Condition category
Not Applicable
Date applied
03/06/2019
Date assigned
04/06/2019
Last edited
04/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The study aimed to assess the efficacy of Profhilo Haenkenium® in improving the skin condition of subjects showing mild-to-moderate skin ageing signs and skin redness due to cold and wind

Who can participate?
Female subjects (aged between 40 and 65 years old).

What does the study involve?
Participants will use the test product on the face for the duration of the study. Skin condition will be assessed in a clinical assessment at baseline and after14, 28, 56 and 84 days product use

What are the possible benefits and risks of participating?
Benefits associated with product use and study participation are related to an improvement of skin conditions. During the study is possible that subjects would note a decrease in skin redness and wrinkles depth.
Benefits associated with product use and study participation are related to both subjective and objective adverse events (AEs) (e.g. skin irritation, sensitization, etc.). The occurrence of AEs related to individual susceptibility to specific ingredients in the product could be related to biological phenomenon that are not avoidable and cannot be considered as AEs due to product use. Potential risks are assumed to be from mild to moderate and are not expected to pose a risk to human health. Risks associated with the procedures involved in this study are judged as minor. All the measurements carried out are not invasive and/or minimally invasive and no skin side effects are expected from the measurement process.

Where is the study run from?
Complife Italia Srl, San Martino Siccomario, Italy

When is the study starting and how long is it expected to run for?
January 2017 for one month

Who is funding the study?
IBSA Farmaceutici Italia S.r.l., Italy

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vincenzo Nobile

ORCID ID

http://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

E.HU.016-0050.01.005L_2017/3939

Study information

Scientific title

Evaluation of the anti-ageing efficacy of Hilow Haenkenium cream in healthy women

Acronym

HILOW

Study hypothesis

The aim of the study is to evaluate the anti-ageing efficacy of Hilow Haenkenium cream in healthy women

Ethics approval

None required

Study design

Single-centre open label

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Other

Patient information sheet

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

Condition

Mild-to-moderate ageing skin signs and skin redness due to cold and wind

Intervention

Participants attended clinic visits at screening, baseline and after 14, 28, 56 and 84 days product use (Profhilo Haenkenium®). During the screening visit subjects were informed on study procedures, risks and benefits. Only subjects giving their informed consent were enrolled in the study. Information on the medical history of the subjects were taken only after informed consent signature and subject’s eligibility to participate in the study was checked by a board-certified dermatologist. At each visit skin elasticity, wrinkle depth and skin redness are measured using non-invasive bioengineering techniques; while skin strippings (trough the stratum corneum, superficial layer of the skin) were taken using minimally invasive adhesive foils. The total duration of each visit was 30 minutes. The total study duration was 84 days.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Antiageing efficacy is measured by means of wrinkle depth and total skin antioxidant capacity using Ferric Reducing Antioxidant Power (FRAP) assay at baseline, and after 14, 28, 56 and 84 days of product use.

Secondary outcome measures

Skin redness and skin elasticity/compactness assessed using clinical assessment carried out by the dermatologist and the self-assessment carried out by the subjects participating in the study at baseline, and after 14, 28, 56 and 84 days of product use.

Overall trial start date

04/12/2016

Overall trial end date

31/05/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Healthy female subject
2. Caucasian ethnicity
3. Age between 40 and 65 years old
4. Subjects showing mild to moderate ageing skin signs and skin redness due to cold and wind
5. Subjects who have not been recently involved in any other similar study
6. Willingness to use during all the study period only the product to be tested
7. Willingness to not vary the normal daily routine

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

50

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

09/01/2017

Recruitment end date

31/01/2017

Locations

Countries of recruitment

Italy

Trial participating centre

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

Sponsor information

Organisation

IBSA Farmaceutici Italia S.r.l.

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

Planned publication in BioMed Research International in 2019

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date

01/07/2019

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

04/06/2019: Trial’s existence confirmed by Complife Group.