Hair ThinningNCT07041489
Evaluating the Combined Use of Supplement and Serum in Promoting Hair Growth in Women With Self-perceived Thinning Hair
A study testing Active Comparator- Xtressé™ Supplement and Serum in people with Hair Thinning, run by The Center for Clinical and Cosmetic Research at 2 sites in United States.
Trial summary
The goal of this clinical trial is to test how safe and effective it is to improve hair growth using an active gummy and serum combination treatment when compared to an inactive treatment combination in women with self-perceived thinning hair. Read more about this study
- Who is it for?
- Ages 28 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hair Thinning
- What is being tested?
- Active Comparator- Xtressé™ Supplement and Serum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 May 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 28 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female adults between 28-65 years of age with consistent self-perceived thinning hair.
- Ludwig Scale I or II (mild to moderate thinning hair loss), assessed clinically.
- Fitzpatrick Skin Types I to VI.
- Agree to maintain their current diet, medications, exercise routines, hair shampooing, and color treatment frequency for the duration of the study.
- Ability and willingness to comply with the study protocol including regular visits and product application.
- Written informed consent obtained, including written consent to allow photographs to be used as part of the study data and documentation.
- For females of childbearing potential, a negative pregnancy test at screening and commitment to effective contraception throughout the study (oral / implant/ injectable/ transdermal contraceptives, intrauterine device, condom, diaphragm, abstinence, or a monogamous relationship with a partner who has had a vasectomy) to avoid pregnancy-related hormonal changes affecting hair density.
Who cannot join
- Pregnant or lactating or planning to become pregnant.
- Changes in hormonal therapy within 6 months prior to enrollment and throughout the study.
- Use of other medical hair loss treatments (e.g., Minoxidil, Dutasteride, Finasteride, laser or light therapy) within 3 months prior to study start and throughout the study.
- Micro-needling, PRP, or any other physical treatment modality on the scalp (within 6 months prior to study start and throughout the study).
- Use of GLP-1 inhibitors (e.g., Semaglutide) within 6 months prior to study start and throughout the study.
- Known uncontrolled health conditions (e.g., thyroid disease, anemia) that could confound study outcomes.
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- Known sensitivity to any of the ingredients in the study medication.
- In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions and requirements of the protocol and complete the study.
- Subject has any conditions, findings in history, physical exam or laboratory assessments, which in the opinion of the investigator, would exclude the subject from continuing in this study.
- Treatment with an experimental drug, biologic or device within 12 weeks of the screening visit.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
Clinical Coordinator, 305-933-6716, info@centerforclinicalandcosmeticresearch.com
Mark S. Nestor, MD, PhD
- Recruiting
Skin Wellness Dermatology
Birmingham, Alabama, 35209
Clinical Coordinator, (205) 871-7332
Corey L. Hartman, MD, FAAD
About this study
Official title: A Multi Center, Randomized, Double-Blind, Placebo-controlled Trial With Extension to an Open-Label Study to Evaluate the Safety and Efficacy of Xtressé™ Supplement + Serum Treatment Combination in Promoting Hair Growth in Women With Self-perceived Thinning Hair
The goal of this clinical trial is to test how safe and effective it is to improve hair growth using an active gummy and serum combination treatment when compared to an inactive treatment combination in women with self-perceived thinning hair.
The main questions this trial aims to answer are:
Read more
- to confirm using photograph analytics, how much hair growth has increased in a marked area when using active treatment versus inactive treatment, and
- participants assessment and satisfaction with the hair growth using scaled assessments.
Participants who qualify will be asked to complete 6 to 7 visits after voluntarily consent has been given. The study is divided into two parts. In Part A participants will be randomly given either active or inactive treatment to use over 3 months. After 3 months, all participants will enter Part B of the study and will be given active treatment to use over the final 6 months of the study.
Read the 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, laboratory assessments and pregnancy test collection)
- 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 and take gummy treatment daily, including completing a treatment diary
- 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 a female adult between 28 to 65 years of age
- 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 treatments 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
A relatively small area will be shaved off-center and top of the scalp for a dot-tattoo placement and this marked area will be used for clinical assessments throughout the study.
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.
- Conditions
- Hair Thinning
- Being tested
- Active Comparator- Xtressé™ Supplement and Serum, Placebo Comparator- Placebo Supplement and Serum
- Keywords
- hair thinning, thinning hair, hair loss, thin hair
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator- Xtressé™ Supplement and SerumDietary supplement
Participants will receive 3 month supplies 3 times during the study. Participants will apply serum and take supplements daily.
Participants in the Intervention group will receive Xtressé™ Supplements and Serum in Part A and Part B of the study.
Participants in the Placebo Group will receive Xtressé™ Supplement and Serum in Part B of the study only.
Placebo Comparator- Placebo Supplement and SerumDietary supplement
Participants will receive 3 month supplies 3 times during the study. Participants will apply serum and take supplements daily.
Participants in the Placebo Group will receive Placebo Supplement and Serum in Part A of the study only.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - Part A and Part B | Active comparator | 43 subjects will be randomized to this group and will receive Xtressé™ supplements + serum during the double-blinded Part A and open-label Part B of the study. Receives: Dietary Supplement: Active Comparator- Xtressé™ Supplement and Serum |
| Placebo Group- Part A | Placebo comparator | 42 subjects will be randomized to this group and will receive Placebo supplements and serum in only Part A of the study. Receives: Dietary Supplement: Placebo Comparator- Placebo Supplement and Serum |
| Placebo Group- Part B | Active comparator | 42 subjects will enter the open-labelled Part B of the study and will receive Xtressé™ supplements + serum. Receives: Dietary Supplement: Active Comparator- Xtressé™ Supplement and Serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in hair density (hairs per cm²) measured as the within-subject change from baseline to Month 3, assessed via Canfield HairMetrix® phototrichogram analyses.
Quantitative hair measurements calculated by analyzing the participants digital images.
Measured: an average of 3 months
Increase in hair density (hairs per cm²) Measured as the within-subject change from baseline to Month 9, assessed via Canfield HairMetrix® phototrichogram analyses.
Quantitative hair measurements calculated by analyzing the participants digital images.
Measured: Up to 9 months
Participant self-assessment of hair growth and satisfaction, collected via validated questionnaires.
Observations and changes noted in hair loss graded on a scale of 0 to 4, with 0 as none and 4 as a very severe outcome.
Observations and changes noted in quality of life based on hair loss, outcomes graded between extremely affected and not at all.
Measured: Up to 9 months
Secondary outcomes (2)
Increase in hair density as measured by SOCAi
Changes to the appearance of hair will be captured using the SOCAi system.
Measured: Up to 9 months
Improvements in hair quality (e.g., thickness, strength) and volume, evaluated by blinded investigator assessments
Observations and changes noted in hair quality graded on a scale of -3 to +3, with -3 as greatly worsened/ decreased, 0 as no change and +3 as significantly increased/ improved.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start20 May 2025
- Primary completion20 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair ThinningStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Center for Clinical and Cosmetic Research
- Sponsor type
- University, hospital or other
- Collaborators
- Restore Biologics Holdings, Inc. dba Xtressé, Xtressé (TM)
- Responsible party
- Sponsor
- Investigators
- Danielle Leavitt, Study director, Restore Biologics Holdings, Inc. dba Xtressé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041489
- Sponsor's protocol ID
- CCCR 03-2025
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Center, Randomized, Double-Blind, Placebo-controlled Trial With Extension to an Open-Label Study to Evaluate the Safety and Efficacy of Xtressé™ Supplement + Serum Treatment Combination in Promoting Hair Growth in Women With Self-perceived Thinning Hair
- ClinicalTrials.gov ID
- NCT07041489
- Acronym / sponsor ID
- CCCR 03-2025
- Conditions
- Hair Thinning
- Keywords
- hair thinning, thinning hair, hair loss, thin hair
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- The Center for Clinical and Cosmetic ResearchUniversity, hospital or other
- Collaborators
- Restore Biologics Holdings, Inc. dba Xtressé, Xtressé (TM)
- Study start
- 20 May 2025 (actual)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 27 Jun 2025 (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.
The goal of this clinical trial is to test how safe and effective it is to improve hair growth using an active gummy and serum combination treatment when compared to an inactive treatment combination in women with self-perceived thinning hair.
The main questions this trial aims to answer are:
- to confirm using photograph analytics, how much hair growth has increased in a marked area when using active treatment versus inactive treatment, and
- participants assessment and satisfaction with the hair growth using scaled assessments.
Participants who qualify will be asked to complete 6 to 7 visits after voluntarily consent has been given. The study is divided into two parts. In Part A participants will be randomly given either active or inactive treatment to use over 3 months. After 3 months, all participants will enter Part B of the study and will be given active treatment to use over the final 6 months 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, laboratory assessments and pregnancy test collection)
- 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 and take gummy treatment daily, including completing a treatment diary
- 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 a female adult between 28 to 65 years of age
- 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 treatments 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
A relatively small area will be shaved off-center and top of the scalp for a dot-tattoo placement and this marked area will be used for clinical assessments throughout the study.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - Part A and Part B | Active comparator | Dietary Supplement: Active Comparator- Xtressé™ Supplement and Serum43 subjects will be randomized to this group and will receive Xtressé™ supplements + serum during the double-blinded Part A and open-label Part B of the study. |
| Placebo Group- Part A | Placebo comparator | Dietary Supplement: Placebo Comparator- Placebo Supplement and Serum42 subjects will be randomized to this group and will receive Placebo supplements and serum in only Part A of the study. |
| Placebo Group- Part B | Active comparator | Dietary Supplement: Active Comparator- Xtressé™ Supplement and Serum42 subjects will enter the open-labelled Part B of the study and will receive Xtressé™ supplements + serum. |
Who may qualify
- Ages
- 28 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female adults between 28-65 years of age with consistent self-perceived thinning hair.
- Ludwig Scale I or II (mild to moderate thinning hair loss), assessed clinically.
- Fitzpatrick Skin Types I to VI.
- Agree to maintain their current diet, medications, exercise routines, hair shampooing, and color treatment frequency for the duration of the study.
- Ability and willingness to comply with the study protocol including regular visits and product application.
Key exclusion criteria (10 listed)
- Pregnant or lactating or planning to become pregnant.
- Changes in hormonal therapy within 6 months prior to enrollment and throughout the study.
- Use of other medical hair loss treatments (e.g., Minoxidil, Dutasteride, Finasteride, laser or light therapy) within 3 months prior to study start and throughout the study.
- Micro-needling, PRP, or any other physical treatment modality on the scalp (within 6 months prior to study start and throughout the study).
- Use of GLP-1 inhibitors (e.g., Semaglutide) within 6 months prior to study start and throughout the 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 |
|---|---|---|
| Active Comparator- Xtressé™ Supplement and SerumParticipants will receive 3 month supplies 3 times during the study. Participants will apply serum and take supplements daily. Participants in the Intervention group will receive Xtressé™ Supplements and Serum in Part A and Part B of the study. Participants in the Placebo Group will receive Xtressé™ Supplement and Serum in Part B of the study only. | Dietary supplement | Intervention Group - Part A and Part B, Placebo Group- Part B |
| Placebo Comparator- Placebo Supplement and SerumParticipants will receive 3 month supplies 3 times during the study. Participants will apply serum and take supplements daily. Participants in the Placebo Group will receive Placebo Supplement and Serum in Part A of the study only. | Dietary supplement | Placebo Group- Part A |
Primary outcome
Increase in hair density (hairs per cm²) measured as the within-subject change from baseline to Month 3, assessed via Canfield HairMetrix® phototrichogram analyses.
Time frame: an average of 3 months
Quantitative hair measurements calculated by analyzing the participants digital images.
Increase in hair density (hairs per cm²) Measured as the within-subject change from baseline to Month 9, assessed via Canfield HairMetrix® phototrichogram analyses.
Time frame: Up to 9 months
Quantitative hair measurements calculated by analyzing the participants digital images.
Participant self-assessment of hair growth and satisfaction, collected via validated questionnaires.
Time frame: Up to 9 months
Observations and changes noted in hair loss graded on a scale of 0 to 4, with 0 as none and 4 as a very severe outcome. Observations and changes noted in quality of life based on hair loss, outcomes graded between extremely affected and not at all.
2 secondary outcomes
Increase in hair density as measured by SOCAi
Time frame: Up to 9 months
Improvements in hair quality (e.g., thickness, strength) and volume, evaluated by blinded investigator assessments
Time frame: Up to 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
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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.
Danielle Leavitt study director
Restore Biologics Holdings, Inc. dba Xtressé
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator- Xtressé™ Supplement and Serum in people with Hair Thinning, run by The Center for Clinical and Cosmetic Research at 2 sites 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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark S. Nestor, MD, PhD (305-933-6716, info@centerforclinicalandcosmeticresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in hair density (hairs per cm²) measured as the within-subject change from baseline to Month 3, assessed via Canfield HairMetrix® phototrichogram analyses. (time frame: an average of 3 months). The study lists 3 primary outcomes in all. 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 27 Jun 2025.