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Home » Directories » FDA Approved Drugs » Avita (tretinoin) Gel and Cream

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Avita (tretinoin) Gel and Cream

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Profile

Contact Information

Contact: Viatris
Website: https://www.viatris.com/en/search?q=avita

Currently Enrolling Trials

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    General Information

    Avita is a topical form tretinoin in a gel or cream formulation. Tretinoin is a retinoic acid. 

    Avita is specifically indicated for the treatment of acne vulgaris. 

    Avita is supplied as a cream or gel for topical administration. 

    Avita gel and cream should be applied once a day, in the evening, to the skin where acne lesions appear, using enough to cover the entire affected area lightly.

    During the early weeks of therapy, an apparent increase in number and exacerbation of inflammatory acne lesions may occur. This is due, in part, to the action of the medication on deep, previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after two to three weeks but more than six weeks of therapy may be required before definite beneficial effects are seen. 

    Mechanism of Action

    Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, Tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

    Side Effects

    Adverse effects associated with the use of Avita may include, but are not limited to, the following:

    skin reactions, including: excessive redness, edematous, blistered, or crusted

    Clinical Trial Results

    In two large vehicle-controlled clinical trials, Avita Gel 0.025%, applied once daily was more effective than vehicle in the treatment of facial acne vulgaris of mild to moderate severity. Percent reductions in total lesions at 12 weeks was -36 for gel and - 27% for placebo.

    In one vehicle-controlled clinical trial, Avita Cream 0.025%, applied once daily was more effective than vehicle in the treatment of facial acne vulgaris of mild to moderate severity: 46% versus 28% reductions in total lesions for cream versus placebo.

    Approval Date: 1997-01-01
    Company Name: Viatris
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