Nd:Yttrium Aluminum Garnet Laser Treatment for Lichen Sclerosus

Lichen Sclerosus Clinical Trial

Official title:

Efficacy of Nd:Yttrium Aluminum Garnet Laser Treatment of Lichen Sclerosus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03525522
• Other study ID #: Lichen_NdYAG
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 28, 2016
• Est. completion date: May 30, 2018

Study information

• Verified date: May 2018
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Lichen sclerosus (LS) is a chronic skin disease of unknown cause and very unpleasant symptoms which significantly influences the quality of life of the affected patients. Large majority of LS lesions is located in anogenital region where initial white flat papules usually develop into large, white patches of thin, itchy skin causing fusion of labia minora, narrowing of the introitus and burying of the clitoris. Most common symptoms are itching, pain, soreness, burning, dyspareunia and dysuria all strongly interfering with sexual function and patient's self image. Existing treatment options with systemic and topical medications (oral retinoids, topical steroids) have some drawbacks and recently the use of laser was proposed for treatment of LS. This study evaluates the safety and 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• histologically confirmed Lichen sclerosus

• voluntary signed informed consent

Exclusion Criteria:

• pregnancy

• use of photosensitizing medication

• pathology other than Lichen

• damage of tissues in the treatment area

• other inflammation

• refusal to sign informed consent

Related Conditions & MeSH terms

• Lichen Sclerosus
• Lichen Sclerosus Et Atrophicus

Intervention

Device:
• Nd:YAG Laser
Three sessions of Nd:YAG treatment every two weeks.

Drug:
• Topical corticosteroid Diprosone
3 months of topical corticosteroids Diprosone

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Dr Adolf Lukanovic	Juna d.o.o.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	tolerability of first laser treatment (pain and discomfort) on a 1-10 VAS scale	rated by patients in the laser group on a 1-10 VAS scale	day 0 (first laser treatment)
Other	tolerability of second laser treatment (pain and discomfort) on a 1-10 VAS scale	rated by patients in the laser group on a 1-10 VAS scale	day 14 (second laser treatment)
Other	tolerability of third laser treatment (pain and discomfort) on a 1-10 VAS scale	rated by patients in the laser group on a 1-10 VAS scale	1 month (third laser treatment)
Primary	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	Change in Visual analog scale (VAS) score symptom evaluation from baseline to 1 month	Patients will evaluate symptoms on a 0-10 VAS scale	Change from baseline to 1 month
Secondary	Change in Visual analog scale (VAS) score symptom evaluation from baseline to 6 months	Patients will evaluate symptoms on a 0-10 VAS scale	Change from baseline to 6 months
Secondary	Comparative histological evaluation	biopsies taken at baseline and after treatment	baseline and 3 months
Secondary	patient satisfaction	Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale.	1 month
Secondary	patient satisfaction	Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale.	3 months
Secondary	patient satisfaction	Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale.	6 months
Secondary	evaluation of improvement from clinical photographs	by blinded evaluators on a 1-4 scale	3 months