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Use of melatonin, oral and cream, to counteract skin ageing: a controlled trial

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN58661770
Enrollment
50
Registered
2025-01-21
Start date
2023-09-01
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin ageing Skin and Connective Tissue Diseases

Interventions

"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 twi

Sponsors

Difa Cooper (Italy)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women with moderate/severe skin ageing defined as a Glogau Score higher than II

Exclusion criteria

Exclusion criteria: Skin acute conditions like eczema or skin cancer

Design outcomes

Primary

MeasureTime frame
Elasticity, wrinkles, roughness, pigmentation, erythema, and skin pores assessed using the Skin Aging Global Score (SAGS) at baseline, week 6 and week 12

Secondary

MeasureTime frame
1. Clinical evaluation of Skin ageing using the Glogau score at baseline, week 6 and week 12 2. Single parameters of SAGS measured at baseline, week 6 and week 12 3. Instrumental skin ageing evaluation using VISIA objective face sculptor analysis performed on a subgroup of 20 participants at baseline, week 6 and week 12

Countries

Italy

Contacts

Public ContactMassimo Milani
massimo.milani@difacooper.com+39 (0)29659031

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026