Lichen SclerosusNCT02880904
Vulvar Scarring Grading Scale for Lichen Sclerosus
An observational study of Lichen Sclerosus and Lichen Sclerosus et Atrophicus, run by Northwestern University at 1 site in United States.
Trial summary
The study aims to validate a vulvar scarring grading scale for lichen sclerosus (LS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lichen Sclerosus, Lichen Sclerosus et Atrophicus
- What is being tested?
- Photography
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 10 Jan 2020
- Phase
- Observational
- 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
Study population: Female subjects from the Northwestern University Vulvar Mucosal Specialty Clinic, with histologically confirmed diagnosis of vulvar lichen sclerosus
Who may be able to join
- Patients seen at Northwestern Medicine Department of Dermatology and/or Department of Obstetrics and Gynecology, who were seen by Dr. Bethanee Schlosser, and/or other members of the Vulvar Mucosal Specialty Clinic team in any of their respective clinic settings and underwent complete mucocutaneous examination.
- Patients with histologically confirmed vulvar LS.
Who cannot join
- Patients who refuse complete mucocutaneous examination.
- Patients who refuse recommended diagnostic procedures.
- Pregnant women or prisoners.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: Development of a Vulvar Scarring Grading Scale for Lichen Sclerosus
The study aims to validate a vulvar scarring grading scale for lichen sclerosus (LS).
Read the detailed description
Utilizing the vulvar disorders registry, protocol #STU00001056, the research team seeks to analyze the medical record data, including standard of care vulvar photographs, of the vulvar LS population at Northwestern Memorial Hospital (NMH) and the outpatient clinics of Northwestern Medicine (NM). These photographs will be used to develop a vulvar scarring grading scale for LS. The objective measurement of scarring severity in LS deidentified standard-of-care patient photographs will be correlated with clinical examination findings to assess validity of the grading scale. The development of an objective and standardized grading scale will assist with the longitudinal evaluation of individual disease, assessment of impact of therapy on scarring, and inform treatment modifications. Further, objective grading of scarring would also provide the opportunity to search for potential correlation between QoL scores and severity of clinical states in scarring dermatoses.
- Conditions
- Lichen Sclerosus, Lichen Sclerosus et Atrophicus
- Being tested
- Photography
- Medical subject headings
- Lichen Sclerosus et Atrophicus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotographyOther
Photos will be taken of the vulvar lichen sclerosus lesions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Scarring severity grading scale for vulvar lichen sclerosus
Measured: one year
Secondary outcomes (1)
Correlation of severity of vulvar LS scarring, as documented at time of clinical examination and compared to scores on the LS grading scale, with the patient quality of life at the time of examination.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startMar 2016
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Why it stopped: Investigator is no longer at Northwestern University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lichen SclerosusStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Rangel, Northwestern University
- Investigators
- Bethanee J Schlosser, MD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880904
- Sponsor's protocol ID
- STU00202270
- Status last verified
- Oct 2020
- First submitted
- 4 May 2016
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hansen A, Carr K, Jensen JT. Characteristics and initial diagnoses in women presenting to a referral center for vulvovaginal disorders in 1996-2000. J Reprod Med. 2002 Oct;47(10):854-60.
PubMed 12418071Gokdemir G, Baksu B, Baksu A, Davas I, Koslu A. Features of patients with vulvar dermatoses in dermatologic and gynecologic practice in Turkey: is there a need for an interdisciplinary approach? J Obstet Gynaecol Res. 2005 Oct;31(5):427-31. doi: 10.1111/j.1447-0756.2005.00314.x.
PubMed 16176512McPherson T, Cooper S. Vulval lichen sclerosus and lichen planus. Dermatol Ther. 2010 Sep-Oct;23(5):523-32. doi: 10.1111/j.1529-8019.2010.01355.x.
PubMed 20868406Goldstein AT, Marinoff SC, Christopher K, Srodon M. Prevalence of vulvar lichen sclerosus in a general gynecology practice. J Reprod Med. 2005 Jul;50(7):477-80.
PubMed 16130842Schlosser BJ, Mirowski GW. Lichen sclerosus and lichen planus in women and girls. Clin Obstet Gynecol. 2015 Mar;58(1):125-42. doi: 10.1097/GRF.0000000000000090.
PubMed 25608255Bradford J, Fischer G. Long-term management of vulval lichen sclerosus in adult women. Aust N Z J Obstet Gynaecol. 2010 Apr;50(2):148-52. doi: 10.1111/j.1479-828X.2010.01142.x.
PubMed 20522071
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Vulvar Scarring Grading Scale for Lichen Sclerosus
- ClinicalTrials.gov ID
- NCT02880904
- Acronym / sponsor ID
- STU00202270
- Conditions
- Lichen Sclerosus, Lichen Sclerosus et Atrophicus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigator is no longer at Northwestern University
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 26 Aug 2016 (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.
The study aims to validate a vulvar scarring grading scale for lichen sclerosus (LS).
Detailed description
Utilizing the vulvar disorders registry, protocol #STU00001056, the research team seeks to analyze the medical record data, including standard of care vulvar photographs, of the vulvar LS population at Northwestern Memorial Hospital (NMH) and the outpatient clinics of Northwestern Medicine (NM). These photographs will be used to develop a vulvar scarring grading scale for LS. The objective measurement of scarring severity in LS deidentified standard-of-care patient photographs will be correlated with clinical examination findings to assess validity of the grading scale. The development of an objective and standardized grading scale will assist with the longitudinal evaluation of individual disease, assessment of impact of therapy on scarring, and inform treatment modifications. Further, objective grading of scarring would also provide the opportunity to search for potential correlation between QoL scores and severity of clinical states in scarring dermatoses.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female subjects from the Northwestern University Vulvar Mucosal Specialty Clinic, with histologically confirmed diagnosis of vulvar lichen sclerosus
Key inclusion criteria (2 listed)
- Patients seen at Northwestern Medicine Department of Dermatology and/or Department of Obstetrics and Gynecology, who were seen by Dr. Bethanee Schlosser, and/or other members of the Vulvar Mucosal Specialty Clinic team in any of their respective clinic settings and underwent complete mucocutaneous examination.
- Patients with histologically confirmed vulvar LS.
Key exclusion criteria (3 listed)
- Patients who refuse complete mucocutaneous examination.
- Patients who refuse recommended diagnostic procedures.
- Pregnant women or prisoners.
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 |
|---|---|---|
| PhotographyPhotos will be taken of the vulvar lichen sclerosus lesions. | Other | – |
Primary outcome
Scarring severity grading scale for vulvar lichen sclerosus
Time frame: one year
1 secondary outcome
Correlation of severity of vulvar LS scarring, as documented at time of clinical examination and compared to scores on the LS grading scale, with the patient quality of life at the time of examination.
Time frame: one year
Results and safety
The study was stopped early (reason given: Investigator is no longer at Northwestern University). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Results publication: PubMed 12418071Hansen A, Carr K, Jensen JT. Characteristics and initial diagnoses in women presenting to a referral center for vulvovaginal disorders in 1996-2000. J Reprod Med. 2002 Oct;47(10):854-60.
- Results publication: PubMed 16176512Gokdemir G, Baksu B, Baksu A, Davas I, Koslu A. Features of patients with vulvar dermatoses in dermatologic and gynecologic practice in Turkey: is there a need for an interdisciplinary approach? J Obstet Gynaecol Res. 2005 Oct;31(5):427-31. doi: 10.1111/j.1447-0756.2005.00314.x.
- Results publication: PubMed 20868406McPherson T, Cooper S. Vulval lichen sclerosus and lichen planus. Dermatol Ther. 2010 Sep-Oct;23(5):523-32. doi: 10.1111/j.1529-8019.2010.01355.x.
- Results publication: PubMed 16130842Goldstein AT, Marinoff SC, Christopher K, Srodon M. Prevalence of vulvar lichen sclerosus in a general gynecology practice. J Reprod Med. 2005 Jul;50(7):477-80.
- Results publication: PubMed 25608255Schlosser BJ, Mirowski GW. Lichen sclerosus and lichen planus in women and girls. Clin Obstet Gynecol. 2015 Mar;58(1):125-42. doi: 10.1097/GRF.0000000000000090.
- Results publication: PubMed 20522071Bradford J, Fischer G. Long-term management of vulval lichen sclerosus in adult women. Aust N Z J Obstet Gynaecol. 2010 Apr;50(2):148-52. doi: 10.1111/j.1479-828X.2010.01142.x.
- Individual participant dataSharing planned: No
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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.
Bethanee J Schlosser, MD, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lichen Sclerosus and Lichen Sclerosus et Atrophicus, run by Northwestern University at 1 site in United States.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 9 Oct 2020. 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 United States. 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 was stopped early (reason given: Investigator is no longer at Northwestern University). Results are not available in the source record.
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?
Scarring severity grading scale for vulvar lichen sclerosus (time frame: one year). 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 NCT02880904, which also lists 6 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 9 Oct 2020; AzTrials last refreshed its copy on 30 Oct 2026.