Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT07228156
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-24
First Post:
2025-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate Xtresse Serum in Individuals With Thinning Hair
Sponsor:
Restore Biologics Holdings, Inc. dba Xtressé
Organization:
Study Overview
Official Title:
Pilot Study to Evaluate the Efficacy and Safety of Xtresse FR Concentrate Serum in Individuals With Self-Perceived Thinning Hair.
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to determine how safe and effective it is to improve hair growth by applying a serum daily on the scalp of men and women with thinning hair.
The main aims of this trial are:
1. To confirm using photographic analysis, changes in the quality, volume, and thickness of hair.
2. To gauge patient satisfaction with hair changes and application process.
3. Monitor and report any adverse events associated with the daily usage of Xtressé serum.
Participants who qualify will complete 4 visits after voluntary consent has been given. Participants will be given 4 bottles of serum to use during the study. The product will be applied daily over a 4-month period. Photographs and scalp analysis will be performed at each visit to measure changes in hair volume, thickness, and growth. Participants will complete a survey at the end of the study.
The main aims of this trial are:
1. To confirm using photographic analysis, changes in the quality, volume, and thickness of hair.
2. To gauge patient satisfaction with hair changes and application process.
3. Monitor and report any adverse events associated with the daily usage of Xtressé serum.
Participants who qualify will complete 4 visits after voluntary consent has been given. Participants will be given 4 bottles of serum to use during the study. The product will be applied daily over a 4-month period. Photographs and scalp analysis will be performed at each visit to measure changes in hair volume, thickness, and growth. Participants will complete a survey at the end of the study.
Detailed Description:
In the study, participants will be asked to complete the following:
* Provide basic personal information (including date of birth, gender, race and ethnicity)
* Provide their medical/ surgical history and perform a medical exam (including but not limited to symptom-directed physical exam, skin type, vital signs, height, weight, and pregnancy test)
* Follow study rules such as avoiding certain medications and treatments
* Provide information on any medications, treatments or reactions that started after the study began
* Apply serum daily and complete a treatment log
* Allow clinical assessments and documentation of the treatment, such as photography, hair density measurements, any reactions or side effects
To qualify for this trial, participants must:
* Be an adult between ages of 18-65
* Have consistent self-perceived thinning hair.
* Give voluntary written consent
* Be willing to follow study instructions and complete study requirements, including maintaining current diet and hair care routine, not using non-approved lotions and creams on the treatment areas
* Allow photographs of the front and top area of the scalp
* Not be pregnant or breast feeding before and during the study and agree to use acceptable forms of birth control
* Confirm they are not sensitive to any of the study treatment ingredients
All photographs of the treatment area collected during the study will be used as study data.
All participants have the right to refuse further participation in the study at any time.
* Provide basic personal information (including date of birth, gender, race and ethnicity)
* Provide their medical/ surgical history and perform a medical exam (including but not limited to symptom-directed physical exam, skin type, vital signs, height, weight, and pregnancy test)
* Follow study rules such as avoiding certain medications and treatments
* Provide information on any medications, treatments or reactions that started after the study began
* Apply serum daily and complete a treatment log
* Allow clinical assessments and documentation of the treatment, such as photography, hair density measurements, any reactions or side effects
To qualify for this trial, participants must:
* Be an adult between ages of 18-65
* Have consistent self-perceived thinning hair.
* Give voluntary written consent
* Be willing to follow study instructions and complete study requirements, including maintaining current diet and hair care routine, not using non-approved lotions and creams on the treatment areas
* Allow photographs of the front and top area of the scalp
* Not be pregnant or breast feeding before and during the study and agree to use acceptable forms of birth control
* Confirm they are not sensitive to any of the study treatment ingredients
All photographs of the treatment area collected during the study will be used as study data.
All participants have the right to refuse further participation in the study at any time.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: