French nutricosmetics specialist Laboratoires Innéov has had a submission linking its proprietary blend with improved skin health turned down by the European Food Safety Authority (EFSA) health claims panel.
In its article 13.5 emerging and proprietary science dossier, Innéov included reference to 29 scientific publications, all but three of which EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) said were irrelevant to the proposed claim.
Many were deemed of no scientific import to the claim in question because the trials were conducted on individual components of the Innéov blend, and not the whole blend which contained blackcurrant seed oil, fish oil, lycopene, vitamin C, and vitamin E.
Innéov – a joint venture between L’Oreal and Nestlé – submitted the claim ‘Helps to improve dry skin condition.’
It also submitted alternative wordings:
- Helps to improve skin dryness.
- Helps to improve dry skin aspect.
- Helps to improve skin comfort.
- Helps to improve skin soothing.
- Helps to improve skin ageing signs.
- Helps to act against skin dryness.
Of the three trials deemed relevant, the NDA detailed two proprietary, unpublished human, clinical trials which it concluded, “did not result in a significant improvement in skin dryness”, including a pilot study that included a targeted sub-group of 40 elderly nuns.
This study (Humbert) ran for 84 days with some end-points showing improvement but not the major clinically evaluated endpoint – overall dryness score.
Changes between the control and active group were detected in roughness parameter, pseudo-roughness parameter and volume parameter, the panel noted, but the only significant difference was in ceramide concentration. It involved 80 50-80 year-old menopausal women with dry skin, including the 40 nuns divide between control and active groups.
‘Papery appearance on the legs’ and ‘itching after morning washing’ showed a significant change between the control and active groups.
The NDA stated: “The Panel considers that the lack of effect on the clinically evaluated outcome (dryness score) and on almost all of the many other outcomes measured indicates that the intake of a combination of blackcurrant seed oil, fish oil, lycopene, and vitamins C and E did not result in improvement in skin dryness in this study.”
The Humbert study was a pilot for the other featured study (Campagne) in the opinion that can be found here , with the NDA drawing similar conclusions.
The 30-week study featured 155 40-60 year old women with dry skin, 42 per cent of whom were menopausal, with Humbert data being used for power calculations.
This study employed the Global Skin Score (GSS) which evaluates dryness, roughness, pavement-like structures, squamous aspect, and papyraceous structure assessed on the face, hands, fore-arms and legs.
Data was taken over two 15 week periods – in summer and winter and medium chain triacylglycerides capric and caprylic acids (1.84 g per day) were used as placebo.
Innéov’s softgel blend contained blackcurrant seed oil (920mg), fish oil (920mg), lycopene (2mg), vitamin C (60mg), and vitamin E (10mg).