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.
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.
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).
Crossover
Active Comparator- Xtressé™ Supplement and Serum
Dietary supplementParticipants 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 supplementParticipants 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.
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.
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.
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.
Increase in hair density as measured by SOCAi
Changes to the appearance of hair will be captured using the SOCAi system.
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.
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The Center for Clinical and Cosmetic Research
Lead sponsor
Restore Biologics Holdings, Inc. dba Xtressé
Collaborator
Xtressé (TM)
Collaborator
