A Clinical Trial to Evaluate the Effects of a Skin Balm on the Appearance of the Eye Area

June 10, 2024 updated by: Sahajan
This virtual single-group clinical trial aims to evaluate the effects of the Sahajan Golden Glow Balm on the health and appearance of the skin in the periorbital area over a period of 6 weeks. Participants will apply the product twice daily and complete questionnaires at various intervals. Photos for expert skin grading will be taken at Baseline and Week 6.

Study Overview

Status

Completed

Conditions

Detailed Description

The study will investigate the impact of Sahajan Golden Glow Balm on skin health, particularly focusing on fine lines, wrinkles, dark circles, and dry eyes. It involves 35 female participants aged 35 and above, who will use the product for 6 weeks and complete periodic questionnaires and provide photos for dermatological assessment.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Santa Monica, California, United States, 90404
        • Citruslabs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Concerns with the appearance of skin in the periorbital area
  • Willing to maintain the same skincare routine for the study duration
  • Must own a smartphone or digital camera for photos

Exclusion Criteria:

  • Medical conditions affecting skin health
  • Use of medications or products that could affect skin health
  • Pregnancy or breastfeeding
  • Participation in another clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Group
All participants in this arm will receive the Sahajan Golden Glow Balm and will follow the same intervention protocol.
Participants will apply the Sahajan Golden Glow Balm twice daily (morning and night) to the periorbital area following the specified instructions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the Health and Appearance of the Skin in the Periorbital Area
Time Frame: Baseline to Week 6
The primary outcome measure will assess changes in the health and appearance of the skin in the periorbital area, evaluated via expert skin grading by a board-certified dermatologist.
Baseline to Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Participants' Perception of the Appearance of the Skin in the Periorbital Area
Time Frame: Baseline, Day 1, Week 2, Week 4, and Week 6
The secondary outcome measure will evaluate changes in participants' perception of the appearance of their skin in the periorbital area, including the appearance of fine lines, wrinkles, dark circles, and dry skin, using participant-reported questionnaires.
Baseline, Day 1, Week 2, Week 4, and Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 29, 2024

Primary Completion (Actual)

May 3, 2024

Study Completion (Actual)

May 3, 2024

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 20407

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared with study participants and published in open-access preprint servers following study completion and analysis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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