Condition category
Skin and Connective Tissue Diseases
Date applied
07/10/2020
Date assigned
08/10/2020
Last edited
08/10/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Public

Primary contact

Dr Massimo Milani

ORCID ID

Contact details

Via Milano 160
Caronno Pertusella
21042
Italy
+39 (0)29659031
massimo.milani@difacooper.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

POLCALM2/2020

Study information

Scientific title

Efficacy of an omental lipid cream with specific anti-itching substances in prurigo nodularis patients

Acronym

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

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.

Study design

Interventional prospective investigator-blinded trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant informtion sheet

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

Phase

Drug names

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 trial start date

01/06/2020

Overall trial end date

30/11/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age over 60 years
2. Men and women
3. Clinical diagnosis of prurigo nodularis affecting at least both arms

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

20

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

15/11/2020

Locations

Countries of recruitment

Italy

Trial participating centre

Dermatology Clinic University Tor Vergata
Viale Oxford 80
Rome
00100
Italy

Trial participating centre

Dermatology Clinic Istituto San Gallicano
Via Elio Chianesi, 53, 00144
Rome
0144
Italy

Sponsor information

Organisation

Difa Cooper (Italy)

Sponsor details

Via Milano 160
Caronno Pertusella
21042
Italy
+39 (0)29659031
massimo.milani@difacooper.com

Sponsor type

Industry

Website

http://www.difacooper.com/

Funders

Funder type

Industry

Funder name

Difa Cooper

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
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).

Intention to publish date

01/05/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

08/10/2020: Trial's existence confirmed by Difa Cooper (Italy).