CTRI/2019/10/021562尚未招募未知
An open-label,randomized, monocentric study to evaluate the anti-acne efficacy and safety of LactoSporin® 2% in male and female subjects.
Sami Labs Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1 Male and female adult subjects (preferably in the ratio of 1:1) in general good health as determined from a recent medical history general physical examination, dermatological assessment.
- •2 Subjects with in the age of 18 to 35 years (both ages inclusive).
- •3 Subjects with normal to oily skin type (preferably in the ratio of 1:3).
- •4 Female subjects of child bearing potential with negative pregnancy test during screening and willing to follow an approved method of contraception during the study.
- •5 Subject with Fitzpatrick skin types III to V.
- •6 Subjects with mild to moderate acne on overall face.
- •7 Subjects not having hair style which covers almost the entire forehead.
- •8 Subject who agrees not to use any other product/treatment/home remedy/soap bar on their face during the study period other than the test product.
- •9 Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period.
- •10 Subjects who agree not to expose to excessive sun light. (Sun exposure not more than half an hour daily and during that time use of umbrella to cover face).
- •11 Subjects who agree to remove all jewellery on/around face (e.g., necklace, earrings, if possible, nose ring), during imaging.
- •12 Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
- •13 Subjects willing to abide by and comply with the study protocol.
- •14 Subjects who have not participated in a similar investigation in past four weeks.
- •15 Subjects who are willing to abstain from participation in any other clinical study during course of the current study.
排除标准
- •1 Subjects who have undergone a facial procedure (e.g., laser peel, microderm abrasion or blue light treatment, etc) within the past 4 weeks or if it is planned to be performed during the conduct of the study.
- •2 Subjects unwilling or unable to comply with the study procedures.
- •3 Subjects involved in tasks with long exposure to sunlight or use of any known photosensitizing agents like tanning booths, sun lamps, etc during the study period.
- •4 Subjects with, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face that could interfere with the assessment as determined by the investigator.
- •5 Subjects who are using any of the systemic medications likely to cause or abate acne e.g., oral phenytoin or any other antiâ??epileptic medication, finasteride, spironolactone, flutamide, testosterone, dietary bodyâ??building protein preparations, mega-doses of vitamin D (more than 2000IU per day), vitamin A (more than 5000IU per day) or vitamin B-12 (more than 1mg/day, haloperidol, halogens (e.g.,iodide, bromide),lithium or Phenobarbital. However, subjects who are using or plan to use multivitamins,iron supplements or folate are acceptable.
- •6 Skin condition (i.e., atopic dermatitis, seborrheic dermatitis, skin cancer, actinic keratosis or psoriasis) which in the opinion of the investigator may affect the action nor evaluation of the study medication or place the subject at undue risk.
- •7 Use of topical corticosteroids or hormonal preparations or antibiotics or retinoids within the past 2 weeks on the face or systemic corticosteroids or antibiotics within the past 4 weeks or during the study period. However, use of inhaled, intraarticular or intra â??lesional steroids other than for facial acne is acceptable.
- •8 Use of facial preparations like abradants, peels, masks, washes, soaps or moisturizers containing glycolic acid, salicylic acid, Alpha â?? or beta- hydroxyl acids or other acids, benzoyl peroxide (BPO) or sulfacetamide sodium within the past 2 weeks or during the study period.
- •9 Subjects must be willing to abstain from alcohol, caffeine, and nicotine throughout the study duration/patient is willing to limit alcohol, caffeine, and nicotine consumption while in the study.
- •10 Subjects with the habit of consumption of excessive oily & spicy food.
- •11 Subjects with a clinically significant disease(s) or disorder(s) other than facial acne vulgaris that in the opinion of the Investigator may (i) put the subject at risk because of participation in the study (ii) interfere with the study evaluations or (iii) cause concern regarding subjectâ??s ability to participate in the study.
- •12 Subjects having any noduloâ??cystic acne lesions.
- •13 Subject with any other signs of significant local irritation or skin disease.
- •14 Subject currently taking any medication including food supplements,which the investigator believes may influence the interpretation of the data.
- •15 Subject having chronic illness or had major surgery in the last year.
- •16 Subjects undergoing any treatment of any skin condition on their face.
- •17 Subjects not willing to discontinue other topical facial products.
- •18 Subject allergic or sensitive to bar cleansing products, creams/lotions, artificial jewellery or anything else.
- •19 Patients who have conditions that may interfere with the evaluation of acne vulgaris. Such conditions includ
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