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Trial record 80 of 272 for:    Betamethasone

Nd:Yttrium Aluminum Garnet Laser Treatment for Lichen Sclerosus

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ClinicalTrials.gov Identifier: NCT03525522
Recruitment Status : Active, not recruiting
First Posted : May 15, 2018
Last Update Posted : May 15, 2018
Sponsor:
Collaborator:
Juna d.o.o.
Information provided by (Responsible Party):
Dr Adolf Lukanovič, University Medical Centre Ljubljana

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.

Condition or disease Intervention/treatment Phase
Lichen Sclerosus Lichen Sclerosus Et Atrophicus Device: Nd:YAG Laser Drug: Topical corticosteroid Diprosone Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients assigned randomly to two groups: laser-treatment group and topical-corticosteroid group.
Masking: Single (Outcomes Assessor)
Masking Description: Hystology and photographic assessment performed by independant investigators unaware of the assignement.
Primary Purpose: Treatment
Official Title: Efficacy of Nd:Yttrium Aluminum Garnet Laser Treatment of Lichen Sclerosus
Actual Study Start Date : January 28, 2016
Estimated Primary Completion Date : May 30, 2018
Estimated Study Completion Date : May 30, 2018


Arm Intervention/treatment
Experimental: Nd:YAG Laser
Three sessions of Nd:YAG laser (1064 nm) treatment with Dynamis (Fotona, Slovenia)
Device: Nd:YAG Laser
Three sessions of Nd:YAG treatment every two weeks.
Other Names:
  • Nd:YAG
  • neodymium
  • Dynamis

Active Comparator: Topical Corticosteroid Diprosone
Topical corticosteroid betamethasone (Diprosone, Merck Sharp & Dohme, d.o.o.) for 3 months.
Drug: Topical corticosteroid Diprosone
3 months of topical corticosteroids Diprosone
Other Name: topical corticosteroids betamethasone




Primary Outcome Measures :
  1. Change in Visual analog scale (VAS) score symptom evaluation from baseline to 3 months [ Time Frame: Change from baseline to 3 months ]
    Patients will evaluate symptoms on a 0-10 VAS scale


Secondary Outcome Measures :
  1. Change in Visual analog scale (VAS) score symptom evaluation from baseline to 1 month [ Time Frame: Change from baseline to 1 month ]
    Patients will evaluate symptoms on a 0-10 VAS scale

  2. Change in Visual analog scale (VAS) score symptom evaluation from baseline to 6 months [ Time Frame: Change from baseline to 6 months ]
    Patients will evaluate symptoms on a 0-10 VAS scale

  3. Comparative histological evaluation [ Time Frame: baseline and 3 months ]
    biopsies taken at baseline and after treatment

  4. patient satisfaction [ Time Frame: 1 month ]
    Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale.

  5. patient satisfaction [ Time Frame: 3 months ]
    Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale.

  6. patient satisfaction [ Time Frame: 6 months ]
    Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale.

  7. evaluation of improvement from clinical photographs [ Time Frame: 3 months ]
    by blinded evaluators on a 1-4 scale


Other Outcome Measures:
  1. tolerability of first laser treatment (pain and discomfort) on a 1-10 VAS scale [ Time Frame: day 0 (first laser treatment) ]
    rated by patients in the laser group on a 1-10 VAS scale

  2. tolerability of second laser treatment (pain and discomfort) on a 1-10 VAS scale [ Time Frame: day 14 (second laser treatment) ]
    rated by patients in the laser group on a 1-10 VAS scale

  3. tolerability of third laser treatment (pain and discomfort) on a 1-10 VAS scale [ Time Frame: 1 month (third laser treatment) ]
    rated by patients in the laser group on a 1-10 VAS scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03525522


Sponsors and Collaborators
Dr Adolf Lukanovič
Juna d.o.o.
Investigators
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Principal Investigator: Adolf Lukanović, PhD UKC Ljubljana

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Responsible Party: Dr Adolf Lukanovič, Medical Director of the Division of Gynaecology, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03525522     History of Changes
Other Study ID Numbers: Lichen_NdYAG
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Adolf Lukanovič, University Medical Centre Ljubljana:
Lichen sclerosus
laser
Nd:YAG
randomized controlled trial
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Lichen Sclerosus et Atrophicus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents