Lichen Sclerosus of VulvaNCT03045172
Platelet Rich Plasma (PRP) for Vulvar Lichen Sclerosus
A study testing Platelet Rich Plasma in people with Lichen Sclerosus of Vulva, run by Center for Vulvovaginal Disorders at 1 site in United States.
Trial summary
Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which may cause significant sexual dysfunction or pain. Lastly, 4-6% of women with LS will develop vulvar cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lichen Sclerosus of Vulva
- What is being tested?
- Platelet Rich Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Oct 2018
- 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
- Female, 18 year or older
- With a diagnosis of biopsy proven active vulvar lichen sclerosus
- Signed written informed consent
- Willingness and ability to comply with the study requirements
- Subject must have a score of 5 or greater in the itching (pruritus) domain of the CSS upon enrollment
Who cannot join
- Who have received systemic immunosuppressants (e.g. corticosteroids) within 12 weeks prior to participation in the study
- Who have been treated with topical therapy (e.g. topical corticosteroids, topical calcineurin inhibitors, topical estrogen, topical testosterone) at the affected area within 16 weeks prior to participation in the study.
- Who are immunocompromised (e.g. lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease
- Who suffer from systemic of generalized infections (bacterial, viral, or fungal)
- Who have been diagnosed with lichen planus, psoriasis, candidiasis, intraepithelial neoplasia, or carcinoma of the vulva
- Who had received an investigational drug within four weeks prior to the study or who intend to use other investigational drugs during the course of this study.
Show all 9Show fewer
- Patients with severe medical conditions(s) that in the view of the investigator prohibits participation in the study.
- Who have a history of substance abuse of any factor, which limits the subject's ability to cooperate in the study procedure
- Who are uncooperative, known to miss appointments (according to subjects' records) and are unlikely to follow medical instructions pr are not willing to attend regularly scheduled visits.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Vulvovaginal Disorders
Washington D.C., District of Columbia, 20037
About this study
Official title: A Double Blind Placebo Controlled Trial of Autologous Platelet Rich Plasma (PRP) Intradermal Injections for the Treatment of Vulvar Lichen Sclerosus
Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which may cause significant sexual dysfunction or pain. Lastly, 4-6% of women with LS will develop vulvar cancer.
The current "gold standard" treatment for lichen sclerosus is potent steroids creams. When used correctly, steroid creams help to decrease the symptoms of itching and burning and can prevent further vulvar scarring. In addition, proper treatment reverses the underlying inflammation of LS, and may lower the risk of getting cancer. While useful, steroid creams may have serious side effects that include thinning of the skin, fungal infections, and lowering the immune system.
Read more
Platelet-rich plasma (PRP) is a platelet concentrate that helps to speed up tissue healing, without serious side effects, in a very wide range of medical conditions such as diabetic foot ulcers, muscle injury, tendon injury, and in a variety of cosmetic procedures. The PRP works because of its high level of proteins that help with wound healing. It is also apparent from the majority of published studies that PRP therapy has minimal risk of scar tissue formation or significant bad side effects.
Recently, there was an exploratory study of twelve subjects that used PRP for the study treatment of lichen sclerosus. While this study showed good success, the study was limited because of its small size and lack of placebo (a drug or study treatment that contains no active ingredient) control.
Read the detailed description
This will be a randomized single-blind placebo controlled trial to evaluate the efficacy and safety of autologous Platelet-rich Plasma (PRP) for the treatment of vulvar lichen sclerosus. Thirty patients with a diagnosis of biopsy proven active vulvar lichen sclerosus will be recruited from one center. This study will consist of a two-week screening period and a 12-week treatment period. At the beginning of the screening period, a 4 millimeter punch skin biopsy sample will be collected from each patient to confirm the diagnosis of active lichen sclerosus and to rule out the diagnoses of lichen planus, psoriasis, candidiasis, and vulvar intraepithelial neoplasia. In addition, vulvoscopy will be performed at the screening visit and after the 12-week treatment period to rule out vulvar carcinoma. All eligible patients will be randomized to receive either placebo (saline injections) (10 subjects) or two separate treatments of PRP separated by 6 weeks (20 subjects). Each treatment would consist of an injection of 5 ml of autologous platelet-rich plasma (PRP) injected subdermally and intra-dermally, infiltrating the areas of the vulva affected by active lichen sclerosus. A repeat biopsy will be performed adjacent to the original biopsy site at the 12 week visit.
The preparation of autologous PRP is as follows: 60 cc of whole blood will be removed via venopuncture. Preparation of PRP is done using a proprietary, FDA approved, centrifuge which uses a laser and a closed sterile system to identify and isolate the most platelet rich fraction of 60ml of whole blood. [Magellan® Autologous Platelet Separator System. Arteriocyte Medical Systems. Hopkinton, MA USA].
The PRP will be collected in a blackened syringe so that neither Dr. Goldstein (the physician administering the PRP) nor the patient will know if she is receiving the PRP or placebo.
After isolation of the PRP, calcium chloride (0.7ml) will be added to the 5 ml of PRP isolate to activate the thrombin cascade, thereby causing degranulation of platelets, releasing growth factors and cytokines, and starting the transformation of the PRP to platelet rich fibrin matrix (PRFM).
The primary efficacy variable will be performed by a blinded dermatopathologist who will evaluate the inflammatory infiltration on biopsy specimens obtained during the screening period and at the Week 14 visit (1 to 4 scales). A secondary endpoint will be changes from baseline in the "Clinical Scoring System for Vulvar Lichen Sclerosus" (CSS) a validated instrument that assessment both an investigator's impression of the severity of disease and a patient's impression of the severity of her disease.
All adverse events will be recorded, including serious adverse events. A physical examination will be performed at each visit.
- Conditions
- Lichen Sclerosus of Vulva
- Being tested
- Platelet Rich Plasma, Placebo
- Keywords
- Lichen Sclerosus, Platelet Rich Plasma, Vulvar, Vulva
- Medical subject headings
- Vulvar Lichen Sclerosus, Lichen Sclerosus et Atrophicus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaBiological
PRP
PlaceboDrug
Saline
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 20 subjects with Platelet Rich Plasma injections Receives: Biological: Platelet Rich Plasma |
| Group 2 | Placebo comparator | 10 subjects with placebo injections Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Scoring System for Vulvar Lichen Sclerosus
A validated instrument that assesses both the investigator's impression of the severity of disease and a patient's impression of the severity of her disease pre and post-intervention.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study startNov 2016
- Primary completionAug 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Lichen Sclerosus of VulvaStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Vulvovaginal Disorders
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew T Goldstein, MD, Principal investigator, The Center for Vulvovaginal Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045172
- Sponsor's protocol ID
- GCRF-1
- Status last verified
- Oct 2018
- First submitted
- 1 Feb 2017
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pierard GE, Pierard-Franchimont C, Ben Mosbah T, Arrese Estrada J. Adverse effects of topical corticosteroids. Acta Derm Venereol Suppl (Stockh). 1989;151:26-30; discussion 47-52.
PubMed 2624063Lubach D, Rath J, Kietzmann M. Steroid-induced dermal thinning: discontinuous application of clobetasol-17-propionate ointment. Dermatology. 1992;185(1):44-8. doi: 10.1159/000247402.
PubMed 1638070Cherian MP, AbdulJabbar M. Cushing's syndrome and adrenal suppression from percutaneous absorption of clobetasol propionate in infants. Saudi Med J. 2001 Dec;22(12):1139-41. No abstract available.
PubMed 11802195Furue M, Terao H, Rikihisa W, Urabe K, Kinukawa N, Nose Y, Koga T. Clinical dose and adverse effects of topical steroids in daily management of atopic dermatitis. Br J Dermatol. 2003 Jan;148(1):128-33. doi: 10.1046/j.1365-2133.2003.04934.x.
PubMed 12534606Sarvajnamurthy S, Suryanarayan S, Budamakuntala L, Suresh DH. Autologous platelet rich plasma in chronic venous ulcers: study of 17 cases. J Cutan Aesthet Surg. 2013 Apr;6(2):97-9. doi: 10.4103/0974-2077.112671.
PubMed 24023432Sclafani AP. Safety, efficacy, and utility of platelet-rich fibrin matrix in facial plastic surgery. Arch Facial Plast Surg. 2011 Jul-Aug;13(4):247-51. doi: 10.1001/archfacial.2011.3. Epub 2011 Feb 21.
PubMed 21339469Chen L, Yang X, Huang G, Song D, Ye XS, Xu H, Li W. Platelet-rich plasma promotes healing of osteoporotic fractures. Orthopedics. 2013 Jun;36(6):e687-94. doi: 10.3928/01477447-20130523-10.
PubMed 23746028Goldstein AT, King M, Runels C, Gloth M, Pfau R. Intradermal injection of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus. J Am Acad Dermatol. 2017 Jan;76(1):158-160. doi: 10.1016/j.jaad.2016.07.037. No abstract available.
PubMed 27986140Lubkowska A, Dolegowska B, Banfi G. Growth factor content in PRP and their applicability in medicine. J Biol Regul Homeost Agents. 2012 Apr-Jun;26(2 Suppl 1):3S-22S.
PubMed 23648195Salazar-Alvarez AE, Riera-del-Moral LF, Garcia-Arranz M, Alvarez-Garcia J, Concepcion-Rodriguez NA, Riera-de-Cubas L. Use of platelet-rich plasma in the healing of chronic ulcers of the lower extremity. Actas Dermosifiliogr. 2014 Jul-Aug;105(6):597-604. doi: 10.1016/j.ad.2013.12.011. Epub 2014 Mar 12. English, Spanish.
PubMed 24630241Moraes VY, Lenza M, Tamaoki MJ, Faloppa F, Belloti JC. Platelet-rich therapies for musculoskeletal soft tissue injuries. Cochrane Database Syst Rev. 2013 Dec 23;(12):CD010071. doi: 10.1002/14651858.CD010071.pub2.
PubMed 24363098Casabona F, Priano V, Vallerino V, Cogliandro A, Lavagnino G. New surgical approach to lichen sclerosus of the vulva: the role of adipose-derived mesenchymal cells and platelet-rich plasma in tissue regeneration. Plast Reconstr Surg. 2010 Oct;126(4):210e-211e. doi: 10.1097/PRS.0b013e3181ea9386. No abstract available.
PubMed 20885230Gunthert AR, Duclos K, Jahns BG, Krause E, Amann E, Limacher A, Mueller MD, Juni P. Clinical scoring system for vulvar lichen sclerosus. J Sex Med. 2012 Sep;9(9):2342-50. doi: 10.1111/j.1743-6109.2012.02814.x. Epub 2012 Jul 3.
PubMed 22759453
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Placebo Controlled Trial of Autologous Platelet Rich Plasma (PRP) Intradermal Injections for the Treatment of Vulvar Lichen Sclerosus
- ClinicalTrials.gov ID
- NCT03045172
- Acronym / sponsor ID
- GCRF-1
- Conditions
- Lichen Sclerosus of Vulva
- Keywords
- Lichen Sclerosus, Platelet Rich Plasma, Vulvar, Vulva
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Center for Vulvovaginal DisordersUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 7 Feb 2017 (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 (LS) is a skin condition of the external genitals (vulva) of women. LS causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which may cause significant sexual dysfunction or pain. Lastly, 4-6% of women with LS will develop vulvar cancer.
The current "gold standard" treatment for lichen sclerosus is potent steroids creams. When used correctly, steroid creams help to decrease the symptoms of itching and burning and can prevent further vulvar scarring. In addition, proper treatment reverses the underlying inflammation of LS, and may lower the risk of getting cancer. While useful, steroid creams may have serious side effects that include thinning of the skin, fungal infections, and lowering the immune system.
Platelet-rich plasma (PRP) is a platelet concentrate that helps to speed up tissue healing, without serious side effects, in a very wide range of medical conditions such as diabetic foot ulcers, muscle injury, tendon injury, and in a variety of cosmetic procedures. The PRP works because of its high level of proteins that help with wound healing. It is also apparent from the majority of published studies that PRP therapy has minimal risk of scar tissue formation or significant bad side effects.
Recently, there was an exploratory study of twelve subjects that used PRP for the study treatment of lichen sclerosus. While this study showed good success, the study was limited because of its small size and lack of placebo (a drug or study treatment that contains no active ingredient) control.
Detailed description
This will be a randomized single-blind placebo controlled trial to evaluate the efficacy and safety of autologous Platelet-rich Plasma (PRP) for the treatment of vulvar lichen sclerosus. Thirty patients with a diagnosis of biopsy proven active vulvar lichen sclerosus will be recruited from one center. This study will consist of a two-week screening period and a 12-week treatment period. At the beginning of the screening period, a 4 millimeter punch skin biopsy sample will be collected from each patient to confirm the diagnosis of active lichen sclerosus and to rule out the diagnoses of lichen planus, psoriasis, candidiasis, and vulvar intraepithelial neoplasia. In addition, vulvoscopy will be performed at the screening visit and after the 12-week treatment period to rule out vulvar carcinoma. All eligible patients will be randomized to receive either placebo (saline injections) (10 subjects) or two separate treatments of PRP separated by 6 weeks (20 subjects). Each treatment would consist of an injection of 5 ml of autologous platelet-rich plasma (PRP) injected subdermally and intra-dermally, infiltrating the areas of the vulva affected by active lichen sclerosus. A repeat biopsy will be performed adjacent to the original biopsy site at the 12 week visit.
The preparation of autologous PRP is as follows: 60 cc of whole blood will be removed via venopuncture. Preparation of PRP is done using a proprietary, FDA approved, centrifuge which uses a laser and a closed sterile system to identify and isolate the most platelet rich fraction of 60ml of whole blood. [Magellan® Autologous Platelet Separator System. Arteriocyte Medical Systems. Hopkinton, MA USA].
The PRP will be collected in a blackened syringe so that neither Dr. Goldstein (the physician administering the PRP) nor the patient will know if she is receiving the PRP or placebo.
After isolation of the PRP, calcium chloride (0.7ml) will be added to the 5 ml of PRP isolate to activate the thrombin cascade, thereby causing degranulation of platelets, releasing growth factors and cytokines, and starting the transformation of the PRP to platelet rich fibrin matrix (PRFM).
The primary efficacy variable will be performed by a blinded dermatopathologist who will evaluate the inflammatory infiltration on biopsy specimens obtained during the screening period and at the Week 14 visit (1 to 4 scales). A secondary endpoint will be changes from baseline in the "Clinical Scoring System for Vulvar Lichen Sclerosus" (CSS) a validated instrument that assessment both an investigator's impression of the severity of disease and a patient's impression of the severity of her disease.
All adverse events will be recorded, including serious adverse events. A physical examination will be performed at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Biological: Platelet Rich Plasma20 subjects with Platelet Rich Plasma injections |
| Group 2 | Placebo comparator | Drug: Placebo10 subjects with placebo injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female, 18 year or older
- With a diagnosis of biopsy proven active vulvar lichen sclerosus
- Signed written informed consent
- Willingness and ability to comply with the study requirements
- Subject must have a score of 5 or greater in the itching (pruritus) domain of the CSS upon enrollment
Key exclusion criteria (9 listed)
- Who have received systemic immunosuppressants (e.g. corticosteroids) within 12 weeks prior to participation in the study
- Who have been treated with topical therapy (e.g. topical corticosteroids, topical calcineurin inhibitors, topical estrogen, topical testosterone) at the affected area within 16 weeks prior to participation in the study.
- Who are immunocompromised (e.g. lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease
- Who suffer from systemic of generalized infections (bacterial, viral, or fungal)
- Who have been diagnosed with lichen planus, psoriasis, candidiasis, intraepithelial neoplasia, or carcinoma of the vulva
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 |
|---|---|---|
| Platelet Rich PlasmaPRP | Biological | Group 1 |
| PlaceboSaline | Drug | Group 2 |
Primary outcome
Clinical Scoring System for Vulvar Lichen Sclerosus
Time frame: 14 weeks
A validated instrument that assesses both the investigator's impression of the severity of disease and a patient's impression of the severity of her disease pre and post-intervention.
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 25 Oct 2018.
- Background: PubMed 2624063Pierard GE, Pierard-Franchimont C, Ben Mosbah T, Arrese Estrada J. Adverse effects of topical corticosteroids. Acta Derm Venereol Suppl (Stockh). 1989;151:26-30; discussion 47-52.
- Background: PubMed 1638070Lubach D, Rath J, Kietzmann M. Steroid-induced dermal thinning: discontinuous application of clobetasol-17-propionate ointment. Dermatology. 1992;185(1):44-8. doi: 10.1159/000247402.
- Background: PubMed 11802195Cherian MP, AbdulJabbar M. Cushing's syndrome and adrenal suppression from percutaneous absorption of clobetasol propionate in infants. Saudi Med J. 2001 Dec;22(12):1139-41. No abstract available.
- Background: PubMed 12534606Furue M, Terao H, Rikihisa W, Urabe K, Kinukawa N, Nose Y, Koga T. Clinical dose and adverse effects of topical steroids in daily management of atopic dermatitis. Br J Dermatol. 2003 Jan;148(1):128-33. doi: 10.1046/j.1365-2133.2003.04934.x.
- Background: PubMed 24023432Sarvajnamurthy S, Suryanarayan S, Budamakuntala L, Suresh DH. Autologous platelet rich plasma in chronic venous ulcers: study of 17 cases. J Cutan Aesthet Surg. 2013 Apr;6(2):97-9. doi: 10.4103/0974-2077.112671.
- Background: PubMed 21339469Sclafani AP. Safety, efficacy, and utility of platelet-rich fibrin matrix in facial plastic surgery. Arch Facial Plast Surg. 2011 Jul-Aug;13(4):247-51. doi: 10.1001/archfacial.2011.3. Epub 2011 Feb 21.
- Background: PubMed 23746028Chen L, Yang X, Huang G, Song D, Ye XS, Xu H, Li W. Platelet-rich plasma promotes healing of osteoporotic fractures. Orthopedics. 2013 Jun;36(6):e687-94. doi: 10.3928/01477447-20130523-10.
- Background: PubMed 27986140Goldstein AT, King M, Runels C, Gloth M, Pfau R. Intradermal injection of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus. J Am Acad Dermatol. 2017 Jan;76(1):158-160. doi: 10.1016/j.jaad.2016.07.037. No abstract available.
- Background: PubMed 23648195Lubkowska A, Dolegowska B, Banfi G. Growth factor content in PRP and their applicability in medicine. J Biol Regul Homeost Agents. 2012 Apr-Jun;26(2 Suppl 1):3S-22S.
- Background: PubMed 24630241Salazar-Alvarez AE, Riera-del-Moral LF, Garcia-Arranz M, Alvarez-Garcia J, Concepcion-Rodriguez NA, Riera-de-Cubas L. Use of platelet-rich plasma in the healing of chronic ulcers of the lower extremity. Actas Dermosifiliogr. 2014 Jul-Aug;105(6):597-604. doi: 10.1016/j.ad.2013.12.011. Epub 2014 Mar 12. English, Spanish.
- Background: PubMed 24363098Moraes VY, Lenza M, Tamaoki MJ, Faloppa F, Belloti JC. Platelet-rich therapies for musculoskeletal soft tissue injuries. Cochrane Database Syst Rev. 2013 Dec 23;(12):CD010071. doi: 10.1002/14651858.CD010071.pub2.
- Background: PubMed 20885230Casabona F, Priano V, Vallerino V, Cogliandro A, Lavagnino G. New surgical approach to lichen sclerosus of the vulva: the role of adipose-derived mesenchymal cells and platelet-rich plasma in tissue regeneration. Plast Reconstr Surg. 2010 Oct;126(4):210e-211e. doi: 10.1097/PRS.0b013e3181ea9386. No abstract available.
- 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.
Andrew T Goldstein, MD principal investigator
The Center for Vulvovaginal Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Plasma in people with Lichen Sclerosus of Vulva, run by Center for Vulvovaginal Disorders 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 5 inclusion and 9 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 25 Oct 2018. 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. Some participants in this study may receive a placebo. 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 Scoring System for Vulvar Lichen Sclerosus (time frame: 14 weeks). 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 NCT03045172, which also lists 13 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 25 Oct 2018; AzTrials last refreshed its copy on 6 Nov 2026.