title: Avocado and soybean extracts as active principles in the treatment of mild-to-moderate vulvar lichen sclerosus: results of efficacy and tolerability.
abstract: OBJECTIVE
  Limited evidence is available on the effectiveness of treatments alternative to corticosteroids for vulvar lichen sclerosus (VLS). The present study aimed to assess the efficacy and tolerability of avocado and soybean extracts (ASE) as active principles of both a topical product and a nutritional supplement in the treatment of active mild-to-moderate VLS.
  
  
  METHODS
  Twenty-three patients were enrolled. Treatment consisted of a topical product containing ASE and other lenitive and anti-oxidant principles administered twice daily for 24 weeks, in association with a dietary supplement containing ASE, vitamin E and para-aminobenzoic acid for the first 12 weeks. The primary efficacy endpoint was the rate of patients achieving an improvement from baseline in global subjective score (GSS) and global objective score (GOS) of ≥ 75%. Secondary efficacy endpoint was the rate of patients achieving GSS50 and GOS50. Tertiary efficacy endpoint was the mean reduction in subjective and objective scores throughout the treatment.
  
  
  RESULTS
  By the end of the 24-week treatment, 12 (70.5% of symptomatic patients) and 13 patients (72.2%) achieved an improvement of at least 75% in subjective and objective global scores, respectively; 100% and 88.9% reached GSS50 and GOS50, respectively. Mean symptom and sign scores decreased significantly after treatment. The treatment was well tolerated.
  
  
  CONCLUSIONS
  Our results provide evidence that the topical and dietary supplements used in the study, which contain active principles exerting anti-inflammatory, anti-fibrotic, emollient and lenitive actions, are effective alternatives in the treatment of symptoms and signs of mild-to-moderate VLS.
authors.affiliation: Dipartimento di Scienze Mediche, Sezione di Dermatologia e Malattie Infettive, Università degli Studi di Ferrara, Ferrara, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Borghi
authors.affiliation: Dipartimento di Scienze Mediche, Sezione di Dermatologia e Malattie Infettive, Università degli Studi di Ferrara, Ferrara, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Corazza
authors.affiliation: Dipartimento di Scienze Mediche, Sezione di Dermatologia e Malattie Infettive, Università degli Studi di Ferrara, Ferrara, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Minghetti
authors.affiliation: Dipartimento di Scienze Mediche, Sezione di Dermatologia e Malattie Infettive, Università degli Studi di Ferrara, Ferrara, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Toni
authors.affiliation: Dipartimento di Scienze Mediche, Sezione di Dermatologia e Malattie Infettive, Università degli Studi di Ferrara, Ferrara, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Virgili
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000975:Antioxidants / Q000008:administration & dosage / Q000009:adverse effects; D019587:Dietary Supplements / Q000009:adverse effects; D005260:Female; D006801:Humans; D008875:Middle Aged; D027421:Persea; D008517:Phytotherapy; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D011379:Prognosis; D011446:Prospective Studies; D012720:Severity of Illness Index; D063465:Skin Cream / Q000627:therapeutic use; D013025:Glycine max; D016896:Treatment Outcome; D007724:Vulvar Lichen Sclerosus / Q000188:drug therapy* / Q000473:pathology; D055815:Young Adult
chemical_list: D000975:Antioxidants; D010936:Plant Extracts