Seal of Acceptance Guidelines for Approval

The following guidelines were developed by Zoe Diana Draelos, MD FAAD

National Rosacea Society
Seal of Acceptance
Guidelines for Approval

 

Products suitable for rosacea sufferers should fulfill the following basic requirements:

  • Skin care products for rosacea sufferers should not damage the skin barrier.
  • Skin care products for rosacea sufferers should not induce vasomotor instability, characterized by facial flushing and blushing.
  • Skin care products for rosacea sufferers should not contribute to heightened neurosensory awareness, characterized by stinging, itching, and burning.

Skin Barrier

The skin barrier is defective in patients with rosacea. This defective skin barrier is due to chronic inflammation. Skin care products for rosacea sufferers should ideally avoid all ingredients that produce irritant and allergic contact dermatitis. They should be hypoallergenic and non-acnegenic to ensure inflammatory papules and pustules do not worsen with use of the product. To demonstrate skin barrier suitability, all products that receive the NRS Seal of Acceptance should pass human repeat insult patch testing (HRIPT) with a panel of at least 30 persons. In addition, safety-in-use testing should be conducted on a panel of at least 30 persons with rosacea to demonstrated non-acnegenicity and lack of skin barrier damage. An ingredient review should be performed by an expert panel of three dermatologists, selected by the National Rosacea Society, to confirm the absence of irritant and allergenic substances in the formulation.

Vasomotor Instability

Rosacea is characterized by easily provoked flushing and blushing of the face. Any substance that provokes vasomotor effects should not be included in facial skin care formulations for rosacea sufferers. These substances are usually minor irritants. The HRIPT testing suggested for skin barrier assessment will also cover this testing need. The safety-in-use testing on rosacea subjects to assess the ability of the formulation to induce flushing and blushing can be concomitantly conducted with the acnegenicity testing on the same subjects.

Heightened Neurosensory Awareness

The skin of rosacea sufferers is easily irritated leading to the sensory perceptions of stinging, itching, and burning characterized by heightened neurosensory awareness. The substances that cause noxious sensory perceptions in rosacea sufferers are:

  1. Sensates
    Sensates are substances that cause a sensory perception when applied topically. These substances include menthol, peppermint, wintergreen, capsaicin, etc. They are designed to produce a sensation when applied to the skin; however, in rosacea sufferers they may produce flushing and blushing. Skin care products suitable for rosacea sufferers should not contain sensates.
  2. Volatiles
    Substances that evaporate quickly from the skin surface due to their high volatility should also be avoided in skin care for rosacea sufferers as they can provoke a cooling sensory response. These include ethanol, isopropyl alcohol, etc. Most volatiles are also solvents that can further damage the skin barrier.
  3. Penetration Enhancers
    Substances that induce penetration do so by damaging the skin barrier. This skin barrier damage can be perceived as stinging, itching, or burning by the rosacea sufferer. Propylene glycol and ethylene glycol are two common penetration enhancers that should be avoided.

The panel of three dermatologists will also be able to assess the presence of ingredients in skin care formulations that might induce heightened neurosensory awareness. The safety-in-use testing previously suggested on 30 subjects with rosacea should also evaluate the presence of sensory issues within a given formulation.

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