Use of melatonin, oral and cream, to counteract skin ageing: a controlled trial
| ISRCTN | ISRCTN58661770 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58661770 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Difa Cooper (Italy) |
| Funder | Difa Cooper |
- Submission date
- 20/01/2025
- Registration date
- 21/01/2025
- Last edited
- 21/01/2025
- 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
Skin ageing is a complex process influenced by intrinsic factors, such as genetic predisposition, and extrinsic factors, including UV radiation and environmental pollution. Melatonin, a hormone known for its role in regulating circadian rhythms, has gained attention in dermatology for its potential anti-ageing properties due to its antioxidant and skin-repairing effects. Topical melatonin-based treatments have shown promise in improving signs of skin ageing, including elasticity, wrinkles, and pigmentation. However, no clinical studies have evaluated the combined ("In&Out") approach of using a topical melatonin-based cream alongside a melatonin-containing oral supplement enriched with hyaluronic acid and apigenin, both of which are recognized for their anti-ageing and skin hydration properties. Understanding the synergistic potential of this regimen could offer new insights into more comprehensive anti-ageing strategies.
This study aims to compare the effectiveness of two skin anti-ageing strategies: the use of a melatonin-based topical cream alone and a combined regimen of the same melatonin-based cream and a melatonin-based oral supplement containing hyaluronic acid and apigenin. The primary objective is to assess changes in skin ageing signs over a 12-week period. Secondary objectives include evaluating specific skin parameters and conducting VISIA imaging analysis to further explore the potential added benefit of the combination therapy compared to topical treatment alone.
Who can participate?
People aged over 50 years with moderate-severe skin ageing (Glogau score >2)
What does the study involve?
The study involved two melatonin-based products, one melatonin-based cream and a food supplement containing melatonin, apigenin and hyaluronic acid. Participants were randomly allocated to one of two groups. They were instructed to apply the cream twice a day for group A, and the cream twice per day plus one tablet of the food supplement per day for group B. The total duration of the treatment was 12 weeks with three measurements at the start and after 6 and 12 weeks.
What are the possible benefits and risks of participating?
The possible benefit is the improvement of skin health and skin ageing. There are no risks because of the use of already approved cosmetic products using well-known ingredients.
Where is the study run from?
Difa Cooper (Italy)
When is the study starting and how long is it expected to run for?
June 2023 to April 2024
Who is funding the study?
The study was founded by an unrestricted grant from Cantabria Labs Difa Cooper (Italy)
Who is the main contact?
Dr Massimo Milani, massimo.milani@difacooper.com
Contact information
Public, Scientific, Principal investigator
Via Milano 160
Caronno Pertusella
21042
Italy
 ORCID ID |
0000-0001-7559-1202 |
|---|---|
| Phone | +39 (0)29659031 |
| massimo.milani@difacooper.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized prospective assessor-blinded interventional trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Skin anti-aging effect of a melatonin-based in&out strategy in comparison with topical treatment alone: a randomized, assessor-blinded, prospective trial with VISIA evaluation |
| Study objectives | To evaluate if an "In&Out" strategy with a melatonin-based dietary supplementation plus melatonin cream-based treatment was superior to melatonin-based cream only on skin aging. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | The present trial was performed using a cosmetic and a food supplement. Therefore according to the current national legislation, a formal EC approval is not required. However, the present trial was performed according to Helsinki's ethical principles. Each subject signed an informed consent. |
| Health condition(s) or problem(s) studied | Skin ageing |
| Intervention | "Out" strategy: Melatonin-based cream 0.1% "In" strategy: Mel-based (0.5 mg) dietary supplementation also containing hyaluronic acid (150 mg; HA) and apigenin (0.9 mg) Participants were randomized in a 1:1 allocation ratio. They were also instructed to apply the cream twice a day using 2 ftu (fingertips units) for group A and the cream twice per day using 2 ftu plus one tablet of the food supplement per day for group B. The total duration of the treatment was 12 weeks with three measurements (baseline, t6 and t12) and two timepoints at 6 and at 12 weeks. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Elasticity, wrinkles, roughness, pigmentation, erythema, and skin pores assessed using the Skin Aging Global Score (SAGS) at baseline, week 6 and week 12 |
| Key secondary outcome measure(s) |
1. Clinical evaluation of Skin ageing using the Glogau score at baseline, week 6 and week 12 |
| Completion date | 01/04/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Lower age limit | 50 Years |
| Upper age limit | 70 Years |
| Sex | Female |
| Target sample size at registration | 50 |
| Total final enrolment | 46 |
| Key inclusion criteria | Women with moderate/severe skin ageing defined as a Glogau Score higher than II |
| Key exclusion criteria | Skin acute conditions like eczema or skin cancer |
| Date of first enrolment | 01/09/2023 |
| Date of final enrolment | 01/02/2024 |
Locations
Countries of recruitment
- Italy
Study participating centres
Caronno Pertusella
21042
Italy
Modena
41124
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Dataset will be available on request from Dr Massimo Milani (massimo.milani@difacooper.com) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/01/2025: Study's existence confirmed by Difa Cooper (Italy).
