OBJECTIVE: Avoiding potentially irritating contact is a key point in vulvar lichen simplex chronicus (VLSC) management. This study aims to assess the use of nonirritating silk fabric underwear (Dermasilk) as an adjuvant tool in the treatment of VLSC. METHODS:Twenty women with VLSC were enrolled in a 1-week open-label active treatment phase with topical 0.1% mometasone furoate (MMF) ointment. Participants then entered a 4-week double-blind maintenance phase (MP) in which they were randomized to wear either silk fabric or cotton briefs. During MP, participants were allowed to use MMF on an "as-needed" basis. The main efficacy endpoints were to assess and compare the two intervention groups on the following: (1) number of participants who needed to apply MMF throughout MP; (2) mean number of MMF applications; (3) mean symptom-free interval before MMF reapplication; and (4) changes in the severity of symptoms and signs. RESULTS: During MP, four women in the silk fabric briefs group applied MMF compared with six women in the cotton briefs group (relative risk, 0.66). The mean number of MMF applications was lower in the silk fabric briefs group than in the cotton briefs group (P = 0.074). VLSC symptom-free interval was 22.5 days in the silk fabric briefs group and 7.2 days in the cotton briefs group (P = 0.0003). At the end of MP, symptom improvement determined after corticosteroid use increased in the silk fabric briefs group but worsened in the cotton briefs group. CONCLUSIONS:Silk fabric underwear may be a useful tool for the management of VLSC by diminishing external sources of irritation and may reduce use of corticosteroids.
RCT Entities:
OBJECTIVE: Avoiding potentially irritating contact is a key point in vulvar lichen simplex chronicus (VLSC) management. This study aims to assess the use of nonirritating silk fabric underwear (Dermasilk) as an adjuvant tool in the treatment of VLSC. METHODS: Twenty women with VLSC were enrolled in a 1-week open-label active treatment phase with topical 0.1% mometasone furoate (MMF) ointment. Participants then entered a 4-week double-blind maintenance phase (MP) in which they were randomized to wear either silk fabric or cotton briefs. During MP, participants were allowed to use MMF on an "as-needed" basis. The main efficacy endpoints were to assess and compare the two intervention groups on the following: (1) number of participants who needed to apply MMF throughout MP; (2) mean number of MMF applications; (3) mean symptom-free interval before MMF reapplication; and (4) changes in the severity of symptoms and signs. RESULTS: During MP, four women in the silk fabric briefs group applied MMF compared with six women in the cotton briefs group (relative risk, 0.66). The mean number of MMF applications was lower in the silk fabric briefs group than in the cotton briefs group (P = 0.074). VLSC symptom-free interval was 22.5 days in the silk fabric briefs group and 7.2 days in the cotton briefs group (P = 0.0003). At the end of MP, symptom improvement determined after corticosteroid use increased in the silk fabric briefs group but worsened in the cotton briefs group. CONCLUSIONS: Silk fabric underwear may be a useful tool for the management of VLSC by diminishing external sources of irritation and may reduce use of corticosteroids.
Authors: Linn Woelber; Katharina Prieske; Werner Mendling; Barbara Schmalfeldt; Hans-Jürgen Tietz; Anna Jaeger Journal: Dtsch Arztebl Int Date: 2020-02-21 Impact factor: 5.594