Evaluation of comedogenicity potential of the Demelan Face Wash by follicular biopsy test
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To determine the comedogenic potential of the Demelan Face Wash when applied topically under occlusive conditions on the skin of human subjects.
研究概览
简要总结
This study evaluates if Demelan Face Wash can clog pores (comedogenicity) by using a "follicular biopsy" test. This test involves applying the product on skin samples and examining their effects microscopically.
Study Details:
Objective: To assess whether Demelan Face Wash clogs pores when applied on human skin under specific conditions.
Design: The face wash and controls are applied on a patch three times weekly over four weeks. Each patch is kept on the skin for 48-72 hours.
Controls: The face wash is tested against isopropyl myristate (positive control) and saline (negative control), plus an untreated area.
Sample Application: 25 mg/cm² of each sample is applied to the skin on the back of the participants, covered with a pad and micropore tape.
Participants: 24 healthy adults will complete the study, with 3 additional for possible dropouts. The selected test area is between the shoulder blades and waist.
The study will help determine if the face wash is safe for acne-prone skin.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy male and female volunteers aged 18 to 65 with no active dermatological conditions
- •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
- •Subjects who have normal, dry, oily, combination (mixed) type of skin types.
- •Fitzpatrick photo type I to VI skin type.
- •Willingness to participate as evidenced by voluntary written informed consent.
排除标准
- •Subjects presenting and/or satisfying any of the following criteria will not be included in this study:
- •Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- •Women who are breast-feeding
- •Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction.
- •Presence of Acne, TLC more than 10 (Inflammatory & Non-Inflammatory).
- •Active dermatosis (local or disseminated) might interfere with the results of the study.
- •Considered immune compromised.
- •History of photosensitivity, & or diseases aggravated or triggered by ultraviolet radiation.
- •Participants with dermatographism.
- •Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk.
- •Use of the following topical or systemic medications: immunosuppressants, antihistamines, nonhormonal anti-inflammatory drugs, and corticosteroids up to 2 weeks before screening visit.
- •Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit
- •Intention of being vaccinated during the study period or vaccination within 3 weeks of the screening visit.
- •Currently receiving allergy injections, or due to receive an injection within 7 days prior to Visit1, or expects to begin injections during study participation
- •Previous history of atopic dermatitis, allergic reactions, irritation or intense discomfort feelings to topical use products, cosmetics, or medication
- •Known or suspected intolerance or hypersensitivity to any of the study materials (or closely related compounds) or any of their stated ingredients including any component of the study product.
- •History of sensitization in a previous study.
- •17 Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30days of the screening visit
- •Recent history (within the last years) of alcohol or other substance abuse.
结局指标
主要结局
To determine the comedogenic potential of the Demelan Face Wash when applied topically under occlusive conditions on the skin of human subjects.
时间窗: Study duration is 28 Days. Follow-up every 3rd day till the end of the study.
次要结局
- To determine the comedogenic potential of the Demelan Face Wash when applied topically under occlusive conditions on the skin of human subjects.(final outcome will measured at day 28.)
研究者
Sonal Shendkar
Skinovate Laser And cosmetic surgery center