- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06452810
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
Intervention / Treatment
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.
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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
Keywords
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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