Xtressé Supplement and Serum for Alopecia

Recruiting at 1 trial location

Overseen By Mark S. Nestor, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: The Center for Clinical and Cosmetic Research

Must not be taking: Hormonal therapy, Hair loss treatments

Disqualifiers: Pregnancy, Hormonal changes, Uncontrolled conditions, others

Compensation: Varies

Number of Visits: 7

85 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new gummy and serum treatment, Xtressé™ Supplement and Serum, which aims to improve hair growth in women experiencing thinning hair. The study compares this active treatment with a placebo to determine any noticeable differences in hair growth using photos and personal feedback. Women who have consistently experienced hair thinning and can maintain their current lifestyle habits during the study may be suitable candidates. Participants will begin with either the active treatment or placebo for three months, then switch to the active treatment for an additional six months.

As an unphased trial, this study allows participants to contribute to early-stage research and potentially benefit from innovative hair growth solutions.

Do I need to stop taking my current medications for the trial?

You can continue taking your current medications as long as you agree to maintain them throughout the study. However, if you are using certain hair loss treatments or hormonal therapies, you may need to stop those before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Xtressé™ Supplement and Serum, designed for hair growth, is generally safe. Early studies, including a small initial study, suggested that this gummy supplement does not cause major side effects. The treatment targets the main causes of hair loss in women, and past results indicate it may promote hair growth without serious problems.

Although this specific trial lacks safety data, its occurrence suggests some confidence in the treatment's safety. Xtressé™ is being tested with the expectation that any side effects will be mild, particularly for conditions like hair loss. Individual experiences can vary, and participation in a clinical trial ensures close monitoring for any unexpected issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Xtressé™ because, unlike typical alopecia treatments like minoxidil or finasteride, it combines a supplement and a serum approach to tackle hair loss. This dual method aims to nourish hair both from within and externally, potentially offering a more comprehensive solution. Additionally, Xtressé™ may work through unique active ingredients not found in conventional treatments, providing a fresh avenue of hope for those struggling with hair loss. This innovative approach could offer a new angle in alopecia care by addressing multiple pathways to promote healthy hair growth.

What evidence suggests that the Xtressé™ Supplement and Serum might be an effective treatment for alopecia?

Research has shown that the Xtressé™ Supplement and Serum combination may help women with thinning hair grow thicker hair. In earlier studies, women using this treatment noticed their hair appeared fuller and denser. Improvements were measured on a scale from 0 (none) to 4 (very severe), and those using the active products experienced positive changes. In this trial, participants in the intervention group will receive the Xtressé™ supplements and serum, while the placebo group will initially receive placebo supplements and serum. These early results suggest that Xtressé™ might boost hair growth and make thinning hair less noticeable. However, results can vary, and further research is underway to confirm these effects. ^{1 2 3 5 6}

Who Is on the Research Team?

Danielle Leavitt

Principal Investigator

Restore Biologics Holdings, Inc. dba Xtressé

Are You a Good Fit for This Trial?

This trial is for women experiencing self-perceived thinning hair. Participants will need to attend 6 to 7 visits over a period of 9 months. The study excludes specific details on eligibility criteria, but typically includes age range, general health requirements, and the absence of conditions that could interfere with the treatment or skew results.

Inclusion Criteria

Fitzpatrick Skin Types I to VI

I am a woman aged 28-65 experiencing hair thinning.

Ludwig Scale I or II (mild to moderate thinning hair loss), assessed clinically

Exclusion Criteria

I do not have uncontrolled health issues like thyroid disease or anemia.

Known sensitivity to any of the ingredients in the study medication

Treatment with an experimental drug, biologic or device within 12 weeks of the screening visit

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment Part A

Participants receive either active or placebo treatment for 3 months

3 months

3-4 visits (in-person)

Treatment Part B

All participants receive active treatment for 6 months

6 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Xtressé™ Supplement and Serum

Trial Overview The trial tests an active gummy and serum combination (Xtressé™) against a placebo version for promoting hair growth in women. It's split into two parts: Part A has random assignment to active/inactive treatments for three months; Part B gives all participants the active treatment for six more months.

How Is the Trial Designed?

Group I: Intervention Group - Part A and Part B Active Control 1 Intervention

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.

Group II: Placebo Group- Part B Active Control 1 Intervention

42 subjects will enter the open-labelled Part B of the study and will receive Xtressé™ supplements + serum.

Group III: Placebo Group- Part A Placebo Group 1 Intervention

42 subjects will be randomized to this group and will receive Placebo supplements and serum in only Part A of the study.

Who Is Running the Clinical Trial?

The Center for Clinical and Cosmetic Research

Lead Sponsor

Trials

8

Recruited

340+

Xtressé (TM)

Collaborator

Restore Biologics Holdings, Inc. dba Xtressé

Industry Sponsor

Restore Biologics Holdings, LLC

Collaborator

Citations

1. patlynk.com patlynk.com/trial/NCT07041489

Xtressé™ Supplement and Serum Treatment for Hair ... This study aims to explore the effectiveness and safety of a combination treatment involving Xtressé™ supplement and serum to promote hair growth in women ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07041489

Evaluating the Combined Use of Supplement and Serum in ... 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.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT07041489/evaluating-the-combined-use-of-supplement-and-serum-in-promoting-hair-growth-in-women-with-self-perceived-thinning-hair?page=5&id=661&slug=hair-loss

Evaluating the Combined Use of Supplement and Serum in ... 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 ...

4. researchgate.net researchgate.net/publication/393955758_A_Pilot_Investigation_of_a_Gummy-Based_Hair_Nutraceutical_Preliminary_Efficacy_Findings

A Pilot Investigation of a Gummy-Based Hair Nutraceutical These preliminary findings suggest stronger efficacy of Xtressé™ in female pattern hair loss or self‐perceived thinning, with less robust outcomes observed ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07041489?term=SEARCH%5BLocation%5D(AREA%5BLocationCountry%5DUnited%20States)&rank=9

Evaluating the Combined Use of Supplement and Serum in ... 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.

6. withpower.com withpower.com/trial/phase-alopecia-4-2025-1bd3e

Xtressé Supplement and Serum for Alopecia ... Xtressé™ Supplement and Serum will have tolerable side effects & efficacy for patients with Alopecia and Periprosthetic Bone Loss. See if you qualify today!