To evaluate the efficacy of cosmetic products in skin lightening of healthy human volunteers.

Phase 2

Completed

• Conditions: Female subjects at least 45 subjects in the age group of 40-48 yrs, 30 subjects in the age group of 49-60 yrs, at least 30 women with post inflammatory hyperpigmentation marks on face.

• Registration Number: CTRI/2018/11/016259
• Lead Sponsor: ITC Life Sciences Technology Centre

Brief Summary

**Subject Population** Hundred and Five (105) Indian healthy human adult female subjects will participate in the study:· At least 30 subjects in the age group of 49-60 yrs (Menopausal phase) ·At least 45 subjects in the age group of 40-48 yrs (Perimenopausal phase)·At least 30 women (mothers of 2-8yr old children) with post inflammatory hyperpigmentation marks on face, representing varied skin types – oily, normal, dry, combination and sensitive skin. Each product would be received by at least 35 subjects of which at least 15 women will be from the Pre-Menopausal age group, 10 subjects from the Menopausal group and 10 women with post inflammatory hyperpigmentation marks. Determination of sensitivity will be done on the basis of self declaration with information on the stimuli, manifestation and symptoms.In case of not being able to meet the ideal criteria, a variation of ± 2 subjects per skin condition per treatment group is permissible. ***Briefing and Procurement of Informed Consent Form*** Study procedure, restrictions and requirements will be explained in detail to the volunteers in the language they understand. All queries from the subjects pertaining to the study will be answered to their satisfaction. Subjects willing to participate in the study will be asked to give their consent by signing the Informed consent form, the contents of which will also be explained to them in detail, in the language they understand. **Screening** Subjects providing signature in informed consent form will be screened by the investigator as per the inclusion exclusion criteria, medical history and skin sensitivity test. Only subjects who meet the requirements of this section, will be enrolled in the study. ***Skin sensitivity test:*** About0.01g of investigational products will be applied at the back of subject’s earlobes as per randomization on the right and left ears. The product needs to be retained on ear lobes for 24 hours and checked by Dermatologist for symptoms of sensitivity. Only those subjects who show no allergic / irritation symptoms will be enrolled in the study. **Study restrictions:** Subjects are required to abstain from using any product (Therapeutic/ Natural/ Synthetic/Cosmetic) other than the provided cleansing solution and investigational products on face and also from undergoing any cosmetic treatments such as facial masks, packs, bleaching, etc. either at home or at parlour during the entire study duration. Subjects are required to visit the evaluation site without any makeup including those for eyes and lips during all evaluation visits. **Study phase*****Pre-conditioning*** Subjects will be provided with a mild cleansing solution to use for all cleansing purposes during the study period. Subjects will be asked to wash their face with the provided cleansing solution and rinse completely with water. Face needs to be dried by gentle dabbing of tissue paper. ***Acclimatization*** Subjects will need to get acclimated under controlled temperature and humidity (22oC±5oC and 50%± 30% Relative Humidity) for 15- 30 minutes prior to measurements. ***Baseline evaluations*** Evaluation sites·Forehead, Right and Left crow’s feet area for wrinkles/ fine lines ·Right and Left cheeks for skin moisturization and Pores ·Forehead, Right and Left cheeks for skin Color, skin tone and dark spots  Subjects will be evaluated instrumentally and visually for change in skin conditions from baseline. ***Product application*** About 4-5 drops to be dispensed using the dropper onto the palms and spread over the entire face after having washed face with the provided cleanser for the entire study course.Subjects will be requested to maintain a diary to record daily product usage. ***Post treatment assessment*** Subjects will be evaluated instrumentally and visually for change in skin conditions from baseline immediately post first application, and at weeks 2, 4, 6 and 8.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-11
• Study Completion: 2019-04-02
• Last Update Posted: 2022-07-01

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 105

Inclusion Criteria

• 1.Subject is willing to give a written informed consent 2.Subject is a healthy adult female in the age range of 25.
• 60 years 3.At least 45 subjects in the age group of 40-48 yrs. (Perimenopausal phase) , 30 subjects in the age group of 49-60 yrs. (Menopausal phase). 4.At least 30 subjects having a wrinkle score between 2 and 4 (moderate/ medium wrinkles) as per the photonumeric scale 5.At least 30 women (mothers of 2-8yr old children) with post inflammatory hyperpigmentation marks on face (post acne / estrogen imbalance related marks). Subjects with mild melasma can be taken in the study. 6.Subject who is willing to comply with the study protocol and abide by the study restrictions such as refraining from using cosmetic/ medicinal/ ayurvedic/ natural products on face and also willing to abstain from undergoing any facial treatments such as facial masks, packs, waxing, threading etc. either at home or at parlour other than the provided product during the entire study course. 7.Subjects willing to visit the centre as per the specified schedule for regular follow up visits. 8.Subjects willing to undergo UPT at the time of screening visit.

Exclusion Criteria

• 1.Subject who is currently pregnant (as confirmed by the urine pregnancy test) or nursing or contemplating pregnancy (as disclosed voluntarily) during the study course.
• 2.Subject with a known history or present condition of allergic response to any cosmetic products, toiletries or their ingredients including fragrance.
• 3.Subject with a medical history of disease or condition or a concurrent illness or pre-existing or dormant dermatologic condition (psoriasis, rosacea, rashes, eczema etc.) that could interfere with the study results.
• 4.Subject who has used any systemic medication (antibiotics, oral contraceptive pills, retinoids, steroids, spironolactone or any anti-acne medication) within past 4 weeks or any topical facial medication within 2 weeks before the start of the study, which could compromise the study.
• 6.Subject with excessive facial hair or scars, which could interfere with evaluation.
• 7.Subject who shows no skin sensitivity symptoms to the investigational products during the skin sensitivity test.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dermatological safety, skin lightening and anti- aging efficacy of the investigational products (IP) over baseline and the reference products.	Approximately 8 weeks

Secondary Outcome Measures

Name	Time	Method
Overall changes in skin conditions on usage of the IP in comparison to baseline and the reference product	Approximately 8 weeks

Trial Locations

Locations (1)

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

MS Clinical Research Pvt. Ltd.

🇮🇳Bangalore, KARNATAKA, India

Dr Sapna R

Principal investigator

08041125934

sapna.r@mscr.in