Efficacy and tolerability of a topical skin-lightening cosmetic product combination on facial dyspigmentation compared with 4% hydroquinone
| ISRCTN | ISRCTN33310512 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33310512 |
| Secondary identifying numbers | 17E3927 |
- Submission date
- 10/12/2018
- Registration date
- 30/01/2019
- Last edited
- 19/02/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
Melasma is a common pigmentation disorder characterized by the presence of large irregular brown macules areas in the sun-exposed skin areas, particularly the face and the neck. Hydroquinone is a drug component that has long been the gold standard for the treatment of melasma but its use is compromised due to long-term risks of skin damage. A new skin-lightening combination of cosmetic products (CCP) targeting various steps of the skin pigmentation pathway has been developed. This study aims to evaluate the effectiveness and tolerability of the new CCP compared to hydroquinone 4% in the treatment of facial dyspigmentation.
Who can participate?
Women or men aged between 18 and 60 with a skin phototype IV-V and facial dyspigmentation due to melasma
What does the study involve?
Subjects are randomly allocated to apply on the face, neck and neckline either the combination of cosmetic products (CCP) or 4% hydroquinone cream daily for 12 weeks. The skin is evaluated at the start of the study, week 6 and week 12.
What are the possible benefits and risks of participating?
The study is carried out with cosmetic products whose safety has been assured by the Sponsor. Its aim is to further confirm, under normal and reasonably foreseeable use conditions, the capacity of products to maintain the human body in a good condition and reduce the pigmentation of spots.
Where is the study run from?
Insight Research, a clinical trial organization in Mauritius
When is the study starting and how long is it expected to run for?
January 2018 to May 2018
Who is funding the study?
Isispharma, the company that manufactured the skin-lightening cosmetic product combination
Who is the main contact?
Amélie Clement
Contact information
Scientific
ISISPHARMA
29 rue Maurice Flandin
Immeuble le Forum 1er Etage
Lyon
69003
France
Study information
| Study design | Single-centre double-blinded parallel-group randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Efficacy and tolerability of a topical skin-lightening CPP on subjects presenting facial dyspigmentation compared with 4% hydroquinone |
| Study acronym | CCP: combination of cosmetic products |
| Study hypothesis | The synergetic action of this new topical product combination containing natural extracts and targeting different signaling pathways in melanogenesis could offer an effective and safer alternative to hydroquinone in the management of facial dyspigmentation. |
| Ethics approval(s) | The Clinical Trials Act 2011 governing clinical trials in Mauritius is not applicable in the case of this study and therefore does not require the authorization of the Competent Authority. However, the study received the approbation of a private and independent ethics committee on 30/01/2018 |
| Condition | Mild to moderate facial dyspigmentation due to melasma, but otherwise healthy skin |
| Intervention | Subjects are randomly assigned to one of the two treatment groups. In the intervention group (CCP group), subjects receive the combination of cosmetic products (CCP): Neotone® serum once daily in the evening and Neotone® Radiance SPF 50+ once daily in the morning. In the control group (HQ group), subjects receive 4% hydroquinone cream once daily in the evening and an SPF 50+ cream once daily in the morning. In addition, all the subjects are advised to use a sunscreen without any skin-lightening components, twice daily. All the subjects are instructed to apply the products from baseline for a period of 12 weeks and as recommended by the manufacturer on the face, neck and neckline, avoiding eye area. Evaluation of the two treatments modalities are performed at baseline, week 6 and week 12 for the following parameters: clinical examination, M-MASI score, colorimetric assessment, facial imaging, tolerability assessment, self-assessment questionnaire. |
| Intervention type | Other |
| Primary outcome measure | 1. Clinical scoring of the dyspigmentation with the Modified-MASI score (M-MASI; Dr Amit PANDYA) is performed at baseline, week 6 and week 12 2. Cutaneous color assessed using the Spectrocolorimeter® at baseline, week 6 and week 12 3. Expected visual effect is assessed with photographs taken at baseline, week 6 and week 12 4. Cutaneous acceptability assessed by clinical examination under dermatological control at baseline, week 6 and week 12 5. Cosmetic acceptability and future use is assessed by analysis of the subjects’ answers to a subjective evaluation questionnaire at week 6 and week 12 |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 09/01/2018 |
| Overall study end date | 31/05/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 44 subjects (22 in each cluster) |
| Total final enrolment | 43 |
| Participant inclusion criteria | 1. Women or men 2. Aged between 18 and 60 years 3. Skin phototype IV-V 4. Presenting facial dyspigmentation due to melasma as determined by Wood’s light examination |
| Participant exclusion criteria | 1. Pregnant or nursing women or women planning to get pregnant during the study 2. Subjects with a cutaneous pathology on the study zone (eczema) 3. Subjects having undergone surgery under general anaesthesia within the previous month 4. Individuals who have been excessively exposed to sunlight or UV-rays within the previous month 5. Subjects having used topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous acceptability of the study product |
| Recruitment start date | 22/01/2018 |
| Recruitment end date | 19/02/2018 |
Locations
Countries of recruitment
- Mauritius
Study participating centre
St Jean Road
Quatre Bornes
-
Mauritius
Sponsor information
Industry
29 rue Maurice Flandin
Immeuble le Forum 1er Etage
Lyon
69003
France
| Website | http://www.isispharma.com |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/01/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The study is planned to be published in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Anne Sirvent (ASI@dermscan.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2020 | 19/02/2020 | Yes | No |
Editorial Notes
19/02/2020: Publication reference and total final enrolment number added.
18/09/2019: The intention to publish date was changed from 08/01/2019 to 01/01/2020.
