CTRI/2023/04/051261尚未招募Unknown
Efficacy Evaluation of Cosmetic Formulation in Conferring Skin Tan Lightening Benefits in Healthy Human Participants.
ITC Life Sciences Technology Centre0 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
- Unknown
- 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. Volunteer in the age group of 19 to 50 years
- •2· Volunteers with visible skin Tan on face, at least 2 shade darker than a Sun protected upper volar arm
- •3· Volunteers with a L value in the range of 40 to 60 on cheeks, and L value at least 3 units higher than cheeks on volar upper arm/ bicep area (C1).
- •4· Participants with varied skin type i.e. normal, dry, oily, combination and sensitive skin in nearly equal ratio
- •5· At least 15 volunteers with few solar lentigines on face
- •6· At least 35 volunteers with Persistent Tan (atleast 4weeks old)
- •7· At least 35 volunteers with a recent tan (Developed on the day of baseline visit)
- •8· Persistent Tan since (at least 4weeks) and recent tan (Developed on the day of baseline visit) in each case
- •9· Volunteers willing to abide by the study protocol and refrain from using any product other than the provided Investigational product during the study course.
- •10· Volunteers willing to visit the site for periodic assessments on the scheduled dates.
- •11· Volunteer who exhibits good tolerance to the investigational product with no signs of sensitivity in the acute irritation test
排除标准
- •1. Pregnant or lactating women
- •2· Participants undergoing treatment for Seborrhoea, Acne, Dermatitis, skin lightening/ any other cosmetic/ dermatologic skin condition on face
- •3· Participants with pre-existing systemic disease requiring long-term medication (self-declaration)
- •4· Participants with genetic and endocrinal disorders [ self-disclosure]
- •5· Participants with drug induced acne [ self-disclosure]
- •6· Participants with any other signs of significant local irritation or skin disease.
- •7· Participants on oral hormonal treatment or oral medications (e.g., steroids, anti-oxidant) for eight weeks prior to the study which will compromise the study.
- •8· Participants who may change personal nutrition habits and other habits as per investigatorâ??s discretion.
- •9· Participants who have participated in a similar investigation or any other clinical product evaluation test in the past four weeks
- •10· Participants under the influence of alcohol and/or drugs as well as addiction.
- •11· Participants with severe psychological illness or intellectual inability to understand the study.
- •12· Participants who have wounds, sunburn, scars, tattoos or piercings at the skin test sites.
- •13· Participants with uncontrolled disease (severe heart/circulatory, liver, kidney or lung disease, severe diabetes mellitus) or chronic infections (hepatitis, HIV)
- •14· Participants who have proven allergies against cosmetic ingredients or prior intolerance responses after applying cosmetic products. [self-disclosure]
- •15· Participants who are taking antihistamines and/or medication to suppress the immune system (e.g., corticoids, cytostatics) and/or retinoids
- •16· Participants who might participate in any other clinical study during participation in the current study
- •17· Participants currently taking any medication, which the investigator believes may influence the interpretation of the data.
- •18· Participants having chronic or acute skin disease at the skin test sites within the last 14 days prior to the beginning of the study and/or during the study or had major surgery in the last year.
- •19· Participants undergoing any treatment of any active skin condition
- •20· Participants allergic or sensitive to bar cleansing products, creams/lotions, artificial jewellery or anything else.
- •21· Participants who are pregnant or nursing.
研究者
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