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Laser vs Clobetasol for Lichen Sclerosus

Primary Purpose

Lichen Sclerosus

Status
Recruiting
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Clobetasol 0.05% Emollient Top Cream
Non-ablative CO2 Laser
Sponsored by
Ruhr University of Bochum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lichen Sclerosus focused on measuring Lichen Sclerosus, Laser, Clobetasol, Corticosteroids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women, age ≥ 18 years
  • Established diagnosis of LS (vulva and/or perineum and/or perianal region)
  • Willingness to comply with study requirements
  • No significant language barrier

Exclusion Criteria:

  • Concurrent immunosuppressive treatment
  • A history of vulvar cancer and/or vulvar dysplasia
  • A history of vulvar surgery
  • A contraindication against clobetasol treatment
  • A known sun light allergy
  • A known skin condition interfering with local ablative treatment such as neurodermatitis or bullous pemphigoid

Sites / Locations

  • Marien Hospital HerneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Clobetasol Group

Laser Group

Arm Description

Treatment with clobetasol-0,05% over 3 months (month 1: daily, month 2: every other day, month 3: 3x per week)

3 applications every 14 days of a non-ablative CO2 laser treatment

Outcomes

Primary Outcome Measures

Vulvar burning, itching, and pain
Summary score of three symptoms of LS, i.e. vulvar burning, itching, and pain (11-item VAS each). Higher values mean worse outcome.

Secondary Outcome Measures

Efficacy - Physician-scored rate of visual improvement (0-10)
11-item VAS; higher values mean better outcome.
Safety - Number and severity of side effects
Side effects (perioperative and postoperative complications up to 7 days) including but not limited to bleeding, infection, wound breakdown, unscheduled re-admission, and local pain necessitating systemic analgesia.
Subjective overall improvement (0-10)
The patient's subjective judgement of improvement (11-item VAS); higher values mean better outcome.
Vulval Disease Quality of life Index (0-45)
Quality of life assessed before the start of therapy, after every treatment course (laser group; days 0, 14, 28, 42) or after 2 and 6 weeks (clobetasol group; days 0, 14, 42), and after 3 months (both groups) using a standardized, validated questionnaire (VDQI, Vulval Disease Quality of life Index). Lower score mean better outcome.

Full Information

First Posted
July 16, 2021
Last Updated
August 19, 2022
Sponsor
Ruhr University of Bochum
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1. Study Identification

Unique Protocol Identification Number
NCT05010421
Brief Title
Laser vs Clobetasol for Lichen Sclerosus
Official Title
CO2 Non-ablative Laser Versus Topical Clobetasol for Lichen Sclerosus: a Prospective, Open-label, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Lichen sclerosus (LS) is a common autoimmune disease of the genital skin. It affects 1/900 women with an age peak in the sixth decade of life and is manifested by chronic inflammation of the genital, perineal, and perianal areas associated with itching, burning, pain, and soreness. In addition, LS is associated with an increased risk of vulvar cancer. Treatment options for LS include topical steroids such as clobetasol, immunomodulators such as tacrolimus, and non-ablative laser treatment. Although both treatments are well documented and used in clinical practice, direct comparative studies of the efficacy of topical corticosteroids versus laser treatment in women with LS are rare. For example, a PubMed literature search (search date 2021-03-14; search terms: lichen sclerosus, laser, corticosteroids, steroids, clobetasol, randomized) identified only a single randomized trial with limited power. Given the available evidence, further high-quality studies are needed to define the superiority/inferiority of the different available treatment options such as nonablative lasers and topical corticosteroids. Therefore, in this prospective, randomized, open-label, comparative study, treatment success after 3 courses of non-ablative treatment with CO2 laser every 14 days will be compared with treatment success after topical application of clobetasol 0.05% over 3 months (daily in the first month, every other day in month 2, and 3 times/week during month 3) at the time point 3 months after treatment initiation.
Detailed Description
Lichen sclerosus (LS) is a common autoimmune disorder of the genital skin. It affects 1/900 women with an age peak in the sixth decade of life. LS is a chronic inflammatory condition affecting the genital, perineal, and perianal areas and causes itching, burning, pain, and soreness. Histologically, LS is characterized by epidermal atrophy, hyperkeratosis, follicular plugging, degeneration of the basal layer, and subepidermal hyalinization of collagen in the papillary dermis with a lymphocytic infiltrate. Affected women typically suffer significant long-term genital damage including scarring, fusion of the vulval labia, narrowing of the vaginal opening, dyspareunia, and burying of the clitoris. In addition, LS is associated with an increased risk of vulvar cancer. Treatment options of LS include topical steroids such as clobetasol, topical immunomodulators such as tacrolimus, and non-ablative laser treatment. In a systematic review of the literature with 7 studies and 249 participants, clobetasol achieved improvement rates and remission rates of 70% to 89% and 20% to 35%, respectively. In comparison, non-ablative laser treatment leads to significant improvements in vulvar itching, dryness, pain, and dyspareunia in 50% to 85% of women with remission rates of up to 80% after 14 years of follow-up. Although both treatments are well documented and used in clinical practice, direct comparative studies assessing the efficacy of topical corticosteroids versus laser treatment in women with LS are rare. For example, in a PubMed literature search (search date 2021-03-14; search terms: lichen sclerosus, laser, corticosteroids, steroids, clobetasol, randomized) only one randomized trial was identified. In this study, the authors included 40 women with LS and compared 3 applications of non-ablative laser 2 weeks apart with 4 weeks of twice daily (2 weeks), once daily (1 week), and every other day (1 week) of topical clobetasol 0.05% cream. After 3 months of treatment laser-treated women had a significantly higher sum score (including burning, itching, and pain) measured on an 11-step visual analogue scale (VAS). Both treatments demonstrated histological improvement with reductions of inflammatory hallmarks in skin biopsies. Given this body of evidence, more high-quality studies are needed to define the superiority/inferiority of the different available treatment options such as non-ablative laser and topical corticosteroids. Therefore, a prospective, randomized trial comparing non-ablative CO2 laser treatment and topical clobetasol 0.05% will be conducted. The aim of this prospective, randomized, open-label, comparative trial is to establish or refute the superiority of 3 courses of non-ablative treatment by CO2 laser every 14 days compared to topical clobetasol 0.05% (daily in month 1, every other day in month 2, and 3 times/week in month 3) for 3 months. The primary endpoint of this study is a sum score including the pathognomonic symptoms of LS, namely vulvar burning, itching, and pain, each measured on an 11-step VAS. Secondary endpoints will include the physician-scored rate of visual improvement (measured on an 11-item VAS), side effects, and patient-reported outcomes such as subjective overall improvement, general satisfaction, and quality of life (measured by a validated questionnaire for vulval disorders; i.e. the VDQI (Vulval Disease Quality of Life Index).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lichen Sclerosus
Keywords
Lichen Sclerosus, Laser, Clobetasol, Corticosteroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized open single center study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clobetasol Group
Arm Type
Active Comparator
Arm Description
Treatment with clobetasol-0,05% over 3 months (month 1: daily, month 2: every other day, month 3: 3x per week)
Arm Title
Laser Group
Arm Type
Experimental
Arm Description
3 applications every 14 days of a non-ablative CO2 laser treatment
Intervention Type
Drug
Intervention Name(s)
Clobetasol 0.05% Emollient Top Cream
Other Intervention Name(s)
Dermoxin (Germany), Temovate, Clobex, Dermovate, Impoyz
Intervention Description
Topical corticosteroid treatment of affected vulvar skin areas.
Intervention Type
Device
Intervention Name(s)
Non-ablative CO2 Laser
Intervention Description
Superficial non-ablative laser treatment of affected vulvar skin areas.
Primary Outcome Measure Information:
Title
Vulvar burning, itching, and pain
Description
Summary score of three symptoms of LS, i.e. vulvar burning, itching, and pain (11-item VAS each). Higher values mean worse outcome.
Time Frame
from date of randomization until 12 weeks
Secondary Outcome Measure Information:
Title
Efficacy - Physician-scored rate of visual improvement (0-10)
Description
11-item VAS; higher values mean better outcome.
Time Frame
3 months after treatment start
Title
Safety - Number and severity of side effects
Description
Side effects (perioperative and postoperative complications up to 7 days) including but not limited to bleeding, infection, wound breakdown, unscheduled re-admission, and local pain necessitating systemic analgesia.
Time Frame
0-7 days after laser treatment (laser group); as well as throughout study duration (3 months; both groups)
Title
Subjective overall improvement (0-10)
Description
The patient's subjective judgement of improvement (11-item VAS); higher values mean better outcome.
Time Frame
3 months after treatment start
Title
Vulval Disease Quality of life Index (0-45)
Description
Quality of life assessed before the start of therapy, after every treatment course (laser group; days 0, 14, 28, 42) or after 2 and 6 weeks (clobetasol group; days 0, 14, 42), and after 3 months (both groups) using a standardized, validated questionnaire (VDQI, Vulval Disease Quality of life Index). Lower score mean better outcome.
Time Frame
Throughout study completion (3 months; for a total of 4 or 5 assessments, depending on group assignment)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women, age ≥ 18 years Established diagnosis of LS (vulva and/or perineum and/or perianal region) Willingness to comply with study requirements No significant language barrier Exclusion Criteria: Concurrent immunosuppressive treatment A history of vulvar cancer and/or vulvar dysplasia A history of vulvar surgery A contraindication against clobetasol treatment A known sun light allergy A known skin condition interfering with local ablative treatment such as neurodermatitis or bullous pemphigoid
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clemens B Tempfer, MD
Phone
+492323499
Ext
1801
Email
clemens.tempfer@rub.de
First Name & Middle Initial & Last Name or Official Title & Degree
Günther A Rezniczek, PhD
Phone
+492323499
Ext
1058
Email
guenther.rezniczek@rub.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clemens B Tempfer, MD
Organizational Affiliation
Ruhr-Universität Bochum / Marien Hospital Herne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marien Hospital Herne
City
Herne
State/Province
NRW
ZIP/Postal Code
44625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clemens B Tempfer, MD, MBA

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared upon reasonable request made to the corresponding author. This includes individual participant data underlying the results presented here, after deidentification, as well as data dictionaries and the the study protocol. Data is available after publication, without a specific end date. Requesting investigators must show that their proposed use of the data has been approved by an independent review committee identified for this purpose.
IPD Sharing Time Frame
After publication of the study results, no time limit.
IPD Sharing Access Criteria
Reasonable request, approval of the intended study by an independent review committee identified for this purpose.
Citations:
PubMed Identifier
30981618
Citation
Bizjak Ogrinc U, Sencar S, Luzar B, Lukanovic A. Efficacy of Non-ablative Laser Therapy for Lichen Sclerosus: A Randomized Controlled Trial. J Obstet Gynaecol Can. 2019 Dec;41(12):1717-1725. doi: 10.1016/j.jogc.2019.01.023. Epub 2019 Apr 11.
Results Reference
background
PubMed Identifier
31729009
Citation
Felmingham C, Chan L, Doyle LW, Veysey E. The Vulval Disease Quality of Life Index in women with vulval lichen sclerosus correlates with clinician and symptom scores. Australas J Dermatol. 2020 May;61(2):110-118. doi: 10.1111/ajd.13197. Epub 2019 Nov 14.
Results Reference
background
PubMed Identifier
20883914
Citation
Murphy R. Lichen sclerosus. Dermatol Clin. 2010 Oct;28(4):707-15. doi: 10.1016/j.det.2010.07.006.
Results Reference
background
PubMed Identifier
15210462
Citation
Renaud-Vilmer C, Cavelier-Balloy B, Porcher R, Dubertret L. Vulvar lichen sclerosus: effect of long-term topical application of a potent steroid on the course of the disease. Arch Dermatol. 2004 Jun;140(6):709-12. doi: 10.1001/archderm.140.6.709.
Results Reference
background
PubMed Identifier
22483994
Citation
Chi CC, Kirtschig G, Baldo M, Lewis F, Wang SH, Wojnarowska F. Systematic review and meta-analysis of randomized controlled trials on topical interventions for genital lichen sclerosus. J Am Acad Dermatol. 2012 Aug;67(2):305-12. doi: 10.1016/j.jaad.2012.02.044. Epub 2012 Apr 6.
Results Reference
background
PubMed Identifier
31934950
Citation
Pagano T, Conforti A, Buonfantino C, Schettini F, Vallone R, Gallo A, Avino L, Alviggi C, De Placido G, Sopracordevole F. Effect of rescue fractional microablative CO2 laser on symptoms and sexual dysfunction in women affected by vulvar lichen sclerosus resistant to long-term use of topic corticosteroid: a prospective longitudinal study. Menopause. 2020 Apr;27(4):418-422. doi: 10.1097/GME.0000000000001482.
Results Reference
background

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Laser vs Clobetasol for Lichen Sclerosus

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