Clinical trial: Laser Therapy in Women With Lichenoid Disorders (NCT04697563)

Eligibility criteria:
Inclusion criteria

          -  women age >18 years

          -  diagnosed with LD (VLS or LP histologically proven)

          -  Clinical LS score ≥ 4 based on the score of Günthert et al. [1]

          -  Normal Pap-smear within 24 months

          -  negative clinical and microscopic evaluation of vaginal fluid

          -  Negative test for STD (sexually transmitted diseases) pathogens (chlamydia, gonorrhea,
             genital mycoplasma and trichomonas) if symptomic including abdominal pain or abnormal
             vaginal fluid

          -  Good German language skills

          -  written informed consent

          -  preceding local corticoid therapy of at least 12 weeks according to the current
             guideline for LD

        Exclusion criteria:

          -  women with contraindications for the use of laser on the skin

          -  pregnancy

          -  presence of vulvar pathology (other than lichen)

          -  any vulvar/ vaginal infection

          -  immunocompromised women

          -  swollen lymph nodes

          -  genital malignant disease

          -  allergy to topical anaesthesia

          -  connective tissue disease

          -  keloid formation

          -  Patients with a legal guardian

          -  Body Mass Index > 35 kg/m²

          -  History of transvaginal mesh implant (excluding sling or sacrocolpopexy mesh)

          -  Coagulopathy

          -  patients using anticoagulants

          -  patients with renal, hepatic or pulmonary-cardiovascular failure

          -  patients who have undergone any kind of organ transplantation in the last three years.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 99 Years

Patient description (medical language): A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers.  The rashes are mildly itchy. The patient has no other medical conditions and takes no medications.  Vital signs are normal.  On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer.  There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance.

Patient description (patient's own words): I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction.

Does the patient match the trial criteria? Contradiction