Whitening efficacy of a food supplement
| ISRCTN | ISRCTN12882379 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12882379 |
| Secondary identifying numbers | H.E.HU.HV.NWH00.060.41.00_NT0000092/23 |
- Submission date
- 21/05/2023
- Registration date
- 20/07/2023
- Last edited
- 20/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
The active food supplement intervention is a phytocomplex extracted from licorice (Glycyrrhiza Glabra) which is traditionally known for its efficient brightening activity. The study aims to assess the skin whitening efficacy of the food supplement on a multi-ethnic panel after 28 and 56 days of oral intake.
Who can participate?
Male and female subjects (multiethnic panel) aged from 25 to 65 years old showing skin spots related to age, sun exposure or post-inflammatory hyperpigmentation.
What does the study involve?
Participants are asked to attend clinic visits at screening and after 28 and 56 days of food supplement intake and cosmetic product use. During the screening visit, the principal investigator will inform the participants about the trial procedure, risks, and benefits. Only participants giving their informed consent are enrolled in the study. The trial staff and the subjects then fix the date for the first visit. During the first visit, the subjects will answer all the questions on the medical questionnaires given by the principal investigator. The participants are then randomly allocated to use the active food supplement or the placebo products for 56 days.
According to a randomization list subjects will be divided into two study groups:
1. 30 subjects take the active food supplement
2. 30 subjects take the placebo food supplement
Each group includes:
10 Caucasian subjects (volunteers recruited in Italy)
15 Chinese subjects (volunteers recruited in China)
5 Asian ethnicity with phototype IV-V (volunteers recruited in Italy)
To standardize the volunteer’s cosmetic habits, a base face cream with SPF without any cosmetic activity is provided to the subjects for use during the whole study period instead of their usual day/night face cream. All the measurements/assessments are carried out using non-invasive procedures. The total duration of each visit is 30 minutes. The study duration is 56 days with one intermediate check at 28 days.
What are the possible benefits and risks of participating?
The potential benefits associated with the product use are amelioration of skin conditions such as brown spots (related to age, sun exposure or post-inflammatory hyperpigmentation). In particular, improvements in face skin radiance/brightness, spots, skin pigmentation and skin complexion are expected.
Risks associated with the procedures involved in this study are judged as minor. All precautions will be taken to ensure that the risk is the lowest possible. All the measurements carried out are minimally invasive and no side effects are expected from the measurement process. Due to the nature of the active ingredient volunteers blood pressure is monitored during the whole study period.
Where is the study run from?
1. Nutratech srl spin-off Università della Calabria (Italy)
2. Complife Beijing Testing Technology Co., Ltd (China)
When is the study starting and how long is it expected to run for?
February 2023 to August 2023
Who is funding the study?
ROELMI HPC Srl (Italy)
Who is the main contact?
Mrs Ileana De Ponti, ileana.deponti@complifegroup.com
Contact information
Principal Investigator
Master’s Degree in Chemist and Pharmaceutical Technologies
Via Guido Rossa 1
Garbagnate Milanese
20024
Italy
 ORCID ID |
0000-0003-0579-7904 |
|---|---|
| Phone | +39 3316841438 |
| ileana.deponti@complifegroup.com |
Scientific
Master’s Degree in Chemist and Pharmaceutical Technologies
Via Guido Rossa 1
Garbagnate Milanese
20024
Italy
| Phone | +39 3316841438 |
|---|---|
| ileana.deponti@complifegroup.com |
Public
Master’s Degree in Chemist and Pharmaceutical Technologies
Via Guido Rossa 1
Garbagnate Milanese
20024
Italy
| Phone | +39 3316841438 |
|---|---|
| ileana.deponti@complifegroup.com |
Study information
| Study design | Multicenter stratified randomized double-blind placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A clinical trial aimed to evaluate the whitening efficacy of a dietary supplement in healthy adults. Multi-ethnic panel. Double-blind controlled study versus placebo |
| Study acronym | WhiteMulthiEthnic |
| Study objectives | Oral intake of a food supplement will show skin whitening efficacy, whitening brown spots (related to age, sun exposure or post-inflammatory hyperpigmentation). In particular, it will have an effect on face skin radiance/brightness, spots and skin pigmentation, skin evenness complexion and whitening efficacy. |
| Ethics approval(s) |
Approved 09/03/2023, Independent ethics committee for non-pharmacological clinical investigations (Via XX Settembre 30/4, Genova, 16121, Italy; +39 (0)10 5454842; ssinf@messaggipec.it), ref: 2023/02 |
| Health condition(s) or problem(s) studied | Presence of skin spots related to age, sun exposure or post-inflammatory hyperpigmentation |
| Intervention | The study aims to assess the skin whitening efficacy of a food supplement on a multi-ethnic panel of 60 subjects after 28 and 56 days of intake. The aim of this study is to evaluate the efficacy of the product supplementation on whitening brown spots (related to age, sun exposure or post-inflammatory hyperpigmentation). In particular, face skin radiance/brightness, spots and skin pigmentation, skin evenness complexion and whitening efficacy are evaluated. Moreover, the measurement of the variation of the levels of accumulated advanced glycation end products (AGE) in the skin, product tolerability evaluation and volunteers' perceived efficacy by self-assessment questionnaire are evaluated. The active food supplement intervention is a phytocomplex extracted from licorice (Glycyrrhiza Glabra) which is traditionally known for its efficient brightening activity (ROELMI HPC, Via Celeste Milani, 24/26, 21040 Origgio (VA), Italy); while the placebo food supplement intervention is: charcoal, maltodextrin and magnesium stearate. Both the active and the placebo products are used as follows: one capsule per day to be taken on an empty stomach with a glass of still water for 56 days. To standardize the volunteer’s cosmetic habits, a base face cream with SPF without any cosmetic activity is provided for use during the whole study period instead of their usual day/night face cream. Test subjects are randomized into two groups of 30 subjects as follows: one group takes the active food supplement and one group takes the placebo food supplement, Each group includes: - 10 Caucasian subjects (volunteers recruited in Italy) - 15 Chinese subjects (volunteers recruited in China) - 5 Asian ethnicity with phototype IV-V (volunteers recruited in Italy). A restricted randomization list is created using PASS 2008 (PASS, LLC. Kaysville, UT, USA) statistical software running on Windows Server 2008 R2 Standard SP1 64-bit Edition (Microsoft, USA) by a biostatistician and stored in a safe place. The randomization sequence was stratified using “Efron’s biased coin” algorithm with a 1:1 allocation ratio. The allocation sequence was concealed from the in-site study director in sequentially numbered, opaque and sealed envelopes, reporting the unblinded treatment allocation (based on the subject entry number in the study). The A4 sheet reporting the unblinded treatment was folded to render the envelope impermeable to intense light. A masked allocation sequence was prepared for the staff delivering the intervention based on the subject entry number in the study. |
| Intervention type | Supplement |
| Primary outcome measure | The whitening efficacy of the tested treatment will be evaluated by: 1. Evaluation of spots and skin individual typology angle (ITA) measured using a spectrophotometer/colorimeter CM-700D (Konica-Minolta) at T0, T28, and T56 (days) 2. Evaluation of skin radiance/skin brightness measured using a spectrophotometer/colorimeter CM-700D (Konica-Minolta) at T0, T28, and T56 3. Clinical evaluation of skin evenness complexion and whitening efficacy on Visia pictures measured using an improvement clinical scale (from 1: no variation to 4: remarkable improvement) at T28 and T56 |
| Secondary outcome measures | 1. Measurement of the variation of the levels of accumulated advanced glycation end products (AGE) measured using an AGE Reader mu of DiagnOptics Technologies B.V at T0 and T56 2. An evaluation of face digital pictures measured using means of Visia®-CR (Canfield Scientific) at T0, T28, T56 3. Product acceptability and volunteers’ perceived efficacy measured using a self-assessment questionnaire at T28 and T56 |
| Overall study start date | 03/02/2023 |
| Completion date | 31/08/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 66 |
| Key inclusion criteria | 1. Healthy female and male subjects 2. Age between 25 and 65 (extremes included) years old 3. Multi-ethnic panel 4. Subjects showing skin spots related to age, sun exposure or post-inflammatory hyperpigmentation 5. Subjects who have not been recently involved in any other similar study (at least one month of wash-out) 6. Willingness to not use during the study period products other than the test product 7. Willingness to not vary the normal diet and daily routine (at the beginning of the study volunteers will list their usual routine: sports activities, sleeping habits, etc.) 8. Subject is under effective contraception (oral/not oral) therapy 9. Subjects who accept not to expose in an intensive way to UV rays during the whole study duration 10. Subjects registered with Nation Health Service (NHS) 11. Subjects certifying the truthfulness of the personal data disclosed to the investigator 12. Subjects able to understand the language used in the investigation center and the information given by the investigator 13. Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements 14. The pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) should be stable for at least one month without any changes expected or planned during the study 15. Subjects having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization |
| Key exclusion criteria | 1. Subject does not meet the inclusion criteria 2. Subjects with acute or chronic diseases able to interfere with the outcome of the study or that are considered dangerous for the subject or incompatible with the study requirements 3. Subjects participating or planning to participate in other clinical trials 4. Subjects not able to be contacted in case of emergency 5. Subjects admitted to a health or social facility 6. Subjects planning a hospitalization during the study 7. Subjects who participated in a similar study without respecting an adequate washout period (at least one month of wash-out) 8. Subject with known or suspected sensitization to one or more test formulation ingredients 9. Having a diagnosed chronic disease (blood, cardio-vascular, psychiatric, neuro-degenerative, cancer, liver, gastric, skin, etc.) and/or under medical treatment; in particular subjects suffering from hypertension, renal insufficiency, liver cirrhosis and diabetes will be excluded from the trial 10. Consumption of food supplement(s) and/or use of topical skincare products with whitening activity currently or within the past 4 weeks before the study: moreover the assumption of foods containing liquorice is not recommended for the entire duration of the study 11. Adult protected by the law (under guardianship, or hospitalized in a public or private institution, for a reason other than the research, or incarcerated) 12. Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function 13. Subjects accustomed to using tanning beds 14. Subjects taking medication with photosensitizing potential, drugs and/or dietary supplements able to induce skin coloring, corticoids, currently or during the month before the study 15. Subjects under pharmacological treatments that are considered incompatible with the study requirements by the investigator 16. Subjects having a skin disease or condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements 17. Subjects that have shown allergies or sensitivity to cosmetic products, drugs, patches or medical devices 18. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential) |
| Date of first enrolment | 03/04/2023 |
| Date of final enrolment | 05/07/2023 |
Locations
Countries of recruitment
- China
- Italy
Study participating centres
Rende
87036
Italy
Beijing
100089
China
Sponsor information
Industry
Via Celeste Milani
24 / 26
Origgio
21040
Italy
| Phone | +39 (0)2 3351 0150 |
|---|---|
| info@roelmihpc.com | |
| Website | https://www.roelmihpc.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/05/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-review journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository on Complife/Nutratech 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 in a pdf file that is electronically signed. The raw data will be stored for a minimum period of 10 years on Complife servers. In the raw data tables, subjects are identified by means of a code generated by the Complife volunteer’s management software. The code is composed of a letter, four digits, and a letter. Access to the study's raw data is allowed only by the study director and the person designated by him to elaborate on the raw data. Elaboration of the raw data includes descriptive statistics (mean and standard error) and inferential analysis (data normality and statistical test). |
Editorial Notes
17/07/2023: Trial's existence confirmed by Independent Ethics Committee for Non-Pharmacological Clinical Investigations of the Italian Scientific Society for Non-pharmacological Clinical Investigations (Italy).
