Skin HealthNCT06452810
A Clinical Trial to Evaluate the Effects of a Skin Balm on the Appearance of the Eye Area
A study testing Experimental: Sahajan Golden Glow Balm in people with Skin Health, run by Sahajan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Health
- What is being tested?
- Experimental: Sahajan Golden Glow Balm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Feb 2024to 3 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Medical conditions affecting skin health
- Use of medications or products that could affect skin health
- Pregnancy or breastfeeding
- Participation in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Skin Health
- Being tested
- Experimental: Sahajan Golden Glow Balm
- Keywords
- Eye Balm, Periorbital area, Dermatology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Sahajan Golden Glow BalmDietary supplement
Participants will apply the Sahajan Golden Glow Balm twice daily (morning and night) to the periorbital area following the specified instructions.
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Experimental | All participants in this arm will receive the Sahajan Golden Glow Balm and will follow the same intervention protocol. Receives: Dietary Supplement: Experimental: Sahajan Golden Glow Balm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Health and Appearance of the Skin in the Periorbital Area
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.
Measured: Baseline to Week 6
Secondary outcomes (1)
Changes in Participants' Perception of the Appearance of the Skin in the Periorbital Area
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.
Measured: Baseline, Day 1, Week 2, Week 4, and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start29 Feb 2024
- Primary completion3 May 2024
- Study completion3 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study Type: Interventional (Clinical Trial) Estimated Enrollment: 35 participants Allocation: Non-randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahajan
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452810
- Sponsor's protocol ID
- 20407
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with study participants and published in open-access preprint servers following study completion and analysis.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Effects of a Skin Balm on the Appearance of the Eye Area
- ClinicalTrials.gov ID
- NCT06452810
- Acronym / sponsor ID
- 20407
- Conditions
- Skin Health
- Keywords
- Eye Balm, Periorbital area, Dermatology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- SahajanIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 3 May 2024 (actual)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study Type: Interventional (Clinical Trial) Estimated Enrollment: 35 participants Allocation: Non-randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
| Arm | Type | Receives |
|---|---|---|
| Single Group | Experimental | Dietary Supplement: Experimental: Sahajan Golden Glow BalmAll participants in this arm will receive the Sahajan Golden Glow Balm and will follow the same intervention protocol. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Medical conditions affecting skin health
- Use of medications or products that could affect skin health
- Pregnancy or breastfeeding
- Participation in another clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Sahajan Golden Glow BalmParticipants will apply the Sahajan Golden Glow Balm twice daily (morning and night) to the periorbital area following the specified instructions. | Dietary supplement | Single Group |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: Yes. Data will be shared with study participants and published in open-access preprint servers following study completion and analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Sahajan Golden Glow Balm in people with Skin Health, run by Sahajan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Health and Appearance of the Skin in the Periorbital Area (time frame: Baseline to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.