A Clinical Study to Assess the Safety, In-use Tolerability of Test Product in Healthy Adult Subjects With Dry and Sensitive Skin.

NCT ID: NCT06489600

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-19
• Study Completion Date: 2025-01-04

Brief Summary

This is open-label, interventional, prospective, safety in-use tolerability study of test product "No Rays, Thanks Mineral Sunscreen" in healthy adult human subjects with dry and sensitive skin.

Detailed Description

A total of 27 subjects with preferably equal number of males and non-pregnant /non-lactating females will be enrolled to ensure a total of 25 subjects complete the study.

The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called on the telephone by the recruiting department prior to the enrolment visit. Subjects will be told during screening (prior to enrolment) not to wear any facial make-up on the study visit day. The adult male and female subjects will be instructed to visit the facility as per the below visits.

• Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation, on site product usage, Post usage evaluation at T15 mins.
• Visit 02 (Day 15 ±2 Days): Evaluations, End of Study

Conditions

Dry Skin; Sensitive Skin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

No Rays, Thanks Mineral sunscreen

Wash your face with standard facewash and apply a pea size amount on the face in the morning.

Group Type: EXPERIMENTAL

No Rays, Thanks Mineral sunscreen

Intervention Type: OTHER

Wash your face with standard facewash and apply a pea size amount on the face in the morning.

Dosage form: semi-solid frequency: Once in a day Route of Administration: Topical

Interventions

No Rays, Thanks Mineral sunscreen

Wash your face with standard facewash and apply a pea size amount on the face in the morning.

Dosage form: semi-solid frequency: Once in a day Route of Administration: Topical

Intervention Type: OTHER

Eligibility Criteria

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.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kayura Effects LLP

UNKNOWN

Sponsor Role: collaborator

NovoBliss Research Pvt Ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Nayan K Patel

Role: PRINCIPAL_INVESTIGATOR

NovoBliss Research Pvt Ltd

Locations

NovoBliss Research Pvt.Ltd

Ahmedabad, Gujarat, India

Countries

India

Other Identifiers

NB240031-KE

Identifier Type: -

Identifier Source: org_study_id