Anti-itch effectiveness of a new cream containing emollient and moisturizing components
| ISRCTN | ISRCTN86956166 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86956166 |
| Secondary identifying numbers | POLCALM2/2020 |
- Submission date
- 07/10/2020
- Registration date
- 08/10/2020
- Last edited
- 15/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
Chronic nodular prurigo (CNPG) is a skin disease characterized by itchy papules and nodules that is usually resistant to standard treatment and associated with markedly reduced quality of life. Chronic itching is the most relevant clinical feature of this condition. The aim of this study is to evaluate the effectiveness of a cosmetic cream containing emollient lipids and three different anti-itching components in patients with CNPG.
Who can participate?
Patients aged 60 or over with CNPG
What does the study involve?
The trial will involve 2 weeks of treatment with a total of three visits (at the start and after 1 and after 2 weeks). There is no follow up. Each participant will be instructed to apply 1.5 g of the cream to the forearm (both sides) twice daily (morning and evening). Itch intensity is evaluated before and after 2 weeks' treatment using questionnaires.
What are the possible benefits and risks of participating?
The potential benefit of the study is finding an effective topical treatment able to reduce the intensity of itch in this clinical condition. The risk is considered very low, no invasive diagnostic procedures are used.
Where is the study run from?
Tor Vergata and San Gallicano Hospitals (Italy)
When is the study starting and how long is it expected to run for?
June 2020 to November 2020
Who is funding the study?
Difa Cooper (Italy)
Who is the main contact?
Massimo Milani MD
massimo.milani@difacooper.com
Contact information
Public
Via Milano 160
Caronno Pertusella
21042
Italy
| Phone | +39 (0)29659031 |
|---|---|
| massimo.milani@difacooper.com |
Study information
| Study design | Interventional prospective investigator-blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant informtion sheet |
| Scientific title | Efficacy of an omental lipid cream with specific anti-itching substances in prurigo nodularis patients |
| Study hypothesis | Prurigo nodularis is a common skin condition characterized by intense chronic itching and scratching representing a therapeutic challenge. A new emollient and moisturizing cream contains omental lipids and three components acting on different mechanisms involved in itch pathogenesis (Stimu-Tex, Polidocanol and palmitoylethanolamide). The study hypothesis is to evaluate the anti-itching efficacy of this new cream evaluated by a specific tool (VAS, Pruritus questionnaire). |
| Ethics approval(s) | The evaluated product is a marketed cosmetic not requiring specific ethics approval. Nevertheless, the trial is conducted according to GCP and the Helsinki Declaration. All subjects will provide written informed consent prior to participation. |
| Condition | Prurigo nodularis |
| Intervention | The tested product is a cream containing purified omental lipid, polidocanol, PEA (palmitoylethanolamide). The trial will involve 2 weeks of treatment with a total of three visits (at baseline and after 1 and after 2 weeks). There is no follow up. Each participating subject will be instructed to apply the tested cream on the forearm (both sides) twice daily (morning and evening) using a dose of 3 Finger Tip Units for application (1.5 g of cream each application). |
| Intervention type | Other |
| Primary outcome measure | Evolution of itch sensation at baseline and week 2 using: 1. Pruritus Visual Analogue Scale (0-100 mm) (P-VAS), a mono-dimensional scale for assessment of itch intensity 2. Numerical Rating Scale (NRS) from 1 to 10 |
| Secondary outcome measures | 1. Grade of acanthosis measured using Optical Coherence Tomography (Vivascope UK) device at baseline and week 2 2. Hyperkeratosis measured using Optical Coherence Tomography (Vivascope UK) device at baseline and week 2 3. Vascular signal measured using Optical Coherence Tomography (Vivascope UK) device at baseline and week 2 |
| Overall study start date | 01/06/2020 |
| Overall study end date | 30/11/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 30 |
| Participant inclusion criteria | 1. Age over 60 years 2. Men and women 3. Clinical diagnosis of prurigo nodularis affecting at least both arms |
| Participant exclusion criteria | 1. Acute or chronic skin conditions characterized by itching (with the exclusion of prurigo nodularis) 2. Medical internal conditions characterized by chronic itching (renal insufficiency, chronic liver disease, haematological conditions like lymphoma, polycythemia etc) |
| Recruitment start date | 15/10/2020 |
| Recruitment end date | 02/11/2020 |
Locations
Countries of recruitment
- Italy
Study participating centres
Rome
00100
Italy
Rome
0144
Italy
Sponsor information
Industry
Via Milano 160
Caronno Pertusella
21042
Italy
| Phone | +39 (0)29659031 |
|---|---|
| massimo.milani@difacooper.com | |
| Website | http://www.difacooper.com/ |
"ROR" |
https://ror.org/044sr7e96 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/05/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of this trial will be collected and analysed in order to produce a manuscript to be sent to a peer-reviewed scientific journal. All the study documentation is stored at the participating center and could be available on request. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Massimo Milani MD (massimo.milani@difacooper.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/12/2020 | 15/03/2022 | Yes | No |
Editorial Notes
15/03/2022: Publication reference added.
04/11/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 15/11/2020 to 02/11/2020.
2. The total final enrolment was added.
08/10/2020: Trial's existence confirmed by Difa Cooper (Italy).
