Vulvar Lichen SclerosusNCT01400022
Topical 0.05% Clobetasol Propionate in Vaseline Versus UVA-1 Phototherapy in Vulvar Lichen Sclerosus
A study testing UVA1 phototherapy and Cortisone in people with Vulvar Lichen Sclerosus, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
Lichen sclerosus is a rare, chronic cutaneous disorder with a predilection for the genital area. Any age group may be affected, although it is seen more often in postmenopausal women. The current gold standard treatment is topical ultrapotent corticosteroids such as clobetasol. 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?
- UVA1 phototherapy and Cortisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2010to Feb 2013
- 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
- patients with genital lichen sclerosus
- Age > 18 years
- Willingness to participate in this study
- No topical steroids within the last 4 weeks
Who cannot join
- Age < 18 years
- Known photodermatosis (eg, solar urticaria, polymorphous light eruption)
- Known genodermatosis with UV-sensitivity
- Treatment with photosensitizing drugs
- History of skin cancer
- significant UV exposure 3 months before study entry
- application of UV radiation therapies outside of the study conducted by UV irradiation: as: PUVA, UVA (including UVA1), UVB (including SEA) in the last 4 weeks before study entry or during the study period
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Dermatology, Ruhr University Bochum
Bochum, North Rhine-Westphalia, 44791
About this study
Official title: A Randomized Clinical Study Comparing Topical 0.05% Clobetasol Propianate in Vaseline With UVA-1 Phototherapy in the Treatment of Vulvar Lichen Sclerosus
Lichen sclerosus is a rare, chronic cutaneous disorder with a predilection for the genital area. Any age group may be affected, although it is seen more often in postmenopausal women. The current gold standard treatment is topical ultrapotent corticosteroids such as clobetasol.
Here we compare UVA1 phototherapy with 0,05% clobetasol propionate in vaseline for the treatment of vulvar lichen sclerosus.
Read the detailed description
Genital lichen sclerosus is a rare chronic inflammatory connective tissue disease. The association with other autoimmune diseases and the detection of autoantibodies against ECM-1 point to an autoimmune genesis. Genital lichen sclerosus typically affects women around and after the menopause. Common sites of affection are the vulva (clitoris and labia majora) and the anus in women, the prepuce and the glans penis in men. Skin lesions include ivory-white, atrophic, porcelain-like plaques with a tendency to atrophy and fissures in the advanced stages.
First-line therapy for genital lichen sclerosus in the active, inflammatory phase is the use of topical glucocorticoids. Alternatively, topically applied hormone-containing emollients and topical calcineurin inhibitors are widely used. However, the use of topical corticosteroids is because of the associated long-term side effects (atrophy, striae) limited.
In the treatment of localized scleroderma (morphea), a similar sclerosing disease, the use of ultraviolet radiation (UVA1) has proved highly effective. After a pilot study, the high-dose UVA1 phototherapy (120 J / cm ²) was significantly more effective was a low-dose UVA1 (20 J / cm ²), however no difference could be found in subsequent studies. Meanwhile, the medium-dose UVA1 phototherapy in circumscribed scleroderma has been determined as the most effective therapy regime and is included in the german dermatological guidelines (see also AWMF guideline for diagnosis and therapy of circumscribed scleroderma at: http://www.uni-duesseldorf.de/awmf/ll/013- 066.htm).
- Conditions
- Vulvar Lichen Sclerosus
- Being tested
- UVA1 phototherapy, Cortisone
- Keywords
- lichen, sclerosus, genital, vulvar, UVA1
- 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.
UVA1 phototherapyOther
The UVA1-phototherapy is conducted 4 times per week over a period of 3 months. A UVA1-irradiation device of the company Sellamed, Gevelsberg (Germany) is used. The radiation intensity is 24 mW/cm ². The distance between radiation source and irradiation area is approximately 25 cm. Over five sessions, the UVA1 dose is increased slowly, starting with 10 J/cm ² in the first, 20 J/cm ² in the second and 30 J/cm ² in the third, 40 J/cm ² in the fourth, and from the fifth session 50 J/cm ². Additionally, a topical treatment with vaseline album once daily can be applied after irradiation (not before irradiation).
CortisoneOther
Clobetasol propionate (0.05%) in white vaseline is applied thinly once daily. The duration of treatment is 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Cortisone | Active comparator | Not described Receives: Other: Cortisone |
| UVA1 phototherapy | Experimental | Not described Receives: Other: UVA1 phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement during UVA1/cortisone treatment
Clinical improvement during UVA1/cortisone treatment using an investigator score measuring hypopigmentation, sclerosis, atrophy, hyperkeratosis, erosions, edema, erythema in a numerical scale as to be rated followed: 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The total score is then calculated respectively from the sum of individual scores (max. 21 points).
Measured: 6 months follow-up
Secondary outcomes (5)
subjective patient score
a subjective patient-score to measure burning, pain and itch using a visual analogue scale with score from 0 (absent) to 10 (most severe imaginable)
Measured: until 6 months follow-up
Influence on Quality of Life
Measuring the influence of the disease on the Quality of Life using a qualified Questionnaire on Quality of Life in Dermatology: Skindex-29
Measured: until 6 months follow-up
Colorimetry
Objective measurement of colour to determine erythema, severity of white patches.
Measured: baseline and after 3 months of treatment
Ultrasound to determine the severity of the sclerosis
A 22MHz Ultrasound of the involved area is performed at the baseline and after 3 months of therapy to determine the severity of the sclerosis
Measured: baseline and after 3 months of treatment
Immunological, RT-PCR and histological parameters in skin biopsies
Measuring several immunohistochemical, RT-PCR and serological parameters in skin and blood, respectively.
Measured: baseline and after 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startAug 2010
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AKreuter, Ruhr University of Bochum
- Investigators
- Alexander Kreuter, MD, Prof., Principal investigator, Ruhr University BochumSarah Terras, MD, Principal investigator, Ruhr University BochumThilo Gambichler, MD, Principal investigator, Ruhr University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400022
- Sponsor's protocol ID
- RUB-125
- Status last verified
- May 2013
- First submitted
- 21 Jul 2011
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Terras 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 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Study Comparing Topical 0.05% Clobetasol Propianate in Vaseline With UVA-1 Phototherapy in the Treatment of Vulvar Lichen Sclerosus
- ClinicalTrials.gov ID
- NCT01400022
- Acronym / sponsor ID
- RUB-125
- Conditions
- Vulvar Lichen Sclerosus
- Keywords
- lichen, sclerosus, genital, vulvar, UVA1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 22 Jul 2011 (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.
Lichen sclerosus is a rare, chronic cutaneous disorder with a predilection for the genital area. Any age group may be affected, although it is seen more often in postmenopausal women. The current gold standard treatment is topical ultrapotent corticosteroids such as clobetasol.
Here we compare UVA1 phototherapy with 0,05% clobetasol propionate in vaseline for the treatment of vulvar lichen sclerosus.
Detailed description
Genital lichen sclerosus is a rare chronic inflammatory connective tissue disease. The association with other autoimmune diseases and the detection of autoantibodies against ECM-1 point to an autoimmune genesis. Genital lichen sclerosus typically affects women around and after the menopause. Common sites of affection are the vulva (clitoris and labia majora) and the anus in women, the prepuce and the glans penis in men. Skin lesions include ivory-white, atrophic, porcelain-like plaques with a tendency to atrophy and fissures in the advanced stages.
First-line therapy for genital lichen sclerosus in the active, inflammatory phase is the use of topical glucocorticoids. Alternatively, topically applied hormone-containing emollients and topical calcineurin inhibitors are widely used. However, the use of topical corticosteroids is because of the associated long-term side effects (atrophy, striae) limited.
In the treatment of localized scleroderma (morphea), a similar sclerosing disease, the use of ultraviolet radiation (UVA1) has proved highly effective. After a pilot study, the high-dose UVA1 phototherapy (120 J / cm ²) was significantly more effective was a low-dose UVA1 (20 J / cm ²), however no difference could be found in subsequent studies. Meanwhile, the medium-dose UVA1 phototherapy in circumscribed scleroderma has been determined as the most effective therapy regime and is included in the german dermatological guidelines (see also AWMF guideline for diagnosis and therapy of circumscribed scleroderma at: http://www.uni-duesseldorf.de/awmf/ll/013- 066.htm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cortisone | Active comparator | Other: Cortisone |
| UVA1 phototherapy | Experimental | Other: UVA1 phototherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with genital lichen sclerosus
- Age > 18 years
- Willingness to participate in this study
- No topical steroids within the last 4 weeks
Key exclusion criteria (7 listed)
- Age < 18 years
- Known photodermatosis (eg, solar urticaria, polymorphous light eruption)
- Known genodermatosis with UV-sensitivity
- Treatment with photosensitizing drugs
- History of skin cancer
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 |
|---|---|---|
| UVA1 phototherapyThe UVA1-phototherapy is conducted 4 times per week over a period of 3 months. A UVA1-irradiation device of the company Sellamed, Gevelsberg (Germany) is used. The radiation intensity is 24 mW/cm ². The distance between radiation source and irradiation area is approximately 25 cm. Over five sessions, the UVA1 dose is increased slowly, starting with 10 J/cm ² in the first, 20 J/cm ² in the second and 30 J/cm ² in the third, 40 J/cm ² in the fourth, and from the fifth session 50 J/cm ². Additionally, a topical treatment with vaseline album once daily can be applied after irradiation (not before irradiation). | Other | UVA1 phototherapy |
| CortisoneClobetasol propionate (0.05%) in white vaseline is applied thinly once daily. The duration of treatment is 3 months. | Other | Cortisone |
Primary outcome
Clinical improvement during UVA1/cortisone treatment
Time frame: 6 months follow-up
Clinical improvement during UVA1/cortisone treatment using an investigator score measuring hypopigmentation, sclerosis, atrophy, hyperkeratosis, erosions, edema, erythema in a numerical scale as to be rated followed: 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The total score is then calculated respectively from the sum of individual scores (max. 21 points).
5 secondary outcomes
subjective patient score
Time frame: until 6 months follow-up
Influence on Quality of Life
Time frame: until 6 months follow-up
Colorimetry
Time frame: baseline and after 3 months of treatment
Ultrasound to determine the severity of the sclerosis
Time frame: baseline and after 3 months of treatment
Immunological, RT-PCR and histological parameters in skin biopsies
Time frame: baseline and after 3 months of 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 30 May 2013.
- Derived from this study: PubMed 24696010Terras 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.
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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.
Alexander Kreuter, MD, Prof. principal investigator
Ruhr University Bochum
Sarah Terras, MD principal investigator
Ruhr University Bochum
Thilo Gambichler, MD principal investigator
Ruhr University Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UVA1 phototherapy and Cortisone in people with Vulvar Lichen Sclerosus, run by Ruhr University of Bochum at 1 site in Germany.
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 4 inclusion and 7 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 30 May 2013. 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 Germany. 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?
Clinical improvement during UVA1/cortisone treatment (time frame: 6 months follow-up). 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 NCT01400022, which also lists 1 linked publication.
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 30 May 2013.