A clinical study to evaluate the safety & efficacy of test product in Healthy Female subjects

Completed

• Conditions: Healthy Human Adult Females aged 21 to 50 years

• Registration Number: CTRI/2023/06/053620
• Lead Sponsor: DPKA Universal Consumer Venture Private Limited

Brief Summary

This is clinical and consumer study to assess safety, efficacy, and shortterm

consumer benefits of clay- mask in healthy female subjects.

The rationale of the product testing is to evaluate the effectiveness of the clay mask in terms of

sebum reduction, improvement in skin texture and tone while maintaining the skin hydration.

The acceptability of the clay mask will also be determined by self-evaluation questionnaires.

The expected study duration of this study will be a maximum of 03 days

from enrolment

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-06-22
• Study Start: 2023-06-26
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 53

Inclusion Criteria

• 1. Age: 21 to 50 years (both inclusive) old at the time of consent.
• 2. Sex: Healthy human non-pregnant/non-lactating females.
• 3. Frequent users of international brands.
• 4. Females of childbearing potential must have a self-reported negative urine pregnancy test.
• 5. Subjects are generally in good general health as determined from recent medical history.
• 6. The subject is willing and able to follow the study directions, participate in the study, returning for all specified visits.
• 7. The subject must be able to understand and provide written informed consent to participate in the study.

Exclusion Criteria

• Subjects must not be enrolled in the study if they meet any one of the following criteria: 1) Subject with known allergy or sensitization to cosmetic products.
• 2. The subject has clinically significant skin disease, which may contraindicate participation, including psoriasis, eczema, Skin cancer or other skin pathology.
• 3. Medication which may affect skin response and/or past medical history.
• 4. Individuals with active (flaring) disease or chronic skin allergies (atopic dermatitis/eczema) or those who have recently undergone treatment for skin cancer (within the last 12 months) in the area of testing on the forehead, nose and the cheeks.
• 5. Female volunteers who have started a new hormonal birth control agent or switched to a hormonal birth control agent within the past 60 days.
• 6. Individuals who have had any medical or cosmetic procedure, such as laser resurfacing, or plastic surgery to the test site (face) within the last 6 months.
• This includes botulinum toxin, dermal fillers, collagen or other similar cosmetic procedure.
• 7. Individuals who are currently using or during the past 14 days have used a retinoid such as tretinoin, adapalene, or retinol containing agents or a hydroquinone containing agent.
• 8. Individuals who have used mineral clay masks on their face within the last 14 days.
• 9. Individuals who have been on any topical prescribed medications for the past 2 weeks.
• 10. An individual who has a medical condition or is taking or has taken a medication which, in the Investigator’s judgment, makes the subject ineligible or places the subject at undue risk.
• 11. Participation in other clinical studies simultaneously.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in skin hydration	From Baseline to Day 01 & Day 03
3. Change in Sebum Secretion	From Baseline to Day 01 & Day 03
4. Change in number of pores, visible pores area, & clogged pores	From Baseline to Day 01 & Day 03
2. Change in Skin Radiance	From Baseline to Day 01 & Day 03
5. Improvement in visible pores area	From Baseline to Day 01 & Day 03

Secondary Outcome Measures

Name	Time	Method
To evaluate the product effectiveness in terms of subject response	index
Change in facial Photographs	From Baseline to Day 01

Trial Locations

Locations (1)

NovoBliss Research Pvt. Limited; 🇮🇳 Gandhinagar, GUJARAT, India

NovoBliss Research Pvt. Limited

🇮🇳Gandhinagar, GUJARAT, India

Dr Nayan Patel

Principal investigator

9909013286

dr.nayan@novobliss.in