An Investigator initiated, open-label, Single arm, non-randomized clinical study to evaluate the effectiveness, tolerability and safety of Besifloxacin hydrochloride in the treatment of subjects suffering from Gram-negative facial folliculitis. - Gram Negative Folliculitis (GNF)

Dr Rohit Batra0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1.Subject is willing and able to give written informed consent.
•2.Healthy male or non-pregnant female aged Ã¢â?°Â¥ 18 and Ã¢â?°Â¤ 80 years.
•3.Clinical diagnosis of suspected Acute GNF with papules, pustules and peri nasal and/or peri oral involvement.
•4.Microbiological analysis confirming presence of gram-negative bacteria (Microbiology analysis report will be available approximately 72 hours from sample collection. Report is not required for screening or starting treatment.)
•5. Actively cooperating to participate in the trial, to follow the instructions of the Investigator and to attend the agreed visits.

•1.Presence of skin lesions, e.g. open wounds or ulcers in the respective skin areas.
•2.Presence of skin diseases other than acute folliculitis and acne interfering with study treatment.
•3.Treatment with epidermal growth factor receptor (EGFR) inhibitors.
•4.Topical or systemic use of any dermatological product (e.g. medications, medicinal products, cosmetic products) on the trial areas during the trial.
•5.Any systemic or topical immunosuppressive therapy (e.g. corticosteroids) within 3 weeks prior to randomization.
•6.Congenital or acquired immunodeficiency.
•7.Participation in any other trial within 30 days prior to randomization or during the trial.
•8.Contraindications to any component of the study medication.
•9.History of drug, alcohol, or chemical abuse.
•10.Females of childbearing potential may not be recruited if they are not willing to use of effective method for contraception throughout the study period.

发起方

Dr Rohit Batra