A clinical study to assess the safety, in-use tolerability of test product in healthy adult subjects with dry and sensitive skin.

Not Applicable

• Registration Number: CTRI/2024/07/070558
• Lead Sponsor: Kayura Effect LLP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1)Age: 18 to 55 years (both inclusive) at the time of consent.

2)Sex: Healthy male and non-pregnant/non-lactating females. (Preferably equal ratio of males and females)

3)Females of childbearing potential must have a self-reported negative pregnancy test.

4)Subject are generally in good health.

5)Subject with dry and sensitive skins. (As per the dermatological evaluation).

6)Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.

7)If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.

8)Subjects are willing to give written informed consent and are willing to come for regular follow up.

9)Subjects who commit not to use medicated skincare products other than the test product for the entire duration of the study.

10)Subject who have not participated in a similar investigation in the past three months.

11)Willing to use test product throughout the study period.

Exclusion Criteria

1)History of any dermatological condition of the skin disease.

2)Subject with present condition of allergic response to any cosmetic product.

3)Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.

4)History of alcohol or drug addiction.

5)The subject has clinically significant skin disease, which may contraindicate participation, including psoriasis, eczema, skin cancer or other skin pathology.

6)Subjects having skin infections like bacterial, fungal, viral infections.

7)The subject has skin irritation, open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the face that can interfere with the reading.

8)Be wearing any facial makeup, including false eyelashes, on the day of the study visit.

9)Subjects having hypersensitive skin.

10)Subjects using other marketed sun screen products during the study period.

11)Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.

12)Pregnant or breastfeeding or planning to become pregnant during the study period.

13)History of chronic illness which may influence the cutaneous state.

14)Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified