Neomercurocromo and colloidal silver for penile lichen sclerosus
| ISRCTN | ISRCTN27941065 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27941065 |
| Secondary identifying numbers | 2017/1 |
- Submission date
- 04/06/2017
- Registration date
- 23/06/2017
- Last edited
- 19/01/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
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)
Contact information
Scientific
Gynepro Medical
via Tranquillo Cremona 8
Bologna
40137
Italy
Public
Gynepro Medical
via Tranquillo Cremona 8
Bologna
40137
Italy
 ORCID ID |
0000-0002-1673-3482 |
|---|
Study information
| Study design | Randomised placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use te contact details below to request a participant information sheet. |
| Scientific title | 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 |
| Study acronym | ELST |
| Study hypothesis | 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. |
| Ethics approval(s) | Gynepro Ethics Board, 10/05/2017, ref: CdB 01/2017 |
| Condition | Lichen sclerosus of male genitalia |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Neomercurocromo, Colloidal silver. |
| Primary outcome measure | 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 study start date | 23/03/2017 |
| Overall study end date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Male |
| Target number of participants | Minimum of 40 patients in each study arm |
| Participant inclusion criteria | 1. Male 2. Aged 18-70 years 3. Referred with a history of lichen sclerosus (LS) of genitalia |
| 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 | 16/05/2017 |
| Recruitment end date | 31/03/2018 |
Locations
Countries of recruitment
- Italy
Study participating centre
Bologna
40137
Italy
Sponsor information
Hospital/treatment centre
via Tranquillo Cremona 8
Bologna
40137
Italy
| Phone | +39 051 442094 |
|---|---|
| info@ginepro.it | |
"ROR" |
https://ror.org/03segdh23 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Giorgio Cavallini MD (giorgiocavallini@libero.it) |
Editorial Notes
19/01/2018: The recruitment end date has been updated from 31/12/2017 to 31/03/2018.
