Vulvar Lichen Sclerosus: Comparison Between Clobetasol Propionate, Photodynamic Therapy and Low-Intensity Laser

NCT02416531 | Completed

• 1 other identifier: Lichen-768168
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Vulvar lichen sclerosus (VLS) is a lymphocyte-mediated disease of unknown etiology that can cause intense itching as well stenosis, hindering the evacuation and urination. It can also limit the sex life due to severe local pruritus, pain and dyspareunia (pain during sexual intercourse). The standard treatment for this disease is the use of topical corticosteroids to reduce the clinical symptoms and to try to increase disease-free intervals. Photodynamic therapy (PDT), a treatment that associates a light radiation with a photosensitizing agent and low-level laser therapy (LLLT) are therapies that can promote effective immunomodulatory responses at the application site by means of photophysical and photochemical phenomena from the molecular to the systemic level, which promote their use in chronic dermatoses. The aim is to study and compare the effects of PDT, LLLT, and topical corticosteroid in VLS evaluating clinical, histological, immunohistochemical and spectroscopic responses. The study will be prospective, randomized, and controlled, in a population of 60 women with histological diagnoses of VLS, enrolled on the outpatient clinic of Genitoscopy Department of the Pérola Byington Hospital in São Paulo. There will be 3 treatments groups: PDT, LLLT and topical corticosteroid, where will be allocated by randomization 20 patients in each one. The clinical course will be monitored by measuring local temperature, itching, clamping (atrophy), and the appearance of the lesion. Histologically, the slides will be classified according to the Hewitt grading and will have the ordering of collagen fibers quantified. Immunohistochemical analysis will be done using the markers IFN-γ, TGF-β, CD4, CD8, IL-1, p53 and Ki-67. Finally, the spectroscopic evaluation will be done by reflectance. Descriptive and inferential statistical analyses will be conducted to compare the groups and for associations between different responses.

Conditions

Vulvar Lichen Sclerosus

Keywords

Vulvar lichen sclerosus; Photodynamic therapy; Low-level laser therapy; Clobetasol propionate

Outcome Measures

Primary Outcomes (1)

• Change from baseline in biopsies at 1 month.

  Biopsies will be performed at two points: at baseline to confirm the VLS and subsequent inclusion in the research protocol, and at the end of 30 days to investigate the prognosis after treatment.

  Participants will be followed for 1 month during VLS's treatment.

Secondary Outcomes (7)

• Count cells per mm2 by immunohistochemical reaction of IFN-γ, TGF-β, CD4, CD8, IL-1, p53 and Ki-67.

  Participants will be followed for 1 month during VLS's treatment.

• Percentage of relative reflectance as assessed by In-Vivo Reflectance Spectroscopy.

  Participants will be followed for 1 month during VLS's treatment.

• Temperature, as assessed by infrared thermographic camera, in Celsius degrees.

  Participants will be followed for 1 month during VLS's treatment.

• Itching, as assessed by Visual Analog Scale.

  Participants will be followed for 1 month during VLS's treatment.

• Clamping, as assessed by digital caliper, in mm.

  Participants will be followed for 1 month during VLS's treatment.

Study Arms (3)

Corticosteroid

ACTIVE COMPARATOR

Clobetasol propionate 0.05% ointment applied once daily at a dose of 1 g/application (1 g sachets) for 4 weeks.

Drug: Clobetasol propionate

Photodynamic therapy

EXPERIMENTAL

Methylene blue 0.01% intralesional, λ = 660 ± 10 nm, P = 100 mW, PD = 510 mW/cm2, E = 4 J, ED = 20 J/cm2, t = 40 s, once a week for 4 weeks.

Radiation: Photodynamic therapy

Low level laser therapy

EXPERIMENTAL

λ = 660 ± 10 nm, P = 100 mW, PD = 510 mW/cm2, E = 4 J, ED = 20 J/cm2, t = 40 s, once a week for 4 weeks.

Radiation: Low level laser therapy

Interventions

Clobetasol propionate DRUG

Clobetasol propionate 0.05% ointment applied once daily at a dose of 1 g/application (1 g sachets) for 4 weeks.

Also known as: Corticosteroid

Corticosteroid

Photodynamic therapy RADIATION

Methylene blue 0.01% intralesional, λ = 660 ± 10 nm, P = 100 mW, PD = 510 mW/cm2, E = 4 J, ED = 20 J/cm2, t = 40 s, once a week for 4 weeks

Also known as: PDT

Photodynamic therapy

Low level laser therapy RADIATION

λ = 660 ± 10 nm, P = 100 mW, PD = 510 mW/cm2, E = 4 J, ED = 20 J/cm2, t = 40 s, once a week for 4 weeks

Also known as: LLLT

Low level laser therapy

Eligibility Criteria

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

You may qualify if:

• adult female patients (aged over 18 years);
• vulvar lichen sclerosus diagnosed histologically;
• normal level of cortisol confirmed by blood test.

You may not qualify if:

• adult female patients under the age of 18;
• patients with any kind of ongoing cancer and/or AIDS or coagulopathy, pregnant or breastfeeding women;
• patients using corticosteroids, immunosuppressants or anticoagulants;
• patients with renal, hepatic or pulmonary-cardiovascular failure;
• patients who have undergone any kind of organ transplantation in the last three years.

Sponsors & Collaborators

• Daniela de Fátima Teixeira da Silva: lead
• Hospital Perola Byington: collaborator

Study Sites (1)

Hospital Pérola Byington

São Paulo, São Paulo, 01314000, Brazil

Location

Related Publications (22)

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  PMID: 28793884 DERIVED

MeSH Terms

Conditions

Vulvar Lichen Sclerosus

Interventions

Clobetasol; Adrenal Cortex Hormones; Photochemotherapy; 1-phenyl-3,3-dimethyltriazene; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Laser Therapy

Study Officials

• Daniela FT Silva, PhD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Postgraduate program in Biophotonics applied to HealthSciences

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: April 15, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

BR (1)