To evaluate the anti-aging efficacy of the products in healthy human volunteers

Phase 2

Completed

• Conditions: Forty Indian healthy human adult male and female subjects (35-60 Years) in the ratio of 1:3 will participate in the study.

• Registration Number: CTRI/2018/12/016533
• Lead Sponsor: ITC Life Sciences Technology Centre

Brief Summary

**Study population**

Forty(40) Indian healthy human adult male and female subjects in the ratio of 1:3will participate in the study.

**Briefingand Informed Consent Form Procedure**

Study procedure,restrictions and requirements will be explained in detail to the volunteers inthe language they understand. All queries from the subjects pertaining to thestudy will be answered to their satisfaction. Subjects willing to participatein the study will be asked to give their consent by signing the Informedconsent form, the contents of which will also be explained to them in detail,in the language they understand.

**Screening**

Subjects providingsignature in informed consent form will be screened by the investigator as perthe inclusion exclusion criteria, medical history and skin sensitivity test.Only subjects who meet the requirements of this section, will be enrolled inthe study.

In case of subjectshaving used a fairness product in the recent past, a pre-conditioning phase of1 week is mandatory wherein they need to abstain from using any product otherthan the provided mild cleanser on face.

**Skinsensitivity test:** About0.01gof investigational product will be applied at the back of subject’s earlobeon the right or left ear. The product needs to be retained on ear lobe for 24hours and checked by Dermatologist for symptoms of sensitivity. Only thosesubjects who show no allergic / irritation symptoms will be enrolled in thestudy.

**Pre-conditioning**

Subjects will beprovided with a mild cleansing solution to use for all cleansing purposesduring the study period. Subjects will be asked to wash their face with theprovided cleansing solution and rinse completely with water. Face needs to bedried by gentle dabbing of tissue paper.

**Acclimatization**

Subjects will needto get acclimated under controlled temperature and humidity (22oC±5oCand 50%± 30% Relative Humidity) for 15- 30 minutes prior to measurements.

**Baselineevaluations**

Subjectswill be evaluated instrumentally and visually for change in skin conditionsfrom baseline.

**Productapplication**

The IP will beapplied on the face, after having washed face with the provided cleanser forthe entire study course.

One pump of theprovided investigational product to be applied on face, twice daily (postmorning bath and 2 hours prior to bed time after having washed face with theprovided cleanser) for the entire study course.

Subjects will be requested to maintain adiary to record daily product usage.

**Posttreatment assessment**

Subjects will be evaluated instrumentally and visually for change inskin conditions from baseline immediately post first application, at weeks 2,4, 6 and 8.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-17
• Study Completion: 2019-02-21
• Last Update Posted: 2022-07-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1.Subject is willing to give a written informed consent 2.Subject is a healthy adult male and female in the age range of 35-60 years 3.Subjects with mild to moderate wrinkle crow’s feet on scale 3 and above, referring to the Modified Anti-Ageing Atlas- 6 point scale.
• 4.Subject has at least 2 dark spots on face that are age spots/lentigines-marks other than melasma/chloasma.
• 5.In case of having used fairness products/skin anti-aging products in the near past subject willing to undergo a wash out period of 1 week, wherein they would abstain from applying any product other than the provided cleanser on face.
• 6.Subjects willing to abstain from using any cosmetic/ medicinal/ ayurvedic/ natural products other than the one provided for testing on face during the study course.
• 7.Female subjects of reproductive age group willing to undergo UPT at time of screening visit.
• 8.Subject who shows good tolerance (no sensitivity symptoms) to the investigational products during the skin sensitivity test.

Exclusion Criteria

1.Subjects who are pregnant or lactating or contemplating pregnancy during the study course 2.Subjects with a known history or present condition of allergic response/ sensitivity to sun, sunscreens/ cosmetics/ fragrances 3.Subject having skin condition like psoriasis, atopic dermatitis or other cutaneous manifestations which would interfere with the test readings 4.Subjects on medications like retinoid, steroids, antihistamines, oral contraceptives, or those for hormonal balance which could compromise the study results 5.Subjects with tattoos, dense hair, moles, warts on face at the site of evaluation 6.Subjects having participated in a similar investigation in the past 2 month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The dermatological safety and anti- aging efficacy of the investigational product (IP) over baseline	Approximately 8 weeks

Secondary Outcome Measures

Name	Time	Method
The safety of the investigational product (IP).	Approximately 8 weeks

Trial Locations

Locations (1)

MS Clinical Research Pvt. Ltd.; 🇮🇳 Bangalore, KARNATAKA, India

MS Clinical Research Pvt. Ltd.

🇮🇳Bangalore, KARNATAKA, India

Dr Mukesh Ramnane

Principal investigator

08041125934

mukesh.ramnane@mscr.in