CTRI/2026/01/101667招募中不适用
A clinical study to evaluate efficacy of the two study products for improvement in skin appearance in an 8-week full-face application design with male participants.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
In this study the skin colour (on forehead) & spots colour (on face), glow/radiance, hydration and barrier
properties will be assessed visually & instrumentally at baseline and at various time points post
treatment. These visual scores &/or instrumental measurements will be used to evaluate the efficacy of
test products on skin and spot color as well as other attributes like even tone, hydration, glow at various
timepoints as specified in this full-face product application study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male participants between 18 to 55 years (both inclusive) of age.
- •Participants are in good health condition as per the health history questionnaire with no disease state or physical condition that the Investigator believes could interfere with the interpretation of the data.
- •Participant able to read, understand and sign an appropriate informed consent form indicating her willingness to participate.
- •Participants having skin forehead color in the range of 4 to 7.25 (as per Unilever India Clinical Skin Colour Shade Card).
- •2 to 3 participants will be selected having forehead skin color of 4 as well as 7.
- •The participants to be enrolled across the entire colour range (i.e. not skewed towards a few shades)
- •Having 3 spots of 3 mm diameter.
- •Spot Type, Size, No. of spots- Participant having about 3 spots (freckles or solar Lentigines or senile lentigines or PIH post acne) on full face, with at least one spot of 3 mm and the other two spots of greater than or equal to 2 mm.
- •Note: Recruitment to be done basis existing CRO database or as during screening with documented evidence of 3 years of sunspots history for the same spot selected in this study (type of evidence used needs to be documented in EDC against each sunspot).
- •Declaration from dermat to also be provided along with study completion report.
- •Participants will be selected to have a range of forehead skin brightness (L) as follows: • 50–55 = 50 percent of participants • 46–49 = 25 percent of participants • 40–45 and 56–60 or 65 = remaining 25 percent
- •Participants having uneven pigmentation (mild to moderate) on face e.g., pigmentary uneven skin tone patches, spots/hyperpigmentation.
- •Very large patches on face to be avoided.
- •Having moderate facial skin dryness (Score 2.0 on UL dryness scale: Generalized slight powderiness.
- •Early cracking or occasional small lifting scales may be present).
- •Note: Based on the weather conditions at the time of screening, in case of difficulty in perceiving facial visual dryness, skin hydration readings as measured by Corneometer to be less than or equal to 30 units may be considered Not having outdoor job that requires lots of sun exposure.
- •Note- Self perceived skin type will be recorded at the time of recruitment.
- •10.Not having outdoor job that requires lots of sun exposure.
- •Participants are willing to participate in the study (Time of their stay at clinical site (9 to 10 hrs.) on the study visit days including screening visit).
排除标准
- •Participants who are employees of Unilever or CRO.
- •Participants who participated in a study involving the treatment site within 2 months of the start of this study or is currently participating in such a study.
- •Participants with dry or scaly facial skin.
- •Participants with any other signs of significant local irritation, erythema, or skin disease on the face and as well as on the visible parts of the skin site.
- •Participants with self-perceived pimple prone and, or sensitive skin.
- •Those with a history of current skin diseases such as psoriasis, eczema, and atopic dermatitis.
- •Participants taking medication continuously or regularly every day such as corticosteroids or non- steroidal anti-inflammatories, topically for four weeks or orally for eight weeks prior to the study.
- •Participants with excessive hair, tattoos, scars, or wounds on the lateral forearm
- •Participants having chronic illness or had major surgery in the last year.
- •Participants undergo any treatment either cosmetic treatment or medical treatment of any skin condition on face or body.
- •Participants taking any oral antibiotic medication currently or within the last 8 weeks.
- •Participants are allergic or sensitive to bar cleansing products, creams or lotions, artificial jewellery, or anything else.
- •Participants taking medication for any condition which the Investigator believes may influence the interpretation of the data.
- •Participants have hair styles which cover half or part of the forehead.
研究者
Dr Rajeshree Mayekar
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.
研究点 (1)
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