohme, d.o.o.) for 3 months.

Drug: Topical corticosteroid Diprosone

Interventions

Nd:YAG Laser DEVICE

Three sessions of Nd:YAG treatment every two weeks.

Also known as: Nd:YAG, neodymium, Dynamis

Nd:YAG Laser

Topical corticosteroid Diprosone DRUG

3 months of topical corticosteroids Diprosone

Also known as: topical corticosteroids betamethasone

Topical Corticosteroid Diprosone

Eligibility Criteria

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

You may qualify if:

• histologically confirmed Lichen sclerosus
• voluntary signed informed consent

You may not qualify if:

• pregnancy
• use of photosensitizing medication
• pathology other than Lichen
• damage of tissues in the treatment area
• other inflammation
• refusal to sign informed consent

Sponsors & Collaborators

• Dr Adolf Lukanovič: lead
• Juna d.o.o.: collaborator

MeSH Terms

Conditions

Lichen Sclerosus et Atrophicus

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Adolf Lukanović, PhD

  UKC Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Hystology and photographic assessment performed by independant investigators unaware of the assignement.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director of the Division of Gynaecology

Model Details: Patients assigned randomly to two groups: laser-treatment group and topical-corticosteroid group.

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: May 15, 2018
• Study Start: January 28, 2016
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: May 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share