Vulvar Lichen SclerosusPhase 2NCT00757874
Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus
A Phase 2 study testing Tacrolimus cream and Clobetasol cream in people with Vulvar Lichen Sclerosus, run by Deana Funaro at 1 site in Canada.
Trial summary
Lichen Sclerosus is an inflammatory skin condition affecting mostly the genital area of persons of all ages, gender or race. The most frequent complaint is that of itchiness of the vulva but pain may also occur. Some women will experience no symptoms at all. Read more about this study
- Who is it for?
- Ages 2 years and older, women only
- Conditions the study is for
- Vulvar Lichen Sclerosus
- What is being tested?
- Tacrolimus cream and Clobetasol cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2006to Jan 2010
- Phase
- Phase 2
- 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 2 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female, 2 years or older
- Medical diagnosis of vulvar lichen sclerosus
- Received no treatment during the last 4 weeks
Who cannot join
- Who have received topical steroids, tacrolimus or pimecrolimus during the 4 last weeks.
- Who are immunocompromised
- Who have history of intra-epithelial neoplasia or anogenital carcinoma
- Who have active vulvar infections (herpes,condylomas,vaginitis)
- Who are hypersensitive to tacrolimus, pimecrolimus or corticosteroids
- Who have physical limitations that cause difficulty in applying the cream
- Who wear diapers
- Who present Hyperkeratotic Vulvar Lichen Sclerosus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind Phase II Study Comparing Safety and Efficacy of Tacrolimus Versus Topical Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus.
Lichen Sclerosus is an inflammatory skin condition affecting mostly the genital area of persons of all ages, gender or race. The most frequent complaint is that of itchiness of the vulva but pain may also occur. Some women will experience no symptoms at all. However, it is important to treat this condition since it may increase and cause important scarring and deformity. In less than 5% of cases, cancer may develop.
Lichen Sclerosus is a chronic disease which can be controlled but not cured. Topical corticosteroids are the usual treatment for this condition. Though this treatment is generally well tolerated, some patients may not present a sufficient response or may develop mainly local and rarely systemic side effects. In this perspective, an alternative treatment would be beneficial.
Read more
Tacrolimus, a topical immunomodulator has been approved for the treatment of atopic eczema and has shown its efficacy in the treatment of vulvar lichen sclerosus in a limited number of patients. Tacrolimus acts as a non-steroidal anti-inflammatory agent (NSAI) without causing the usual side effects seen with the prolonged use of topical corticosteroids.
This study is designed to evaluate the safety and efficacy of tacrolimus in treating vulvar lichen sclerosus by comparing it with the standard topical corticosteroid treatment.
- Conditions
- Vulvar Lichen Sclerosus
- Being tested
- Tacrolimus cream, Clobetasol cream
- Keywords
- Female urogenital disease, skin disease
- Medical subject headings
- Vulvar Lichen Sclerosus, Female Urogenital Diseases, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus creamDrug
Also called Prtopic
0.5 g per day at bed time for 3 months or less.
Clobetasol creamDrug
Also called Dermovate
0.5 gram each day at bed time during 3 months or less.
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus cream | Experimental | Not described Receives: Drug: Tacrolimus cream |
| Clobetasol cream | Active comparator | Not described Receives: Drug: Clobetasol cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
To document the efficacy of Tacrolimus vs topical clobetasol propionate in the treatment of Vulvar Lichen Sclerosus by medical examinations and reporting of the symptoms. Cream is applied once a day for 3 months
Measured: Comparison before the treatment and monthly for 3 months.
Secondary outcomes (2)
Compared presence and severity of side effects of both groups.
Measured: During the 3 months of treatment
CBC, Glycemia, vitamine B 12 dosage, TSH (to find associated auto-immune diseases)
Measured: At 1 to 3 months after starting the study, collected once.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startApr 2006
- Primary completionNov 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deana Funaro
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor-investigator, Deana Funaro, St. Justine's Hospital
- Investigators
- Deana Funaro, Doctor, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757874
- Sponsor's protocol ID
- StJustineH
- Status last verified
- Sep 2015
- First submitted
- 22 Sep 2008
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Phase II Study Comparing Safety and Efficacy of Tacrolimus Versus Topical Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus.
- ClinicalTrials.gov ID
- NCT00757874
- Acronym / sponsor ID
- StJustineH
- Conditions
- Vulvar Lichen Sclerosus
- Keywords
- Female urogenital disease, skin disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Deana FunaroUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- Apr 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 23 Sep 2008 (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 an inflammatory skin condition affecting mostly the genital area of persons of all ages, gender or race. The most frequent complaint is that of itchiness of the vulva but pain may also occur. Some women will experience no symptoms at all. However, it is important to treat this condition since it may increase and cause important scarring and deformity. In less than 5% of cases, cancer may develop.
Lichen Sclerosus is a chronic disease which can be controlled but not cured. Topical corticosteroids are the usual treatment for this condition. Though this treatment is generally well tolerated, some patients may not present a sufficient response or may develop mainly local and rarely systemic side effects. In this perspective, an alternative treatment would be beneficial.
Tacrolimus, a topical immunomodulator has been approved for the treatment of atopic eczema and has shown its efficacy in the treatment of vulvar lichen sclerosus in a limited number of patients. Tacrolimus acts as a non-steroidal anti-inflammatory agent (NSAI) without causing the usual side effects seen with the prolonged use of topical corticosteroids.
This study is designed to evaluate the safety and efficacy of tacrolimus in treating vulvar lichen sclerosus by comparing it with the standard topical corticosteroid treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus cream | Experimental | Drug: Tacrolimus cream |
| Clobetasol cream | Active comparator | Drug: Clobetasol cream |
Who may qualify
- Ages
- 2 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Female, 2 years or older
- Medical diagnosis of vulvar lichen sclerosus
- Received no treatment during the last 4 weeks
Key exclusion criteria (8 listed)
- Who have received topical steroids, tacrolimus or pimecrolimus during the 4 last weeks.
- Who are immunocompromised
- Who have history of intra-epithelial neoplasia or anogenital carcinoma
- Who have active vulvar infections (herpes,condylomas,vaginitis)
- Who are hypersensitive to tacrolimus, pimecrolimus or corticosteroids
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 |
|---|---|---|
| Tacrolimus creamAlso: Prtopic0.5 g per day at bed time for 3 months or less. | Drug | Tacrolimus cream |
| Clobetasol creamAlso: Dermovate0.5 gram each day at bed time during 3 months or less. | Drug | Clobetasol cream |
Primary outcome
To document the efficacy of Tacrolimus vs topical clobetasol propionate in the treatment of Vulvar Lichen Sclerosus by medical examinations and reporting of the symptoms. Cream is applied once a day for 3 months
Time frame: Comparison before the treatment and monthly for 3 months.
2 secondary outcomes
Compared presence and severity of side effects of both groups.
Time frame: During the 3 months of treatment
CBC, Glycemia, vitamine B 12 dosage, TSH (to find associated auto-immune diseases)
Time frame: At 1 to 3 months after starting the study, collected once.
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 9 Sep 2015.
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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.
Deana Funaro, Doctor principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tacrolimus cream and Clobetasol cream in people with Vulvar Lichen Sclerosus, run by Deana Funaro at 1 site in Canada.
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 8 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 9 Sep 2015. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To document the efficacy of Tacrolimus vs topical clobetasol propionate in the treatment of Vulvar Lichen Sclerosus by medical examinations and reporting of the symptoms. Cream is applied once a day for 3 months (time frame: Comparison before the treatment and monthly for 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2015.