Evaluating the Combined Use of Supplement and Serum in Promoting Hair Growth in Women With Self-perceived Thinning Hair

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
The Center for Clinical and Cosmetic Research
Study ID
NCT07041489
Status
Recruiting
Apply to this trial

Conditions

  • Hair Thinning

Eligibility Criteria

Sex
FEMALE
Age
28 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Active Comparator- Xtressé™ Supplement and Serum — DIETARY_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 Serum — DIETARY_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 Details

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.

Key Dates

Start date
May 20, 2025
Status verified
Jun 2025
Primary completion
Mar 20, 2026
Completion
Mar 30, 2026

Study Design

Enrollment
85 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Intervention Group - Part A and Part B
    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.
  • Placebo Comparator: Placebo Group- Part A
    42 subjects will be randomized to this group and will receive Placebo supplements and serum in only Part A of the study.
  • Active Comparator: Placebo Group- Part B
    42 subjects will enter the open-labelled Part B of the study and will receive Xtressé™ supplements + serum.

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Skin Wellness DermatologyBirminghamAlabama35209
Clinical Coordinator
(205) 871-7332
Corey L. Hartman, MD, FAAD (PRINCIPAL_INVESTIGATOR)
Center for Clinical and Cosmetic ResearchAventuraFlorida33180
Clinical Coordinator
[email protected]
305-933-6716
Mark S. Nestor, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Skin Wellness Dermatology· Birmingham, ALCenter for Clinical and Cosmetic Research· Aventura, FL

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