Plain English Summary
Background and study aims:
Lichen sclerosus is a long-term skin condition which causes itching and white patches to appear on the skin. The condition most commonly affects the genitalia. The exact cause is unclear however it is thought to be related to over activity of the immune system (the body’s natural defences). Neomercurocromo is a cream used to treat certain skin conditions. Colloidal silver is a mineral which is used as a homeopathic treatment for a range of conditions. The aim of this study is to find out whether treatment with a combination of Neomercurocromo and colloidal silver is effective for treating lichen sclerosus.
Who can participate?
Men with lichen sclerosus present on their genitalia.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are given Neo-Mercurocromo to rub on the affected areas twice a day for two weeks, followed by colloidal silver to apply twice a day for a further two weeks. Those in the second group are given a salt water solution to rub on the affected area twice a day for four weeks. At the start of the study and after one and three months, participants have their lichen sclerosus assessed as well as completing a questionnaire about their quality of life.
What are the possible benefits and risks of participating?
Participants who receive the treatment may benefit from an improvement to their condition or cure. There are no notable risks involved with participating.
Where is the study run from?
Gynepro Medical (Italy)
When is study starting and how long is it expected to run for?
March 2017 to December 2018
Who is funding the study?
Investigators initiated and funded (Italy)
Who is the main contact?
1. Dr Carlo Maretti (scientific)
2. Dr Giorgio Cavallini (public)
Dr Carlo Maretti
via Tranquillo Cremona 8
Dr Giorgio Cavallini
via Tranquillo Cremona 8
Topical application of Neomercurocromo and subsequently of Colloidal Silver (active drugs) or of placebo (NaCl 0.9%) for the treatment of lichen sclerosus: Comparison of efficacy and of safety
The aim of this study is to evaluate the efficacy of the topical treatment of penile lichen sclerosus with Neomercurocromo and later with colloidal silver.
Gynepro Ethics Board, 10/05/2017, ref: CdB 01/2017
Randomised placebo-controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use te contact details below to request a participant information sheet.
Lichen sclerosus of male genitalia
Patients will be randomly assigned to one of the two groups using an online randomizer: https://www.randomizer.org/
Intervention group: Participants receive active drugs (Neo-Mercurocromo and Colloidal Silver). They are instructed to carefully rub a sterile gauze soaked with Neo-Mercurocromo against affected area(s) twice a day for two weeks. The composition of Neo-Mercurocromo is: Eosin 2%, Cloroxilenol 0,3%, Propilenglicol 30%. Following this, patients are instructed to carefully rub a sterile gauze soaked with Colloidal Silver (Argento Colloidale Puro, Hydromed, Schio (Vicenza-Italy)), twice a day for two weeks.
Control group: Sterile physiological solution (NaCl 0.9%) is used as control substance. The patients are instructed to carefully rub the affected area(s) twice a day for four weeks with a sterile gauze soaked with sterile NaCl 0.9%.
Participants in both groups are follow up after one and three months.
Neomercurocromo, Colloidal silver.
Primary outcome measures
Lichen Sclerosus (LS) is measured using the LS specific scale at baseline, 1 and 3 months.
Secondary outcome measures
1. Quality of life is measured using the Dermatology Life Quality Index (DLQI)2 at baseline, 1 and 3 months
2. Patient impression of improvement is measured using the Patient Global Impression of Improvement (PGI-I) scale at baseline, 1 and 3 months
Overall trial start date
Overall trial end date
Participant inclusion criteria
2. Aged 18-70 years
3. Referred with a history of lichen sclerosus (LS) of genitalia
Target number of participants
Minimum of 40 patients in each study arm
Participant exclusion criteria
1. HIV infection
2. Any previous treatment for lichen
3. Any other present or past dermatologic disease of male genitalia
4. Penile or scrotal surgery or peircings
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
via tranquillo cremona 8
via Tranquillo Cremona 8
+39 051 442094
Investigators initiated and funded
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal. Short communications to national and international congressess have been planned as well.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Giorgio Cavallini MD (firstname.lastname@example.org)
Intention to publish date
Participant level data
Available on request
Results - basic reporting