Laser vs Clobetasol for Lichen Sclerosus

NCT05010421 | Completed Phase 3

• 1 other identifier: LASER-LICH1
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Lichen Sclerosus

Keywords

Lichen Sclerosus; Laser; Clobetasol; Corticosteroids

Outcome Measures

Primary Outcomes (1)

• 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.

  from date of randomization until 12 weeks

Secondary Outcomes (4)

• Efficacy - Physician-scored rate of visual improvement (0-10)

  3 months after treatment start

• Safety - Number and severity of side effects

  0-7 days after laser treatment (laser group); as well as throughout study duration (3 months; both groups)

• Subjective overall improvement (0-10)

  3 months after treatment start

• Vulval Disease Quality of life Index (0-45)

  Throughout study completion (3 months; for a total of 4 or 5 assessments, depending on group assignment)

Study Arms (2)

Clobetasol Group

ACTIVE COMPARATOR

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

Drug: Clobetasol 0.05% Emollient Top Cream

Laser Group

EXPERIMENTAL

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

Device: Non-ablative CO2 Laser

Interventions

Non-ablative CO2 Laser DEVICE

Superficial non-ablative laser treatment of affected vulvar skin areas.

Laser Group

Clobetasol 0.05% Emollient Top Cream DRUG

Topical corticosteroid treatment of affected vulvar skin areas.

Also known as: Dermoxin (Germany), Temovate, Clobex, Dermovate, Impoyz

Clobetasol Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Marien Hospital Herne

Herne, North Rhine-Westphalia, 44625, Germany

Location

Related Publications (6)

• 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.

  PMID: 30981618 BACKGROUND

• 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.

  PMID: 31729009 BACKGROUND

• Murphy R. Lichen sclerosus. Dermatol Clin. 2010 Oct;28(4):707-15. doi: 10.1016/j.det.2010.07.006.

  PMID: 20883914 BACKGROUND

• 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.

  PMID: 15210462 BACKGROUND

• 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.

  PMID: 22483994 BACKGROUND

• 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.

  PMID: 31934950 BACKGROUND

MeSH Terms

Conditions

Lichen Sclerosus et Atrophicus

Interventions

Clobetasol

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Clemens B Tempfer, MD

  Ruhr-Universität Bochum / Marien Hospital Herne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective randomized open single center study

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: August 18, 2021
• Study Start: November 2, 2021
• Primary Completion: July 10, 2025
• Study Completion: October 17, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After publication of the study results, no time limit.
• Access Criteria: Reasonable request, approval of the intended study by an independent review committee identified for this purpose.

Locations

DE (1)