Condition category
Skin and Connective Tissue Diseases
Date applied
27/02/2020
Date assigned
04/03/2020
Last edited
03/03/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Many women suffer from dry skin or loss of skin elasticity.

The study aims to assess the moisturizing and elasticizing efficacy of Profhilo Body Cream.

Who can participate?
Healthy Caucasian women aged between 30 and 65.

What does the study involve?
Participants are asked to attend clinic visits at screening and then after 14 and 28 days of product use. During the screening/baseline visit the dermatologist informs the participants about the study procedure, risks, and benefits. Only participants giving their informed consent will be enrolled in the study. The participants will then use the Profhilo Body Cream for 28 days as directed. At each visit, skin moisturization, skin elasticity, and skin compactness are evaluated by the dermatologist. All the measurements are carried out using minimally invasive procedures. The total duration of each visit is 30 minutes. The study duration is 28 days with an intermediate check at 14 days.

What are the possible benefits and risks of participating?
The product is intended to be used by subjects wishing to hydrate/moisturize and improving the elasticity of their skin. The benefits associated with the study are an improvement of skin hydration/moisturization and improvement of skin elasticity. All of these effects are temporary.

To the best of our knowledge, the risks associated with using the product are very minimal and usually associated with individual sensitivity to one or more of the ingredients in the product formula.

Where is the study run from?
Complife Italia Srl (Italy)

When is the study starting and how long is it expected to run for?
March 2020 to April 2020

Who is funding the study?
IBSA Farmaceutici (Italy)

Who is the main contact?
Dr Vincenzo Nobile
vincenzo.nobile@complifegroup.com

Trial website

Contact information

Type

Public

Primary contact

Dr Vincenzo Nobile

ORCID ID

https://orcid.org/0000-0001-9147-302X

Contact details

Via Monsignor Angelini
21
San Martino Siccomario
27028
Italy
+39 0382 25504
vincenzo.nobile@complifegroup.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

H.E.HU.MP.NEL00.030.05.00_2020/IT0000511

Study information

Scientific title

Assessment of the moisturizing and elasticizing efficacy of Hilow Haenkenium cream in healthy women: ProMoist study

Acronym

ProMoist

Study hypothesis

What is the efficacy of the test product in improving skin moisturization and skin elasticity in healthy women with dry skin (or a skin tendency to be dry) and skin atony (mild to moderate loss of skin elasticity)?

Ethics approval

There is not an ethics committee that ruled that ethical approval was not necessary. Studies on cosmetic products are usually carried out without any approval of an ethics committee. In Europe, all cosmetic products are safe for human use according to the Cosmetic Regulation EC 1223/2009. The techniques employed in cosmetic testing, and in this study, are non-invasive to minimally invasive. The study that we will perform is carried out according to the declaration of Helsinki to take into account the research ethics related to studies involving humans.

Study design

Single-centre, open label

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

Condition

Mild-to-moderate skin atony; Skin tendency to be dry or dry skin.

Intervention

30 female subjects showing the clinical signs of dry skin and mild-to-moderate skin atony (loss of skin elasticity) are enrolled. Subjects are asked to attend clinic visits at screening/baseline and after 14 and 28 days of product use. Only subjects giving their informed consent will be enrolled in the study.

The participants will be asked to use Profhilo Body Cream on their skin (legs, thigh, gluteus, abdomen, and arms) once a day for 28 days.

At each visit, skin moisturization, skin elasticity, and skin compactness are evaluated by the dermatologist. Skin moisturization (using a Corneometer®), skin elasticity (using a Cutometer® MPA 580) and skin strippings (sampling of the outermost layers of the stratum corneum by means of Corneofix® foils) are taken at study start and after 14 and 28 days product use. All the measurements are carried out using minimally invasive procedures. The total duration of each visit is 30 minutes. The study duration is 28 days with an intermediate check at 14 days.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Skin moisturization measured using a Corneometer® at baseline, 14 and 28 days
2. Skin elasticity measured by means of Cutometer® MPA 580 at baseline, 14 and 28 days

Secondary outcome measures

Skin compactness and skin tolerability assessed by visualization of skin strippings taken with Corneofix® foils at baseline, 14 and 28 days

Overall trial start date

03/02/2020

Overall trial end date

30/04/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Healthy female subject
2. Caucasian ethnicity
3. Aged between 30 and 65 years
4. Mild to moderate skin atony
5. Skin tendency to be dry or dry skin
6. Has not been recently involved in any other similar study
7. Willingness to use during all the study period only the product to be tested
8. Willingness to not vary the normal daily routine

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

30

Participant exclusion criteria

1. Subject does not meet the inclusion criteria
2. Positive history for atopy or hypersensitive skin
3. Past history of allergy or sensitivity to cosmetics, toiletries, to solar and/or topical medications
4. Any skin condition that the principal investigator deems inappropriate for participation
5. Pregnancy or nursing women

Recruitment start date

09/03/2020

Recruitment end date

24/03/2020

Locations

Countries of recruitment

Italy

Trial participating centre

Complife Italia Srl
Via Monsignor Angelini, 21 San Martino Siccomario 27028
San Martino Siccomario
27028
Italy

Sponsor information

Organisation

IBSA Farmaceutici (Italy)

Sponsor details

Via Martiri di Cefalonia
2
Lodi
26900
Italy
+39 0371 617 1
gilberto.bellia@ibsa.it

Sponsor type

Industry

Website

https://www.ibsa.it/

Funders

Funder type

Industry

Funder name

IBSA Farmaceutici Italia S.r.l.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Study results will be disseminated in a journal dealing with cosmetic efficacy studies.

IPD Sharing statement:
Raw data will be stored in Complife servers. A backup copy of the raw data will be also in a cloud-based backup server. Tables containing the raw data (output of the measurements) will be also included in the study report and shared with the study Sponsor by a pdf file electronically signed. The raw data will be stored for a minimum period of 10 years in Complife servers. In the raw data tables, subjects are identified by a means of a code generated by the Complife volunteer’s management software. The code is composed of a letter, 4 digits, and a letter. The access to the study raw data is allowed only to the study director and the person designated by him to elaborate the raw data. Elaboration of the raw data includes descriptive statistics (mean and standard error) and the inferential analysis (data normality and statistical test).

Intention to publish date

31/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/03/2020: Trial’s existence confirmed by IBSA Farmaceutici Italia.