BIAFINE Emulsion for cutaneous application Ref.[51155] Active ingredients: Trolamine

Source: Medicines Authority (MT)  Revision Year: 2023  Publisher: JOHNSON & JOHNSON Santรฉ Beautรฉ France, 1, RUE CAMILLE DESMOULINS, 92130 ISSY-LES-MOULINEAUX, FRANCE

5.1. Pharmacodynamic properties

Pharmacotheraputic Group: SKIN PROTECTIVE (D: Dermatology)

Trolamine, when used with fatty acids such as stearic acid, acts as an emulsifying agent.

Following cutaneous application, it provides both occlusive and hydrating properties and increases the recruitment of macrophages to the wound site, enhancing healing at the dermal level and stimulating the formation of granulation tissue.

5.2. Pharmacokinetic properties

The formulation promotes hydration and its effects are localised to the superficial layers of the skin. Systemic effects are not anticipated.

5.3. Preclinical safety data

Trolamine has been negative in in vitro tests for mutagenicity and chromosomal aberrations.

The results of carcinogenicity studies done in rodents have been equivocal. No studies were found on the carcinogenic potential of trolamine in humans.

A reproductive study found for trolamine concluded that it was embryotoxic in chickens. No reproductive data has been found on the effects of trolamine in humans.

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