Vitiligo is a disease with an estimated worldwide prevalence of between 0.06% and 2.28%.1 Very often, the appearance of characteristic achromic lesions has a marked psychological effect, to the extent that patients end up trying various treatments with the aim of repigmenting the lesions.2,3 A new class I topical health care product—Pigmerise 20% in Fitalite—was recently marketed for the treatment of vitiligo.

We report 3 clinical cases of patients with vitiligo and allergic contact dermatitis to this new product. The patients (2 women, 1 man; age, 37-51 years) had had vitiligo for several years and had received topical treatment with corticosteroids, tacrolimus 0.1%, and/or narrowband UV-B therapy. They all experienced a local eczematous reaction at the site of application between 3 weeks and 2 months after first use. The use test with the commercial product yielded a positive result in all 3 cases. The patients subsequently underwent patch testing with the standard series of the Spanish Contact Dermatitis and Skin Allergy Research Group (GEIDAC) and with the 2 components of the product: the active ingredient, Pigmerise, diluted to 1% and 0.4% in white petrolatum; and its vehicle, the hydrophilic gel cream Fitalite. Both components were supplied by the company sales representative. In all 3 cases, the results were positive at 48hours and at 96hours with the black pepper extract at both concentrations (Pigmerise, 0.4% and 1%) and negative with Fitalite (Fig. 1). Test results were positive for 2 of the patients with the Spanish standard series, albeit without present relevance (Table 1). Furthermore, patient 2 experienced a reactivation phenomenon during the patch tests, with the appearance of eczematous plaques on the antecubital skinfolds and axilla, where the product had been applied. Patch testing with 25 healthy controls yielded negative results.

Figure 1.

Results of Allergic Contact Tests for Patients 1 and 3 at 96h for Pigmerise 0.4 and 1%.

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The use of plant-derived products for both cosmetic and medicinal purposes has increased considerably in recent years. Evidence from clinical trials on the safety and efficacy profile of these products before marketing is generally lacking. The use of plant-derived products is not free of risks, and topical application can cause various types of local reaction, the main ones being irritant contact dermatitis, allergic contact dermatitis, contact urticaria, photoaggravated eczema, and phototoxic reactions.4 The recently marketed Pigmerise 20% in Fitalite for treatment of vitiligo contains an active ingredient composed of a natural phytocomplex of liquid oleoresin derived from black pepper extract (Piper nigrum L or piperine). This is formulated at 20% in a hydrophilic gel cream with high concentrations of triglycerides of linoleic and oleic acid known as Fitalite. The compound is thought to act by activating proliferation of melanocytes, as previously shown in vitro.5 However, we were unable to find articles or other publications with safety and efficacy data for this product: since it is marketed as a class I product, pharmacovigilance studies are not necessary.

The literature to date does not contain published cases of allergic contact dermatitis caused by black pepper extract (piperine); therefore, the 3 cases we report are the first cases of allergic contact dermatitis to Pigmerise. The cases highlight the need to establish strict epidemiological vigilance, in which the dermatologist plays a key role by identifying such reactions, especially those associated with topical products, and reports confirmed cases to the Spanish Agency of Medicines and Medical Devices.