An interventional study of Nd:YAG Laser and Topical corticosteroid Diprosone in Lichen Sclerosus and Lichen Sclerosus Et Atrophicus, sponsored by Dr Adolf Lukanovič. Status unknown. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-15.
Sponsored by Dr Adolf Lukanovič · Not applicable, Interventional, and Treatment
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.
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.
30 studies on the registry are indexed under Lichen Sclerosus et Atrophicus; 8 are open to participants now.
This study's planned enrollment of 40 is below the median of 45 across 20 interventional studies indexed under Lichen Sclerosus et Atrophicus.
Browse Lichen Sclerosus et Atrophicus studies →Dr Adolf Lukanovič is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Three sessions of Nd:YAG laser (1064 nm) treatment with Dynamis (Fotona, Slovenia)
Device: Nd:YAG Laser
Topical corticosteroid betamethasone (Diprosone, Merck Sharp \& Dohme, d.o.o.) for 3 months.
Drug: Topical corticosteroid Diprosone
Three sessions of Nd:YAG treatment every two weeks.
Also known as: Nd:YAG, neodymium, Dynamis
3 months of topical corticosteroids Diprosone
Also known as: topical corticosteroids betamethasone
Change in Visual analog scale (VAS) score symptom evaluation from baseline to 3 months
Patients will evaluate symptoms on a 0-10 VAS scale
Time frame: Change from baseline to 3 months
Change in Visual analog scale (VAS) score symptom evaluation from baseline to 1 month
Patients will evaluate symptoms on a 0-10 VAS scale
Time frame: Change from baseline to 1 month
Change in Visual analog scale (VAS) score symptom evaluation from baseline to 6 months
Patients will evaluate symptoms on a 0-10 VAS scale
Time frame: Change from baseline to 6 months
Comparative histological evaluation
biopsies taken at baseline and after treatment
Time frame: baseline and 3 months
patient satisfaction
Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale.
Time frame: 1 month
patient satisfaction
Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale.
Time frame: 3 months
patient satisfaction
Patients will indicate their satisfaction with the outcome of treatment on a 0-3 scale.
Time frame: 6 months
evaluation of improvement from clinical photographs
by blinded evaluators on a 1-4 scale
Time frame: 3 months
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
Time frame: day 0 (first laser treatment)
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
Time frame: day 14 (second laser treatment)
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
Time frame: 1 month (third laser treatment)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2016 (actual). Primary completion is estimated for May 2018, 28 months after the start.
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This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Lichen Sclerosus et Atrophicus →
Dr Adolf Lukanovič