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Clinical Trials/CTRI/2024/08/072157
CTRI/2024/08/072157
Completed
Not Applicable

A clinical study to evaluate the protective effect of the test product against environmental pollution on the skin along with its safety on healthy adult female subjects.

Zydus Wellness Products Limited1 site in 1 country36 target enrollmentStarted: August 23, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
1
Primary Endpoint
To assess the efficacy of test product on pollution-induced skin damages, based on clinical, instrumental and subjective evaluations done at predetermined time points.

Overview

Brief Summary

This is an open label, non-randomized, single-centre, single arm clinical study to evaluate the protective effect of the test product against environmental pollution on the skin along with its safety on healthy adult female subjects.

The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.

All eligible subjects will undergo clinical evaluation by a Dermatologist, instrument evaluation and subjective evaluation. Safety will be assessed throughout the study by monitoring adverse events.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 45.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Subjects who have lived in high air pollution areas for at least the past 5 years / have been occupationally exposed to high air pollution for the past 2 years.
  • Subjects with visible blackheads on the face.
  • Subjects with at least 2 blemishes, uneven skin tone and visible redness on face.
  • Subjects willing to provide written informed consent to participate in the study.

Exclusion Criteria

  • Subjects using any other face wash during the study period.
  • Subjects who are receiving topical or systemic treatments for pigmentation within the last 30 days.
  • Subjects having any active dermatological skin diseases (e.g., psoriasis, atopic dermatitis, rosacea etc.), that might interfere with clinical assessments.
  • Subjects participating in other similar cosmetic or therapeutic study within last four weeks.

Outcomes

Primary Outcomes

To assess the efficacy of test product on pollution-induced skin damages, based on clinical, instrumental and subjective evaluations done at predetermined time points.

Time Frame: Day 01, Day 07, Day 14, Day 21 and Day 28.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other [Health and Hygiene]
Responsible Party
Principal Investigator
Principal Investigator

Dr Bhagirath Patel

Cliantha Research

Study Sites (1)

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