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Introduction
Two fields, one common misconception
Melatonin is mainly associated with the sleep-wake rhythm. In dermatological research it is also discussed in relation to skin, oxidative stress and hair follicles. PRP is discussed separately in aesthetic and dermatological practice in hair-related questions.
This article does not state that melatonin-containing tubes have a therapeutic effect, improve PRP or are suitable for treating hair loss. Such a claim would not be sufficiently supported and would be regulatory-sensitive if the product is not certified as a medical device under the MDR and is not approved as a medicinal product.
Dermatological perspective
Melatonin from a dermatological perspective
Melatonin is an endogenous indolamine. Scientific publications describe it in connection with antioxidant mechanisms, skin biology and hair follicles. This does not provide a clinical statement for specific products or preparation systems.
Hair growth and hair loss are influenced by many factors. Individual biological mechanisms are not sufficient to derive a therapeutic effect of a product.
Evidence
Evidence on melatonin and hair
The clinical literature mainly relates to topical applications applied to the scalp. Reviews report positive signals, while also pointing to methodological limitations.
The data do not relate to melatonin-containing tubes in the PRP context and must not be directly transferred to such product categories.
Synthesis
Melatonin and PRP: what can currently be said?
Melatonin
Topical melatonin has been investigated in individual studies and reviews on hair follicle biology and alopecia.
PRP
PRP has been investigated in separate studies on androgenetic alopecia.
Tubes
Melatonin-containing tubes in the PRP context must be assessed separately. Current data do not allow a reliable statement on clinical efficacy for this product category.
Transferring data from topical melatonin studies to a tube with melatonin additive would not be scientifically sound. It would also be problematic to use general PRP data as if they automatically proved the benefit of an additional ingredient.
Regulation
Intended purpose and advertising claims
Whether a product is classified as a medical device in the EU depends largely on its intended medical purpose. The intended purpose is determined in particular by the overall view of labelling, instructions for use and advertising and sales material.
Claims to avoid
effective against hair losspromotes hair growthstimulates hair folliclesimproves PRPoptimizes PRP therapysupports treatment of androgenetic alopecia
Such statements may create the impression of a therapeutic effect or a medical intended purpose and should be avoided for products that are not appropriately certified.
Conclusion
Melatonin, PRP and hair follicles are scientifically relevant fields. The literature provides indications of biological plausibility and data on topical melatonin and PRP. These data are not equivalent to proof of efficacy for melatonin-containing tubes in the PRP context.
Legally and professionally sound communication should clearly separate scientific research, professional classification and product information.
Compliance note
This article is intended for professional information and scientific classification. It does not constitute a therapy recommendation, instructions for use or a statement on the efficacy of individual products.
Borosilicate tubes with melatonin additiveNot certified as a medical device under the MDR
A corresponding technical product category with melatonin additive is listed separately as product information. The product is not certified as a medical device under the MDR and is not approved as a medicinal product. This classification does not imply any statement on therapeutic effect, improvement of PRP, safety or suitability for treatment.
References
- Fischer TW et al. Topical melatonin for treatment of androgenetic alopecia.
- Fischer TW et al. Melatonin and the hair follicle.
- Review on melatonin in hair follicle biology and alopecia research.
- Systematic reviews and meta-analyses on PRP in androgenetic alopecia.
- Regulation (EU) 2017/745 on medical devices.
- Heilmittelwerbegesetz, § 3 HWG.