Restore Biologics Holdings, Inc. dba Xtressé
The goal of this study is to determine how much Xtresse' gummy taken daily changes hair density in women with self-perceived thinning hair compared with placebo. Thirty-patients will be randomly assigned to receive either Xtresse' active gummy or placebo. Neither staff not participant will know which treatment is given. The mains aims of this trial are: 1. To confirm using photographic analysis , changes in terminal hair density. 2. To confirm using photographic analysis, changes in total hair density and hair shaft size. 3. To gauge patient satisfaction with hair changes and application process. Participants who qualify will complete 3 in-person visits. Participants will be given a 90-day supply of the gummies at visit 1 (after voluntary consent is given) and visit 2 to cover the 6-month study period. Photographs and scalp analysis will be performed at each visit to measure changes in hair volume, thickness, and growth.
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) Follow study rules such as avoiding certain medications and treatments Provide information on any medications, treatments or reactions that started after the study began Take active or placebo gummy treatment daily and complete a treatment diary Allow clinical assessments…
Inclusion Criteria: * Self-perceived thinning hair, confirmed by the investigator as Ludwig I or II * Fitzpatrick skin types I to IV * Stable thinning for at least 6 months * No use of other hair loss treatment during participation. Stopped prior -treatments 3-6 months before participation. * Willing to keep hair, length, color, and style comparable through Day 180. * Willing to use contraception through day 180 if or childbearing potential. * Able to attend all in-person study visits Exclusion Criteria: * Scalp disease that is clinically significant, involves the target area, or would inte…
The nutraceutical supplement is powered by proprietary X-3 BioActive Blend and contains plant based extracts and regenerative compounds not commonly found in existing hair supplements. The dosage is 2 gummies taken once per day.
The placebo supplement will contain no active ingredients. Participants will receive 3 month supply 2 times during the study. Participants will take 2 supplements daily.
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