A Single Centre, Open Label, Single Arm Pilot Study to Investigate on Safety and Efficacy of the Acne buster Lotion on Subjects with Mild to Moderate Acne Vulgaris on Face

ICHIMARU PHARCOS CO Ltd0 个研究点目标入组 24 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Male and female subjects between 18 to 40 years
•Subjects willing to give the voluntary written informed consent.
•Subjects having acne vulgaris on face with mild to moderate severity on GAG score
•Subjects willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
•Subjects willing to abstain from using any other treatments for acne vulgaris.
•Subjects not having other skin diseases on facial skin such as allergic contact dermatitis, atopic dermatitis, tinea faciei, tinea barbae, nodulocystic acne, acne conglobata, rosacea and DLE/SLE
•Few lesions of asymptomatic pityriasis alba is acceptable.
•Subjects who uses make ups should be willing to continue the same brands of make-ups and should agree not to change make â?? up brands throughout the stud period.
•Safe contraception

•Subjects not willing to give voluntary informed consent and Subjects not able to come for the timely follow up
•Usage of any other medicinal products which can affect the course of the disease or the therapy
•Subjects with very severe acne on GAG score
•Secondary acne such as drug induced acne, chloracne, acneiform eruptions (dermatitis), steroid induced acne and very severe acne such as nodulocystic acne or acne conglobata, acne fulminans
•Subjects on other modalities of treatment for the acne (topical treatment <2 weeks, systemic treatment < 4 weeks)
•Systemic pre-treatment with isotretinoin within 3 months prior to enrolment
•Existence of a disease that demands systemic and/or topical â?? or steroid-administration
•Other associated uncontrolled systemic diseases such as diabetes mellitus, hypertension and other systemic diseases like renal functional abnormalities, liver abnormalities, tumors.
•Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
•Subjects who have undergone other dermatological procedures such as chemical peels, microdermabrasion, intralesional steroid injections, laser treatment 30 days prior to baseline.
•Alcohol or drug or medication abuse

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