Vulvar Lichen SclerosusVLSCBCPPTLILNCT02416531
Vulvar Lichen Sclerosus: Comparison Between Clobetasol Propionate, Photodynamic Therapy and Low-Intensity Laser
A study testing Clobetasol propionate, Photodynamic therapy and Low level laser therapy in people with Vulvar Lichen Sclerosus, run by Daniela de Fátima Teixeira da Silva at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Lichen Sclerosus
- What is being tested?
- Clobetasol propionate, Photodynamic therapy and Low level laser therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult female patients (aged over 18 years);
- vulvar lichen sclerosus diagnosed histologically;
- normal level of cortisol confirmed by blood test.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vulvar Lichen Sclerosus: Therapeutic Comparison Between Clobetasol Propionate, Photodynamic Therapy and Low-Intensity Laser
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.
Read the detailed description
Dosimetry and Experimental Groups: There is no dosimetric protocol established for the treatment of VLS with PDT, nor with LLLT. According to the literature, energy densities range from 9 to 150 J/cm2 and power densities from 40 to 700 mW/cm2, not to mention work that do not report the dosimetry used. As such, the dosimetry to be used in this study is based on a pilot clinical study performed by our group.
The patients will be randomized into 3 groups with 20 patients in each one:
Group GC: Corticosteroid over the whole vulva. Clobetasol propionate 0.05% ointment applied once daily at a dose of 1 g/application (1 g sachets) for 4 weeks.
Group GPDT: Localized photodynamic therapy at 8 points of the vulva. 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.
Group GLLLT: Localized low-level laser therapy at 8 points of the vulva. The same parameters as for GPDT, except for the methylene blue, once a week for 4 weeks.
Analyses: The histological and immunohistochemical analyses will be performed before and 30 days after the start of treatment, whereas clinical analysis will be performed weekly on treatment days for the GPDT and GLLLT groups. The control group will not be seen weekly because the standard treatment is performed by the patients themselves, in their own homes, for 30 days as recommended by the International Society for the Study of Vulvar Disease (ISSVD).
After treatments the patients will be followed for verification of recorrence during one year, at minimum.
- Conditions
- Vulvar Lichen Sclerosus
- Being tested
- Clobetasol propionate, Photodynamic therapy, Low level laser therapy
- Keywords
- Vulvar lichen sclerosus, Photodynamic therapy, Low-level laser therapy, Clobetasol propionate
- Medical subject headings
- Vulvar Lichen Sclerosus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clobetasol propionateDrug
Also called Corticosteroid
Clobetasol propionate 0.05% ointment applied once daily at a dose of 1 g/application (1 g sachets) for 4 weeks.
Photodynamic therapyRadiation
Also called PDT
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
Low level laser therapyRadiation
Also called LLLT
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
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid | Active comparator | Clobetasol propionate 0.05% ointment applied once daily at a dose of 1 g/application (1 g sachets) for 4 weeks. Receives: 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. Receives: 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. Receives: Radiation: Low level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Once deparaffinized, the tissue samples will be subjected to antigen retrieval, endogenous enzyme blocking, background blocking, incubations of antibodies, and counter-staining according to the instructions of the manufacturers. The cells that are positively stained by the immunohistochemical reaction will be counted with the aid of ImageJ software (National Institutes of Health, Maryland, USA) by two independent pathologists without prior knowledge of the experimental groups.
Measured: Participants will be followed for 1 month during VLS's treatment.
Percentage of relative reflectance as assessed by In-Vivo Reflectance Spectroscopy.
A portable spectrophotometer (400-900 nm) comprising a light source and a fiber-optic probe will be used directly on the surface of the vulvar skin in areas affected by VLS and in healthy areas of the same patients. Relative spectra will be obtained for the wavelengths corresponding to those of the therapeutic window, and the percentage of relative reflectance will be calculated.
Measured: Participants will be followed for 1 month during VLS's treatment.
Temperature, as assessed by infrared thermographic camera, in Celsius degrees.
Measurements will be recorded as images in all sessions before, during, and after irradiation to observe the thermal fluctuation in the procedures.
Measured: Participants will be followed for 1 month during VLS's treatment.
Itching, as assessed by Visual Analog Scale.
In each session, the patients will be asked about the intensity of vulvar itching to assess its severity and duration, before and after irradiation, according to a visual analog scale.
Measured: Participants will be followed for 1 month during VLS's treatment.
Clamping, as assessed by digital caliper, in mm.
The clamping of the lesion to monitor skin atrophy will be done before irradiation at each session, using a digital caliper, transversely and longitudinally in relation to the labia majora.
Measured: Participants will be followed for 1 month during VLS's treatment.
Area, as assessed by digital camera, in cm2.
The appearance and area of the lesion will be monitored with a digital camera at every session, before irradiation. To facilitate measurements, a metric scale will be rested on all vulvas for the photos. The areas of the lesions will be quantified using ImageJ software (National Institutes of Health, Maryland, USA).
Measured: Participants will be followed for 1 month during VLS's treatment.
Collagen birefringence, as assessed by polarized light microscope, in nm.
The correlation between birefringence and collagen ordering has been used since the 1960s. To the present date, polarized-light microscopy is an efficient method to quantify the change in collagen birefringence due to the effects of different agents. Since atrophy of the skin is a characteristic symptom of patients with VLS, the more detailed study of collagen fibers will elucidate the interaction of radiation with this type of tissue.
Measured: Participants will be followed for 1 month during VLS's treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2016
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Vulvar Lichen SclerosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniela de Fátima Teixeira da Silva
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Perola Byington
- Responsible party
- Sponsor-investigator, Daniela de Fátima Teixeira da Silva, University of Nove de Julho
- Investigators
- Daniela FT Silva, PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416531
- Sponsor's protocol ID
- Lichen-768168
- Acronym
- VLSCBCPPTLIL
- Status last verified
- Oct 2017
- First submitted
- 25 Mar 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kreuter A, Wischnewski J, Terras S, Altmeyer P, Stucker M, Gambichler T. Coexistence of lichen sclerosus and morphea: a retrospective analysis of 472 patients with localized scleroderma from a German tertiary referral center. J Am Acad Dermatol. 2012 Dec;67(6):1157-62. doi: 10.1016/j.jaad.2012.04.003. Epub 2012 Apr 24.
PubMed 22533994Oyama N, Chan I, Neill SM, Hamada T, South AP, Wessagowit V, Wojnarowska F, D'Cruz D, Hughes GJ, Black MM, McGrath JA. Autoantibodies to extracellular matrix protein 1 in lichen sclerosus. Lancet. 2003 Jul 12;362(9378):118-23. doi: 10.1016/S0140-6736(03)13863-9.
PubMed 12867112Gambichler T, Kammann S, Tigges C, Kobus S, Skrygan M, Meier JJ, Kohler CU, Scola N, Stucker M, Bechara FG, Altmeyer P, Kreuter A. Cell cycle regulation and proliferation in lichen sclerosus. Regul Pept. 2011 Apr 11;167(2-3):209-14. doi: 10.1016/j.regpep.2011.02.003. Epub 2011 Feb 15.
PubMed 21329728Terlou A, Santegoets LA, van der Meijden WI, Heijmans-Antonissen C, Swagemakers SM, van der Spek PJ, Ewing PC, van Beurden M, Helmerhorst TJ, Blok LJ. An autoimmune phenotype in vulvar lichen sclerosus and lichen planus: a Th1 response and high levels of microRNA-155. J Invest Dermatol. 2012 Mar;132(3 Pt 1):658-66. doi: 10.1038/jid.2011.369. Epub 2011 Nov 24.
PubMed 22113482Gambichler T, Terras S, Kreuter A, Skrygan M. Altered global methylation and hydroxymethylation status in vulvar lichen sclerosus: further support for epigenetic mechanisms. Br J Dermatol. 2014 Mar;170(3):687-93. doi: 10.1111/bjd.12702.
PubMed 24164308Perez-Lopez FR, Ceausu I, Depypere H, Erel CT, Lambrinoudaki I, Rees M, Schenck-Gustafsson K, Tremollieres F, van der Schouw YT, Simoncini T; EMAS, Spanish Menopause society. EMAS clinical guide: vulvar lichen sclerosus in peri and postmenopausal women. Maturitas. 2013 Mar;74(3):279-82. doi: 10.1016/j.maturitas.2012.12.006. Epub 2013 Jan 3.
PubMed 23291001Murphy R. Lichen sclerosus. Dermatol Clin. 2010 Oct;28(4):707-15. doi: 10.1016/j.det.2010.07.006.
PubMed 20883914Selim MA, Hoang MP. A histologic review of vulvar inflammatory dermatoses and intraepithelial neoplasm. Dermatol Clin. 2010 Oct;28(4):649-67. doi: 10.1016/j.det.2010.07.005. Epub 2010 Aug 30.
PubMed 20883910Monsalvez V, Rivera R, Vanaclocha F. [Lichen sclerosus]. Actas Dermosifiliogr. 2010 Jan-Feb;101(1):31-8. Spanish.
PubMed 20109390Brodrick B, Belkin ZR, Goldstein AT. Influence of treatments on prognosis for vulvar lichen sclerosus: facts and controversies. Clin Dermatol. 2013 Nov-Dec;31(6):780-6. doi: 10.1016/j.clindermatol.2013.05.017.
PubMed 24160287Hantschmann P, Sterzer S, Jeschke U, Friese K. P53 expression in vulvar carcinoma, vulvar intraepithelial neoplasia, squamous cell hyperplasia and lichen sclerosus. Anticancer Res. 2005 May-Jun;25(3A):1739-45.
PubMed 16033093Thorstensen KA, Birenbaum DL. Recognition and management of vulvar dermatologic conditions: lichen sclerosus, lichen planus, and lichen simplex chronicus. J Midwifery Womens Health. 2012 May-Jun;57(3):260-75. doi: 10.1111/j.1542-2011.2012.00175.x.
PubMed 22594865Lipkin D, Kwon Y. Therapies and nursing care of women with vulvar dermatologic disorders. J Obstet Gynecol Neonatal Nurs. 2014 Mar-Apr;43(2):246-52. doi: 10.1111/1552-6909.12286. Epub 2014 Feb 6.
PubMed 24502413Burrows LJ, Creasey A, Goldstein AT. The treatment of vulvar lichen sclerosus and female sexual dysfunction. J Sex Med. 2011 Jan;8(1):219-22. doi: 10.1111/j.1743-6109.2010.02077.x. Epub 2010 Oct 18.
PubMed 20955314Terras S, Gambichler T, Moritz RK, Stucker M, Kreuter A. UV-A1 phototherapy vs clobetasol propionate, 0.05%, in the treatment of vulvar lichen sclerosus: a randomized clinical trial. JAMA Dermatol. 2014 Jun;150(6):621-7. doi: 10.1001/jamadermatol.2013.7733.
PubMed 24696010
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vulvar Lichen Sclerosus: Therapeutic Comparison Between Clobetasol Propionate, Photodynamic Therapy and Low-Intensity Laser
- ClinicalTrials.gov ID
- NCT02416531
- Acronym / sponsor ID
- VLSCBCPPTLIL / Lichen-768168
- Conditions
- Vulvar Lichen Sclerosus
- Keywords
- Vulvar lichen sclerosus, Photodynamic therapy, Low-level laser therapy, Clobetasol propionate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Daniela de Fátima Teixeira da SilvaUniversity, hospital or other
- Collaborators
- Hospital Perola Byington
- Study start
- Jan 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dosimetry and Experimental Groups: There is no dosimetric protocol established for the treatment of VLS with PDT, nor with LLLT. According to the literature, energy densities range from 9 to 150 J/cm2 and power densities from 40 to 700 mW/cm2, not to mention work that do not report the dosimetry used. As such, the dosimetry to be used in this study is based on a pilot clinical study performed by our group.
The patients will be randomized into 3 groups with 20 patients in each one:
Group GC: Corticosteroid over the whole vulva. Clobetasol propionate 0.05% ointment applied once daily at a dose of 1 g/application (1 g sachets) for 4 weeks.
Group GPDT: Localized photodynamic therapy at 8 points of the vulva. 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.
Group GLLLT: Localized low-level laser therapy at 8 points of the vulva. The same parameters as for GPDT, except for the methylene blue, once a week for 4 weeks.
Analyses: The histological and immunohistochemical analyses will be performed before and 30 days after the start of treatment, whereas clinical analysis will be performed weekly on treatment days for the GPDT and GLLLT groups. The control group will not be seen weekly because the standard treatment is performed by the patients themselves, in their own homes, for 30 days as recommended by the International Society for the Study of Vulvar Disease (ISSVD).
After treatments the patients will be followed for verification of recorrence during one year, at minimum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid | Active comparator | Drug: Clobetasol propionateClobetasol propionate 0.05% ointment applied once daily at a dose of 1 g/application (1 g sachets) for 4 weeks. |
| Photodynamic therapy | Experimental | Radiation: Photodynamic therapyMethylene 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. |
| Low level laser therapy | Experimental | Radiation: Low level laser therapyλ = 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult female patients (aged over 18 years);
- vulvar lichen sclerosus diagnosed histologically;
- normal level of cortisol confirmed by blood test.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clobetasol propionateAlso: CorticosteroidClobetasol propionate 0.05% ointment applied once daily at a dose of 1 g/application (1 g sachets) for 4 weeks. | Drug | Corticosteroid |
| Photodynamic therapyAlso: PDTMethylene 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 therapyAlso: LLLTλ = 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 |
Primary outcome
Change from baseline in biopsies at 1 month.
Time frame: Participants will be followed for 1 month during VLS's treatment.
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.
7 secondary outcomes
Count cells per mm2 by immunohistochemical reaction of IFN-γ, TGF-β, CD4, CD8, IL-1, p53 and Ki-67.
Time frame: Participants will be followed for 1 month during VLS's treatment.
Percentage of relative reflectance as assessed by In-Vivo Reflectance Spectroscopy.
Time frame: Participants will be followed for 1 month during VLS's treatment.
Temperature, as assessed by infrared thermographic camera, in Celsius degrees.
Time frame: Participants will be followed for 1 month during VLS's treatment.
Itching, as assessed by Visual Analog Scale.
Time frame: Participants will be followed for 1 month during VLS's treatment.
Clamping, as assessed by digital caliper, in mm.
Time frame: Participants will be followed for 1 month during VLS's treatment.
Area, as assessed by digital camera, in cm2.
Time frame: Participants will be followed for 1 month during VLS's treatment.
Collagen birefringence, as assessed by polarized light microscope, in nm.
Time frame: Participants will be followed for 1 month during VLS's treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Background: PubMed 22533994Kreuter A, Wischnewski J, Terras S, Altmeyer P, Stucker M, Gambichler T. Coexistence of lichen sclerosus and morphea: a retrospective analysis of 472 patients with localized scleroderma from a German tertiary referral center. J Am Acad Dermatol. 2012 Dec;67(6):1157-62. doi: 10.1016/j.jaad.2012.04.003. Epub 2012 Apr 24.
- Background: PubMed 12867112Oyama N, Chan I, Neill SM, Hamada T, South AP, Wessagowit V, Wojnarowska F, D'Cruz D, Hughes GJ, Black MM, McGrath JA. Autoantibodies to extracellular matrix protein 1 in lichen sclerosus. Lancet. 2003 Jul 12;362(9378):118-23. doi: 10.1016/S0140-6736(03)13863-9.
- Background: PubMed 21329728Gambichler T, Kammann S, Tigges C, Kobus S, Skrygan M, Meier JJ, Kohler CU, Scola N, Stucker M, Bechara FG, Altmeyer P, Kreuter A. Cell cycle regulation and proliferation in lichen sclerosus. Regul Pept. 2011 Apr 11;167(2-3):209-14. doi: 10.1016/j.regpep.2011.02.003. Epub 2011 Feb 15.
- Background: PubMed 22113482Terlou A, Santegoets LA, van der Meijden WI, Heijmans-Antonissen C, Swagemakers SM, van der Spek PJ, Ewing PC, van Beurden M, Helmerhorst TJ, Blok LJ. An autoimmune phenotype in vulvar lichen sclerosus and lichen planus: a Th1 response and high levels of microRNA-155. J Invest Dermatol. 2012 Mar;132(3 Pt 1):658-66. doi: 10.1038/jid.2011.369. Epub 2011 Nov 24.
- Background: PubMed 24164308Gambichler T, Terras S, Kreuter A, Skrygan M. Altered global methylation and hydroxymethylation status in vulvar lichen sclerosus: further support for epigenetic mechanisms. Br J Dermatol. 2014 Mar;170(3):687-93. doi: 10.1111/bjd.12702.
- Background: PubMed 23291001Perez-Lopez FR, Ceausu I, Depypere H, Erel CT, Lambrinoudaki I, Rees M, Schenck-Gustafsson K, Tremollieres F, van der Schouw YT, Simoncini T; EMAS, Spanish Menopause society. EMAS clinical guide: vulvar lichen sclerosus in peri and postmenopausal women. Maturitas. 2013 Mar;74(3):279-82. doi: 10.1016/j.maturitas.2012.12.006. Epub 2013 Jan 3.
- Background: PubMed 20883914Murphy R. Lichen sclerosus. Dermatol Clin. 2010 Oct;28(4):707-15. doi: 10.1016/j.det.2010.07.006.
- Background: PubMed 20883910Selim MA, Hoang MP. A histologic review of vulvar inflammatory dermatoses and intraepithelial neoplasm. Dermatol Clin. 2010 Oct;28(4):649-67. doi: 10.1016/j.det.2010.07.005. Epub 2010 Aug 30.
- Background: PubMed 20109390Monsalvez V, Rivera R, Vanaclocha F. [Lichen sclerosus]. Actas Dermosifiliogr. 2010 Jan-Feb;101(1):31-8. Spanish.
- Background: PubMed 24160287Brodrick B, Belkin ZR, Goldstein AT. Influence of treatments on prognosis for vulvar lichen sclerosus: facts and controversies. Clin Dermatol. 2013 Nov-Dec;31(6):780-6. doi: 10.1016/j.clindermatol.2013.05.017.
- Background: PubMed 16033093Hantschmann P, Sterzer S, Jeschke U, Friese K. P53 expression in vulvar carcinoma, vulvar intraepithelial neoplasia, squamous cell hyperplasia and lichen sclerosus. Anticancer Res. 2005 May-Jun;25(3A):1739-45.
- Background: PubMed 22594865Thorstensen KA, Birenbaum DL. Recognition and management of vulvar dermatologic conditions: lichen sclerosus, lichen planus, and lichen simplex chronicus. J Midwifery Womens Health. 2012 May-Jun;57(3):260-75. doi: 10.1111/j.1542-2011.2012.00175.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela FT Silva, PhD principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clobetasol propionate, Photodynamic therapy and Low level laser therapy in people with Vulvar Lichen Sclerosus, run by Daniela de Fátima Teixeira da Silva at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in biopsies at 1 month. (time frame: Participants will be followed for 1 month during VLS's treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02416531, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.