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    Home > Biochemistry News > Biotechnology News > The FDA approves the first new mechanism therapy in 40 years for skin diseases that plague 85% of adolescents.

    The FDA approves the first new mechanism therapy in 40 years for skin diseases that plague 85% of adolescents.

    • Last Update: 2020-09-19
    • Source: Internet
    • Author: User
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    Acne is a skin disease caused by a variety of factors and is affected by four different pathways: excessive sebum, pore obstruction (excessive cornering), bacterial growth and inflammation.
    current treatments for acne include exosome retinoid, benzoyl peroxide and topical antibiotics.
    these treatments are effective in many patients, many patients still have skin symptoms that cannot be removed.
    , both vitamin A acid and benzoyl peroxide are irritating, which can make it difficult for some patients to use these therapies.
    play an important role in the pathological development of acne.
    androgens and other hormones that promote the secretion of fats, such as IGF-1, can lead to excessive sebum secretion, too much sebum will promote the growth of acne Bacillus acne, sebum changes will stimulate angiitis and inflammation.
    , however, it is surprising that no acne therapy has targeted this important signaling pathrapy that affects acne pathology over the past few decades.
    oral contraceptives and intransibodies can be effective in addressing the hormonal pathology of acne, they can lead to potentially adverse systemic reactions and cannot be used by men and pregnant acne sufferers.
    mechanism of effects of Clascoterone (Photo Source: Resources) Clascoterone (1% emulsion) is a "first-in-class" exo-androgen-inhibitor inhibitor.
    It is able to compete with androgens, especially testosterone (DHT), in combination with androgen receptors in the sebum glands and hair follicles, blocking downstream signaling paths of androgen receptors and preventing excessive sebum secretion and inflammation.
    In two key Phase 3 clinical studies with a total of 1,440 patients, 18.4% and 20.3% of patients reached the clinical end of successful treatment at the end of the 12-week course, while the placebo group reached 9.0% and 6.5%, respectively.
    the results of both trials have been published on JAMA Dermatology.
    in a commentary published at the same time, the innovative treatment could lead to new weapons for treating acne, noting that it may reduce the dependence of some patients on oral antibiotics.
    oral antibiotics are the most common oral treatment for acne, but many patients take them for longer than the guidelines and are potentially at risk.
    addition to treating acne, Cassiopea is developing clascoterone as a treatment for androgen hair loss.
    androgens account for more than 80% of people with hair loss.
    The root cause is that due to high levels of male hormones in the body, the dehydrotestosterone converted into skin tissue binds to the androgens in the hair follicles, causing the hair follicles to shrink and eventually fail to regenerate.
    this leads to typical early baldness symptoms in patients with androgenic hair loss.
    androgen hair loss, which is more common in men, can also affect women.
    's research and development program and progress (Photo: Cassiopea's official website) Clascoterone has the potential to reverse hair follicle atrophy and promote hair growth by blocking the effects of testosterone.
    , the company announced the results of its aggressive Phase 2 clinical trial for patients with androgen hair loss.
    phase 3 clinical trial to treat male androgen hair loss patients will begin this year.
    : sACOPEA RECEIVES FDA APPROVAL FOR WINLEVI ® (CLASCOTER CREAMONE 1%), FIRST-IN-CLASS TOPICAL ACNE TARGETING THE ANDROGEN RECEPTOR. Retrieved August 27, 2020, from .2, CASSIOPEA ANNOUNCES VERY POSITIVE PHASE II TWELVES MONTHS RESULTS FOR BREEZULA ® (CLASCOTERONE) IN TREATING ANDROGENETIC ALOPECIA. Retrieved August 27, 2020, from .3. Eichenfield et al, (2020). Open-label, long-term extension study to evaluate the safety of clascoterone (CB-03-01) cream, 1% twice daily, in patients with acne vulgaris. JAAD, (4) Herbert et al, (2020). Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne Two Phase 3 Randomized Clinical Trials. JAMA Dermatology, doi: 10.1001/jamadermatol.2020.0465. Barbieri et al, (2020). A New Class of Topical Acne Treatment Addressing the Hormonal Pathogenesis of Acne. JAMA Dermatology, doi: 10.1001/jamadermatol.2020.0464.
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