Safety & efficacy assessment of products on skin.

Not yet recruiting

Conditions: having dry skin on inner forearms with corneometer reading of 30

Registration Number: CTRI/2022/05/042725

Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief Summary: The objective of this study is to evaluate themoisturization effect of two skincare formulations â€“ Cebhydra Cream (WWY0018)& Cebhydra Lotion (WWY0030) on healthy human female subjects.

Theevaluation is performed using:

n  **SubjectSelf Evaluation (SSE) Questionnaire** **(MoisturizationEffect & Safety)**

n  **SubjectSelf Evaluation (SSE) Questionnaire** **(Cosmetic Appeal)**

n  **DermatologicalEvaluation : Safety**

n  **DermatologicalEvaluation : Skin softness**

n   **Corneometry**

n   **Tewametry**

Study Population :

**33 femalesubjects** ***are selected forthe stud***

***The subjectsselected for this study are healthy females, aged between 18 and 40 years,*** **having** dry skinon inner forearms with corneometer reading of <30.

**Study Duration :**(Screeningperiod to Last-Patient-Out) (A+B+D): 37 days

**Study Duration** (First-Patient-Into Last-Patient-Out) (B+D): 23 days

***A= Screening period***(Period for identification of eligible 33subjects): 14 days

***B= Enrollment period*** (Period for conductingbaseline visits of 33 subjects): 21 days

***C= Run-in period:***Not applicable

***D= Treatment period per patient:***2 days

Study will be carried out on the randomized 3sites of 3x3 cm2 marked areas on the right inner forearms; product Aand product B will be applied at two sites (one test product per site) and onesite will serve as untreated control.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 33

Inclusion Criteria

1.Indian female subjects 2.Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup) 3.Between 18 and 40 years of age.
4.Skin is healthy on the studied anatomic unit (e.g., free of eczema, wounds, inflammatory scar).
5.Having dry skin on inner forearms with corneometry reading of <30.

Exclusion Criteria

1.For Female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
2.Having started, changed or stopped a hormonal treatment (e.g., hormonal contraception, Hormonal Replacement Therapy, thyroid) in the past 3 months 3.Having taken an oral retinoid-based treatment in the past 6 months.
4.Having had a local retinoid-based treatment on the studied areas in the previous month.
5.Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask) in the previous week 6.Having applied a moisturizing product on the studied areas in the 5 days preceding the start of the study.
(only hands cleaned with water is accepted) 7.Having practiced water activities (swimming pool, sauna, hammam, baleneotherapy etc.) in the previous week 8.Having consumed caffeine-based products (coffee, cola, tea), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements 9.Having practiced intensive sports during the day prior to the T0 measurements 10.Having wounds, Scars, sunburns, tattoos and piercing on test site.
11.Having applied another product than water on the studied areas in the morning of the T0 measurements 12.Having had an intensive UV exposition on the forearms (solariums, sun) during 5 days prior to T0 measurements.
13.Having used any skin care products as well as skin care cleansers such as bath/shower oils on the forearms during 5 days prior to T0 measurements.
14.Having hair on test site.
15.Refusing to follow the restrictions below during the study: Do not take part in any family planning activities leading to pregnancy and breastfeeding , Do not take part in another study liable to interfere with this study , Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol), During the study: Do not use other cosmetic products than the tested product to the studied areas., Do not have beauty treatment (e.g. scrub, manicure self-tanning product) , Do not practice water activities (swimming pool, sauna, hammam, balneotherapy etc.), Do not drink/ eat caffeine-based products (coffee, cola, tea), alcohol, highly spiced food, nor smoke , Do not practice sport , Do not apply any product on inner forearms including water., Do not wipe their inner forearms., Do not wear jewels on the wrists, Do not have an intensive UV exposition on the inner forearms (solariums, sun).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent improvement in capacitance value i.e skin moisturization	30 minutes, 2 hours, 4 hours, 6 hours, 8 hours & 24 hours after product application

Secondary Outcome Measures

Name	Time	Method
Percent reduction in transepidermal water loss (TEWL), Percent improvement in skin softness , safety of Product	30 minutes, 2 hours, 4 hours, 6 hours, 8 hours & 24 hours after product application

Trial Locations

Locations (1): Mascot Spincontrol India Pvt. Ltd.
🇮🇳
Mumbai, MAHARASHTRA, India
Mascot Spincontrol India Pvt. Ltd.
🇮🇳Mumbai, MAHARASHTRA, India
Dr Raji Patil
Principal investigator
02243349191
raji@mascotspincontrol.in