Vulvar Lichen SclerosusPhase 2NCT03961126

Evaluation of Vulvar Lichen Sclerosus Treatment Using Adipose Tissue Associated With Autologous Platelet-rich Plasma.

A Phase 2 study testing Injection of autologous fatty tissue associated with autologous platelet-rich plasma. and Corticosteroids (clobetasol 0.05%) in people with Vulvar Lichen Sclerosus, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

LIQUENIA clinical trial is a phase II, controlled, prospective and unicentric study to assess vulvar lichen sclerosus (VLS) treatment using adipose tissue associated with autologous platelet-rich plasma (PRP) coming from the inner side of the patients' thighs, which aims to restore the structure and elasticity of the… Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Vulvar Lichen Sclerosus
What is being tested?: Injection of autologous fatty tissue associated with autologous platelet-rich plasma. and Corticosteroids (clobetasol 0.05%)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteSpain
Study dates: 6 Sep 2017to 12 Dec 2019
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 18 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult women between 18 and 70 years old.
Patients with clear clinical and/or histological diagnosis of vulvar lichen sclerosus (VLS).
Moderate to severe affectation of the disease at genital level.
Patients who have taken topical treatment for at least three months with 0.05% clobetasol propionate.
Prior signed informed consent form.

Who cannot join

Pregnant or lactating women.
Alcoholic patients.
Patients with malignant disease diagnosed in the last 5 years.
Patients infected with HSV-II, HPV, HIV, HBV and HCV viruses.
Injecting drug users.
Patients with serious active infectious diseases.

Show all 9Show fewer

Patients with known allergy or intolerance to any of the aforementioned treatments.
Patients with inflammatory diseases that may affect the vulvar area (Crohn's disease, ulcerative colitis, psoriasis, eczema).
Patients with unrealistic expectations regarding the final benefits of the treatment.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Universitario y Politécnico La Fe
Valencia

Other trials in Spain

About this study

Official title: Pilot Study of Vulvar Lichen Sclerosus (VLS) Treatment Using Adipose Tissue Associated With Autologous Platelet-rich Plasma (PRP).

Read the detailed description

Randomized, prospective and unicentric study, in which the investigators evaluate patients with vulvar lichen sclerosus who undergo surgical treatment consisting of two separate infiltrations by intra and subdermal injection in each half vulvar of autologous fatty tissue associated with autologous platelet-rich plasma, in order to:

Main objective:

To estimate the population parameters of the study variables, as well as their variability, to be able to determine the sample size and statistical power for a future clinical trial whose main objective will be to demonstrate the efficacy of this treatment regarding the increase in the vulvar elasticity in patients with vulvar lichen sclerosus.

Secondary Objectives:

To evaluate if there is a structural improvement in the vulva areas treated at month, 3 months, 6 months and 12 months after the first infiltration and at 3 and 9 months after the second infiltration.
To analysis the improvement of fibrosis and inflammation 6 months after the first infiltration and 3 months after the second infiltration.
To study if there is an improvement in symptoms at month, 3 months, 6 months, 12 months after the first infiltration and at 3 months and 9 months after the second infiltration.
To examine whether there is an improvement in the quality of patients life.
Subsequent use of clinical and pain assessment scale in this study and in another lichen sclerosus vulvar studies with a greater number of patients.
To evaluate the adverse events derived from the treatment during the first year after the first infiltration through its registration in the CRD.

Conditions: Vulvar Lichen Sclerosus
Being tested: Injection of autologous fatty tissue associated with autologous platelet-rich plasma., Corticosteroids (clobetasol 0.05%)
Keywords: Vulvar Lichen Sclerosus, Autologous Platelet-rich Plasma (PRP)
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.

Injection of autologous fatty tissue associated with autologous platelet-rich plasma.Drug
Also called Experimental
Patients will receive 2 separate infiltrations for three months by intra and subdermal injection of autologous fatty tissue (20cc) associated with autologous platelet-rich plasma (4cc) in each half vulvar.
Corticosteroids (clobetasol 0.05%)Drug
Also called Control
Patients will receive a maintenance treatment of topical therapy with corticosteroids (clobetasol 0.05%) that will be administered by usual clinical practice.

Study groups in NCT03961126
Study group	Role	What they receive
Group autologous platelet-rich plasma injection	Experimental	Patients will receive 2 separate infiltrations for three months by intra and subdermal injection of autologous fatty tissue (20cc) associated with autologous platelet-rich plasma (4cc) in each half vulvar. Receives: Drug: Injection of autologous fatty tissue associated with autologous platelet-rich plasma.
Group Control	Active comparator	Patients will receive a maintenance treatment of topical therapy with corticosteroids (clobetasol 0.05%) that will be administered by usual clinical practice. Receives: Drug: Corticosteroids (clobetasol 0.05%)

What is being measured

The primary outcome is the main question the study is designed to answer.

Vulvar elasticity measured by the cutometer-dualmpa®
Vulvar elasticity will be measured by the cutometer-dualmpa® for the analysis of the elasticity improvement in the plaques of fibrosis at the affected vulvar areas.
Measured: Month 1 after first infiltration.
Vulvar elasticity measured by the cutometer-dualmpa®
Vulvar elasticity will be measured by the cutometer-dualmpa® for the analysis of the elasticity improvement in the plaques of fibrosis at the affected vulvar areas.
Measured: Month 3 after first infiltration.
Vulvar elasticity measured by the cutometer-dualmpa®
Vulvar elasticity will be measured by the cutometer-dualmpa® for the analysis of the elasticity improvement in the plaques of fibrosis at the affected vulvar areas.
Measured: Month 6 after first infiltration.
Vulvar elasticity measured by the cutometer-dualmpa®
Vulvar elasticity will be measured by the cutometer-dualmpa® for the analysis of the elasticity improvement in the plaques of fibrosis at the affected vulvar areas.
Measured: Year 1 after first infiltration.
Vulvar elasticity measured by the cutometer-dualmpa®
Vulvar elasticity will be measured by the cutometer-dualmpa® for the analysis of the elasticity improvement in the plaques of fibrosis at the affected vulvar areas.
Measured: Month 3 after second infiltration.
Vulvar elasticity measured by the cutometer-dualmpa®
Vulvar elasticity will be measured by the cutometer-dualmpa® for the analysis of the elasticity improvement in the plaques of fibrosis at the affected vulvar areas.
Measured: Month 9 after second infiltration.

Secondary outcomes (6)

Histological improvement measured by the scale for histological assessment.
The histological improvement will be determined in the treatment group by histological comparison of the biopsy samples taken pre-treatment and after 6 months of treatment, and it will be assessed by the evolution of the advanced stages (basal lamina destruction, orthokeratosis, hypergranulocytosis with an infiltrate of lymphocytes and melanophages with Civatte bodies (necrotic keratinocytes) in the papillary dermis) to earlier stages characterized by dermatitis with lymphocytic infiltrate along the epithelial junction.
Measured: Month 6
Improvement in the quality of patients' life measured by skindex-29 questionnaire quality of life.
The skindex-29 is a questionnaire designed for assessing aspects, such as degree of symptoms, psychosocial functioning, and emotional status, for assessing the effects of skin diseases on patient's quality of life.
Measured: Month 1, Month 3, Month 6, Year 1
Improvement in the clinical symptoms by clinical assessment scale.
Clinical assessment scale is a physical examination for current status of the lesions despite treatment with topical corticosteroids. 1 point will be given to the existence of whitish plaques, 2 points to the presence of bruises, hemorrhagic blisters, erosions/ulcers, pain or bleeding during sexual intercourse and 8 points to labial adhesion (minora/major), clítoris phimosis and narrowing of the introitus. The patients with 1 point will be mild patients, the patients with 2-7 points will suffer a moderate affectation while the patients with more than 8 or + points will be in advanced stages with a serious affectation.
Measured: Month 1, Month 3, Month 6, Year 1
Improvement in the pruritus measured by 4D Pruritus Scale.
4D Pruritus Scale is a brief but multidimensional questionnaire to assess itching. The scale scores from 0 (no negative impact) to 4 (greatest negative impact) on pruritus duration, intensity, extent and daily activities disability.
Measured: Month 1, Month 3, Month 6, Year 1
Improvement in the pain measured by Pain Scale.
The pain scale is designed for assessing pain associated with sexual intercourse and urination (2 points), resting and nightime sleep conciliation (6 points).Regarding the gradation of symptoms it will be classified as mild (1 point) the existence of mild pain/discomfort that allows normal life without taking analgesics, moderate (2-5 points) when usual doses of analgesics are required and serious with more than 5 points.
Measured: Month 1, Month 3, Month 6, Year 1
Improvement in sexual performance by Sexual Functioning Index (SFI)
Sexual Functioning Index is a questionnaire related to four topics: sexual activity, sexual intercourse, sexual stimulation and sexual desire.
Measured: Month 1, Month 3, Month 6, Year 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Sep 201712 Dec 2019

First posted23 May 2019
Study start6 Sep 2017
Primary completion12 Dec 2019
Study completion12 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03961126
Sponsor's protocol ID: LIQUENIA
Status last verified: Jun 2020
First submitted: 17 May 2019
Last updated: 11 Jun 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Tausch TJ, Peterson AC. Early aggressive treatment of lichen sclerosus may prevent disease progression. J Urol. 2012 Jun;187(6):2101-5. doi: 10.1016/j.juro.2012.01.071. Epub 2012 Apr 12.
PubMed 22503028
Giuseppina Onesti M, Carella S, Ceccarelli S, Marchese C, Scuderi N. The Use of Human Adipose-Derived Stem Cells in the Treatment of Physiological and Pathological Vulvar Dystrophies. Stem Cells Int. 2016;2016:2561461. doi: 10.1155/2016/2561461. Epub 2016 Jan 10.
PubMed 26880944
Boero V, Brambilla M, Sipio E, Liverani CA, Di Martino M, Agnoli B, Libutti G, Cribiu FM, Del Gobbo A, Ragni E, Bolis G. Vulvar lichen sclerosus: A new regenerative approach through fat grafting. Gynecol Oncol. 2015 Dec;139(3):471-5. doi: 10.1016/j.ygyno.2015.10.014. Epub 2015 Oct 21.
PubMed 26499935
Tamburino S, Lombardo GA, Tarico MS, Perrotta RE. The Role of Nanofat Grafting in Vulvar Lichen Sclerosus: A Preliminary Report. Arch Plast Surg. 2016 Jan;43(1):93-5. doi: 10.5999/aps.2016.43.1.93. Epub 2016 Jan 15. No abstract available.
PubMed 26848453
Focseneanu MA, Gupta M, Squires KC, Bayliss SJ, Berk D, Merritt DF. The course of lichen sclerosus diagnosed prior to puberty. J Pediatr Adolesc Gynecol. 2013 Jun;26(3):153-5. doi: 10.1016/j.jpag.2012.12.002. Epub 2013 Mar 16.
PubMed 23507004
Gale KL, Rakha EA, Ball G, Tan VK, McCulley SJ, Macmillan RD. A case-controlled study of the oncologic safety of fat grafting. Plast Reconstr Surg. 2015 May;135(5):1263-1275. doi: 10.1097/PRS.0000000000001151.
PubMed 25919241
Sinno S, Wilson S, Brownstone N, Levine SM. Current Thoughts on Fat Grafting: Using the Evidence to Determine Fact or Fiction. Plast Reconstr Surg. 2016 Mar;137(3):818-824. doi: 10.1097/01.prs.0000479966.52477.8b.
PubMed 26910662
Sehgal VN, Pandhi D, Khurana A. Nonspecific genital ulcers. Clin Dermatol. 2014 Mar-Apr;32(2):259-74. doi: 10.1016/j.clindermatol.2013.08.024.
PubMed 24559562
Fuh KC, Berek JS. Current management of vulvar cancer. Hematol Oncol Clin North Am. 2012 Feb;26(1):45-62. doi: 10.1016/j.hoc.2011.10.006.
PubMed 22244661
Erickson BA, Elliott SP, Myers JB, Voelzke BB, Smith TG 3rd, McClung CD, Alsikafi NF, Vanni AJ, Brant WO, Broghammer JA, Tam CA, Zhao LC, Buckley JC, Breyer BN; Trauma and Urologic Reconstructive Network of Surgeons. Understanding the Relationship between Chronic Systemic Disease and Lichen Sclerosus Urethral Strictures. J Urol. 2016 Feb;195(2):363-8. doi: 10.1016/j.juro.2015.08.096. Epub 2015 Sep 5.
PubMed 26343349
Arrowsmith S, Kendrick A, Wray S. Drugs acting on the pregnant uterus. Obstet Gynaecol Reprod Med. 2010 Aug;20(8):241-247. doi: 10.1016/j.ogrm.2010.05.001.
PubMed 24443652
Brauer M, van Lunsen R, Burger M, Laan E. Motives for Vulvar Surgery of Women with Lichen Sclerosus. J Sex Med. 2015 Dec;12(12):2462-73. doi: 10.1111/jsm.13052. Epub 2015 Nov 27.
PubMed 26610399
Kreuter A, Kryvosheyeva Y, Terras S, Moritz R, Mollenhoff K, Altmeyer P, Scola N, Gambichler T. Association of autoimmune diseases with lichen sclerosus in 532 male and female patients. Acta Derm Venereol. 2013 Mar 27;93(2):238-41. doi: 10.2340/00015555-1512.
PubMed 23224274
Mazzola RF, Mazzola IC. The fascinating history of fat grafting. J Craniofac Surg. 2013 Jul;24(4):1069-71. doi: 10.1097/SCS.0b013e318292c447. No abstract available.
PubMed 23851740

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Lichen Sclerosus of Vulva
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Efficacy of Collagendep in Reducing Vulvar Dryness in Patients With Lichen Sclerosus Treated With Fat Grafting
Vulvar Lichen Sclerosus, Vulvar Atrophy
Recruiting
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Atrophic Vaginitis, Vaginal Atrophy
Recruiting
Dynamic Quadripolar Radiofrequency VS Topical Corticosteroids in Women With Vulvar Lichen Sclerosus
Vulvar Lichen Sclerosus
RecruitingPhase 2
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Vulvar Lichen Sclerosus

All Vulvar Lichen Sclerosus trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of Vulvar Lichen Sclerosus (VLS) Treatment Using Adipose Tissue Associated With Autologous Platelet-rich Plasma (PRP).
ClinicalTrials.gov ID: NCT03961126
Acronym / sponsor ID: LIQUENIA
Conditions: Vulvar Lichen Sclerosus
Keywords: Vulvar Lichen Sclerosus, Autologous Platelet-rich Plasma (PRP)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
Study start: 6 Sep 2017 (actual)
Primary completion: 12 Dec 2019 (actual)
Study completion: 12 Dec 2019 (actual)
First posted: 23 May 2019 (actual)
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.

Detailed description

Main objective:

Secondary Objectives:

To evaluate if there is a structural improvement in the vulva areas treated at month, 3 months, 6 months and 12 months after the first infiltration and at 3 and 9 months after the second infiltration.
To analysis the improvement of fibrosis and inflammation 6 months after the first infiltration and 3 months after the second infiltration.
To study if there is an improvement in symptoms at month, 3 months, 6 months, 12 months after the first infiltration and at 3 months and 9 months after the second infiltration.
To examine whether there is an improvement in the quality of patients life.
Subsequent use of clinical and pain assessment scale in this study and in another lichen sclerosus vulvar studies with a greater number of patients.
To evaluate the adverse events derived from the treatment during the first year after the first infiltration through its registration in the CRD.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group autologous platelet-rich plasma injection	Experimental	Drug: Injection of autologous fatty tissue associated with autologous platelet-rich plasma.Patients will receive 2 separate infiltrations for three months by intra and subdermal injection of autologous fatty tissue (20cc) associated with autologous platelet-rich plasma (4cc) in each half vulvar.
Group Control	Active comparator	Drug: Corticosteroids (clobetasol 0.05%)Patients will receive a maintenance treatment of topical therapy with corticosteroids (clobetasol 0.05%) that will be administered by usual clinical practice.

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Adult women between 18 and 70 years old.
Patients with clear clinical and/or histological diagnosis of vulvar lichen sclerosus (VLS).
Moderate to severe affectation of the disease at genital level.
Patients who have taken topical treatment for at least three months with 0.05% clobetasol propionate.
Prior signed informed consent form.

Key exclusion criteria (9 listed)

Pregnant or lactating women.
Alcoholic patients.
Patients with malignant disease diagnosed in the last 5 years.
Patients infected with HSV-II, HPV, HIV, HBV and HCV viruses.
Injecting drug users.

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
Injection of autologous fatty tissue associated with autologous platelet-rich plasma.Also: ExperimentalPatients will receive 2 separate infiltrations for three months by intra and subdermal injection of autologous fatty tissue (20cc) associated with autologous platelet-rich plasma (4cc) in each half vulvar.	Drug	Group autologous platelet-rich plasma injection
Corticosteroids (clobetasol 0.05%)Also: ControlPatients will receive a maintenance treatment of topical therapy with corticosteroids (clobetasol 0.05%) that will be administered by usual clinical practice.	Drug	Group Control

Primary outcome

Vulvar elasticity measured by the cutometer-dualmpa®
Time frame: Month 1 after first infiltration.
Vulvar elasticity will be measured by the cutometer-dualmpa® for the analysis of the elasticity improvement in the plaques of fibrosis at the affected vulvar areas.
Vulvar elasticity measured by the cutometer-dualmpa®
Time frame: Month 3 after first infiltration.
Vulvar elasticity will be measured by the cutometer-dualmpa® for the analysis of the elasticity improvement in the plaques of fibrosis at the affected vulvar areas.
Vulvar elasticity measured by the cutometer-dualmpa®
Time frame: Month 6 after first infiltration.
Vulvar elasticity will be measured by the cutometer-dualmpa® for the analysis of the elasticity improvement in the plaques of fibrosis at the affected vulvar areas.
Vulvar elasticity measured by the cutometer-dualmpa®
Time frame: Year 1 after first infiltration.
Vulvar elasticity will be measured by the cutometer-dualmpa® for the analysis of the elasticity improvement in the plaques of fibrosis at the affected vulvar areas.
Vulvar elasticity measured by the cutometer-dualmpa®
Time frame: Month 3 after second infiltration.
Vulvar elasticity will be measured by the cutometer-dualmpa® for the analysis of the elasticity improvement in the plaques of fibrosis at the affected vulvar areas.
Vulvar elasticity measured by the cutometer-dualmpa®
Time frame: Month 9 after second infiltration.
Vulvar elasticity will be measured by the cutometer-dualmpa® for the analysis of the elasticity improvement in the plaques of fibrosis at the affected vulvar areas.

6 secondary outcomes

Histological improvement measured by the scale for histological assessment.
Time frame: Month 6
Improvement in the quality of patients' life measured by skindex-29 questionnaire quality of life.
Time frame: Month 1, Month 3, Month 6, Year 1
Improvement in the clinical symptoms by clinical assessment scale.
Time frame: Month 1, Month 3, Month 6, Year 1
Improvement in the pruritus measured by 4D Pruritus Scale.
Time frame: Month 1, Month 3, Month 6, Year 1
Improvement in the pain measured by Pain Scale.
Time frame: Month 1, Month 3, Month 6, Year 1
Improvement in sexual performance by Sexual Functioning Index (SFI)
Time frame: Month 1, Month 3, Month 6, Year 1

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 11 Jun 2020.
Background: PubMed 22503028Tausch TJ, Peterson AC. Early aggressive treatment of lichen sclerosus may prevent disease progression. J Urol. 2012 Jun;187(6):2101-5. doi: 10.1016/j.juro.2012.01.071. Epub 2012 Apr 12.
Background: PubMed 26880944Giuseppina Onesti M, Carella S, Ceccarelli S, Marchese C, Scuderi N. The Use of Human Adipose-Derived Stem Cells in the Treatment of Physiological and Pathological Vulvar Dystrophies. Stem Cells Int. 2016;2016:2561461. doi: 10.1155/2016/2561461. Epub 2016 Jan 10.
Background: PubMed 26499935Boero V, Brambilla M, Sipio E, Liverani CA, Di Martino M, Agnoli B, Libutti G, Cribiu FM, Del Gobbo A, Ragni E, Bolis G. Vulvar lichen sclerosus: A new regenerative approach through fat grafting. Gynecol Oncol. 2015 Dec;139(3):471-5. doi: 10.1016/j.ygyno.2015.10.014. Epub 2015 Oct 21.
Background: PubMed 26848453Tamburino S, Lombardo GA, Tarico MS, Perrotta RE. The Role of Nanofat Grafting in Vulvar Lichen Sclerosus: A Preliminary Report. Arch Plast Surg. 2016 Jan;43(1):93-5. doi: 10.5999/aps.2016.43.1.93. Epub 2016 Jan 15. No abstract available.
Background: PubMed 23507004Focseneanu MA, Gupta M, Squires KC, Bayliss SJ, Berk D, Merritt DF. The course of lichen sclerosus diagnosed prior to puberty. J Pediatr Adolesc Gynecol. 2013 Jun;26(3):153-5. doi: 10.1016/j.jpag.2012.12.002. Epub 2013 Mar 16.
Background: PubMed 25919241Gale KL, Rakha EA, Ball G, Tan VK, McCulley SJ, Macmillan RD. A case-controlled study of the oncologic safety of fat grafting. Plast Reconstr Surg. 2015 May;135(5):1263-1275. doi: 10.1097/PRS.0000000000001151.
Background: PubMed 26910662Sinno S, Wilson S, Brownstone N, Levine SM. Current Thoughts on Fat Grafting: Using the Evidence to Determine Fact or Fiction. Plast Reconstr Surg. 2016 Mar;137(3):818-824. doi: 10.1097/01.prs.0000479966.52477.8b.
Background: PubMed 24559562Sehgal VN, Pandhi D, Khurana A. Nonspecific genital ulcers. Clin Dermatol. 2014 Mar-Apr;32(2):259-74. doi: 10.1016/j.clindermatol.2013.08.024.
Background: PubMed 22244661Fuh KC, Berek JS. Current management of vulvar cancer. Hematol Oncol Clin North Am. 2012 Feb;26(1):45-62. doi: 10.1016/j.hoc.2011.10.006.
Background: PubMed 26343349Erickson BA, Elliott SP, Myers JB, Voelzke BB, Smith TG 3rd, McClung CD, Alsikafi NF, Vanni AJ, Brant WO, Broghammer JA, Tam CA, Zhao LC, Buckley JC, Breyer BN; Trauma and Urologic Reconstructive Network of Surgeons. Understanding the Relationship between Chronic Systemic Disease and Lichen Sclerosus Urethral Strictures. J Urol. 2016 Feb;195(2):363-8. doi: 10.1016/j.juro.2015.08.096. Epub 2015 Sep 5.
Background: PubMed 24443652Arrowsmith S, Kendrick A, Wray S. Drugs acting on the pregnant uterus. Obstet Gynaecol Reprod Med. 2010 Aug;20(8):241-247. doi: 10.1016/j.ogrm.2010.05.001.
Background: PubMed 26610399Brauer M, van Lunsen R, Burger M, Laan E. Motives for Vulvar Surgery of Women with Lichen Sclerosus. J Sex Med. 2015 Dec;12(12):2462-73. doi: 10.1111/jsm.13052. Epub 2015 Nov 27.
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.

Patricia Gutierrez Ontalvilla principal investigator

Hospital La Fe

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 Jun 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 Spain. 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?

Vulvar elasticity measured by the cutometer-dualmpa® (time frame: Month 1 after first infiltration.). The study lists 6 primary outcomes in all. 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 NCT03961126, which also lists 14 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 11 Jun 2020.