GLYCEROL/VASELINE/PARAFFINE CRISTERS 15 %/8 %/2 % Cr T/250g

1 g of GLYCEROL/VASELINE/PARAFFIN CRISTERS contains 0,15 g of glycerol, 0,08 g of petrolatum and 0,02 g of liquid paraffin.

Excipient with known effect: propyl parahydroxybenzoate (E216).

Adjunctive treatment of dry skin states associated with certain dermatoses such as atopic dermatitis, ichthyosis-like states, psoriasis.

Adjunctive treatment of superficial burns of small extent.

Dosage

For adults and children, including infants, apply the cream in a thin layer to the areas to be treated once or twice a day, or more if necessary.

Method of administration

Cutaneous use.

Hypersensitivity to the active substances or to any of the excipients listed in section Composition.

Do not swallow.

It is recommended not to apply to an infected lesion or under an occlusive dressing.

This medicine contains propyl parahydroxybenzoate and may cause allergic reactions (possibly delayed).

No interaction studies have been performed.

Pregnancy

No effect is expected on pregnancy because systemic exposure to glycerol, petrolatum and paraffin is negligible. GLYCEROL/VASELINE/PARAFFIN CRISTERS can be used during pregnancy.

Breast-feeding

Given the nature of the active ingredients, no risk is expected. It is only recommended not to apply GLYCEROL/VASELINE/PARAFFIN CRISTERS to the breast during breastfeeding.

Fertility

No effect on fertility is expected because systemic exposure to glycerol, vaseline and paraffin is negligible.

GLYCEROL/VASELINE/PARAFFIN CRISTERS has no or negligible effect on the ability to drive vehicles and use machines.

The following undesirable effects have been reported during clinical studies and since the marketing of this medicinal product:

Very common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥1/1 000 to <1/100)

Rare (≥1/10 000 to <1/1000)

Very rare (<1/10 000)

Frequency not determinable (cannot be estimated from the available data).

* irritation, redness, pain or itching at the application site

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

No cases of overdose have been reported.

Pharmacotherapeutic class: EMOLLIENT and SKIN PROTECTANT, ATC code: D02AC

Emollient and moisturising cream.

The mechanisms of action of this medicine are as follows:

• Decrease in insensible water loss: petrolatum and paraffin form a lipid layer limiting the water loss from the stratum corneum and allowing the retention within it of water-soluble and hygroscopic substances.

• Increase in hydration of the superficial layers of the skin due to the hygroscopic power of glycerol and its penetration into the epidermis.

The skin protective effect has also been demonstrated by tests ex vivo performed on delipidated tissue implants. These tests showed rapid restructuring of the lipid barrier with demonstration of the emollient activity of the glycerol/petrolatum/paraffin combination, involving restoration of the homeostasis of corneodesmosomal junctions.

These properties, demonstrated in pharmaco-clinical studies on validated models, promote restoration of the hydration state and barrier function of the skin, which is likely to reduce phenomena of irritation, pruritus and scratching.

All of these properties were objectified in clinical studies representative of a state of cutaneous dryness in children:

• Ichthyosis: double-blind study versus placebo for 28 days followed by an open-label period of 2 months.

The glycerol/petrolatum/paraffin combination significantly improves symptomatology as assessed by the SRRC score (Scaling, Roughness, Redness, Cracks fissures): 65% of responders with this medicinal product, versus 50% with excipient, the response being defined by a decrease in the SRRC score of at least 50%.

The decrease in the SRRC score was significantly greater (p< 0,05) on days 14 and 28 in patients treated with the glycerol/petrolatum/paraffin combination compared with the placebo group (double-blind period). During the open-label period, a significant decrease (p<0,01) in the SRRC score as well as in pruritus was observed up to day 84 in patients treated with the glycerol/petrolatum/paraffin combination.

• Atopic dermatitis in children: double-blind study versus placebo for 28 days followed by an open-label period for 2 months with re-introduction of the glycerol/petrolatum/paraffin combination in patients who relapse on day 56.

The glycerol/petrolatum/paraffin combination significantly improves the dryness of the skin in patients presenting with moderate to severe xerosis (glycerol/petrolatum/paraffin combination 43% versus placebo 29%, p< 0,001) during the double-blind period (D1 to D28). The significant improvement in atopic dermatitis in patients presenting with moderate to severe xerosis is observed from day 7. The difference observed in xerosis increases over time from day 7 to day 28.

When the glycerol/petrolatum/paraffin combination is applied to xerotic skin, the hydration index measured with the corneometer reaches normal hydration values on day 28 (>40 corneometer units).

The results observed during the open-label period (D29 to D84) show that in responder patients, stopping the emollient leads to a relapse of xerosis, and in non-responder patients, introducing or continuing the emollient treatment after day 28 leads to an improvement of xerosis.

The results of these clinical studies highlight the benefit of long-term treatment with the glycerol/petrolatum/paraffin combination:

• in responding patients, discontinuation of treatment leads to a worsening of the xerosis and of the dermatosis,

• resuming treatment leads to an improvement of xerosis and dermatosis.

Preclinical data show good skin tolerance of this medicinal product, also confirmed in humans. The cream is shown to be non-irritating to the eyes. Devoid of phototoxic potential, it presents, in animals, a low sensitising and photosensitising potential, but the risk is considered negligible in humans due to the absence of absorption beyond 290 nm.

21 months.

After first opening of the tube: 6 months.

For storage conditions of the medicine after first opening, see section Shelf life.

No special requirements.