CTRI/2024/05/067758尚未招募Unknown
An open label study to evaluate the Anti-Acne potential of the Kogigold cream in reduction of inflammatory and non-inflammatory acne lesion on oily & or mixed skin types of volunteers. ?. - NI
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1.Male and female subjects aged 18 to 45 with mild to moderate Acne Vulgaris. Acne on the face, either non-inflammatory lesions (i.e., open and closed comedones) AND inflammatory lesions (i.e., papules and pustules).
- •2.Subjects with facial acne having IGA grade 1 and 2
- •3.Subjects with Oily & or Mixed type of facial skin.
- •4.Good general and mental health with, in the opinion of the investigator or medically qualified designee with no clinically significant and relevant abnormalities in medical history or upon physical examination
- •5.Willingness to participate as evidenced by voluntary written informed consent
- •6.Subject are willing to comply with study instructions and return to the clinic for required visits.
排除标准
- •1.Subject is pregnant, lactating, or is planning to become pregnant during the study.
- •2.Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy
- •3.Subject has greater than two (2) facial nodules.
- •4.Subject has nodulocystic acne
- •5.Subject is currently enrolled in an investigational drug or device study OR has been treated with an investigational product or device within 30 days prior to the initiation of treatment (Baseline)
- •6.Subject has facial hair especially full-grown beard that could interfere with the study assessments in the opinion of the investigator.
- •7.Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
- •8.Subject has used any of the prohibited topical anti-acne treatments or procedures prior to the study unless appropriate washout period is documented.
- •9.Patients exhibiting acute or chronic dermatological, medical, and/or physical conditions which would preclude application of the test materials and/or influence the outcome of the study.
- •10.Patients who must use oral corticosteroids and/or oral immunosuppressive drugs (steroid inhalers or decongestant nose drops and/or eye drops are permitted).
- •11.Active dermatosis (local or disseminated) that might interfere with the results of the study.
- •12.History of diseases aggravated or triggered by ultraviolet radiation.
- •13.Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30days of the screening visit.
研究者
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