An interventional study of Scalp Serum in Hair Thinning, sponsored by Revision Skincare. Completed at 1 site in United States. Open to female participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Revision Skincare · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to evaluate the efficacy and tolerability of a scalp serum on 60 healthy females aged 25 to 65 years with Fitzpatrick skin phototypes I-VI and with mild to moderate thinning hair. The primary objective is to evaluate if the scalp serum can achieve fuller and thicker hair with fewer signs of hair shedding from baseline. The second objective is to evaluate if the scalp serum enhances scalp health including optimizing the pH and supporting microbiome at Week 4 and Week 12 compared to baseline (post-washout period).
Subjects will apply a scalp serum once-daily to wet or dry hair in either the morning or evening for 12 weeks. Prospective Candidates will attend a Pre-Study Visit (PSV) at the lab to be consented. After being accepted onto the study, Volunteers will be told to stop the use of all products on their scalp and hair (shampoo, conditioner, oils, dyes etc.) other than the Sponsor-provided Ancillary Products (APs) and their regularly used, non-medicated styling products for the seven (7) days prior to Visit 1/Baseline (V1/BL) and for the duration of the study. Subjects will return to clinic for study visits at weeks 4, 8, and 12.
At V1(baseline), Subjects will have their hair combed and the shed hairs collected. They will then report to a Dermatologist, who will make BL evaluations of Redness, Dryness, Flaking, and Bumps. Subjects will then be asked to rate the Itching, Burning, and Stinging of their scalp. A Technician will clip an area of hair and take photographs of the area for trichoscopy analysis. Photographs of the Subject's scalp with hair parted down the middle will also be taken. Ultrasound, Laser Doppler, pH, and Moisture measurements will be taken from their scalp. Subjects will then have microbiome samples collected from their scalp via swabbing, and a subset of five (5) Subjects will have 2mm punch biopsies collected from their scalp behind one of their ears. A Technician will provide the Subject with the Investigational Product (IP), Subject Instructions (including treatment instructions), and a Daily-Use Diary before applying the product under supervision. Subjects will then complete a self-assessment questionnaire (SAQ) before their visit ends.
Subjects will report to the study site for Visit 2 (V2), approximately 48 hours after their BL appointment (BL +2D) and will have the clipped area of their scalp photographed again for trichoscopy.
At Visit 3 (V3), Subjects will report to the study site approximately 4 weeks (W4) after their initial BL visit. At this visit, the same measurements, photographs, and assessments will be performed as at the BL visit, except for biopsy collection. Subject's IP will be weighed, their Daily-Use Diary will be reviewed, and they will apply the IP under supervision before completing an SAQ. After these procedures, the Subjects will leave the study site.
Subjects will report to the study site for Visit 4 (V4), approximately 48 hours after their W4 appointment (W4 +2D) and will have the clipped area of their scalp photographed again for trichoscopy.
At Visit 5 (V5), Subjects will report to the study site approximately 8 weeks (W8) after their initial BL visit. At this visit, the same dermatological and Subject assessments, as well as photography and shedding analysis, will be performed as at the BL visit. No instrumental measurements, microbiome swabbing, or biopsy collection will be performed at this visit. Subject's IP will be weighed, their Daily-Use Diary will be reviewed, and they will apply the IP under supervision before completing an SAQ. After these procedures, the Subjects will leave the study site.
Subjects will report to the study site for Visit 6 (V6), approximately 48 hours after their W8 appointment (W8 +2D) and will have the clipped area of their scalp photographed again for trichoscopy.
At Visit 7 (V7), Subjects will report to the study site approximately 12 weeks (W12) after their initial BL visit. At this visit, the same measurements, photographs, and assessments will be performed as at the BL visit, including biopsy collection. Subject's IP will be weighed, and the Daily-Use Diary will be reviewed and collected. Subjects will take a final SAQ.
Subjects will report to the study site for Visit 8 (V8), approximately 48 hours after their W12 appointment (W12 +2D) and will have the clipped area of their scalp photographed again for trichoscopy. Subjects who participate in the biopsy subset and receive sutures will need to return for suture removal and examination of the site by the study Dermatologist approximately 2 weeks after each visit where sutures were placed (BL and/or W12). Subject's participation in the study will end.
511 studies on the registry are indexed under Alopecia; 128 are open to participants now.
This study's enrollment of 57 is above the median of 50 across 430 interventional studies indexed under Alopecia.
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Exclusion Criteria:
Subjects were provided with a shampoo and conditioner (TRESemmé Flawless Curls, Suave Lush \& Coily, or Suave Rose Oil Infusion) to be used up to three times per week and instructed to stop the use of all scalp and hair products for 7 days.
Other: Scalp Serum
Scalp Serum was applied once-daily directly onto the scalp on wet or dry hair in either the morning or evening.
Measurement of Clinical Efficacy by Trichogram Imaging
A digital trichoscope was used to take images of the subjects scalp which were analyzed for hair density and hair thickness. An increase in score/ value indicates an improvement.
Time frame: Baseline, Baseline +2 days, Week 4, Week 4 + 2 days, Week 8, Week 8 + 2 days, Week 12, and Week 12 + 2 Days
Measurement of scalp health to achieve microbiome friendly claim
Microbiome samples were collected from the center of the top of the scalp, with the hair parted in the middle by each subject following Hellobiome kit instructions. Hellobiome microbiome collection kits and analysis was supplied by ELSI SKIN HEALTH, Inc (San Francisco, CA, USA). An outcome measure to achieve microbiome friendly claim is indicated by a shift in the microbial population, increase in bacteria:fungi ratio, increase in bacterial and fungal load, increase in fungal diversity, a shift in bacterial community, but no significant changes in the fungal composition.
Time frame: Baseline, week 4, and week 12.
Self-assessment Questionnaires for Scalp Conditions
At baseline and weeks 4, 8 and 12, subjects completed a Sponsor-provided self-assessment questionnaire. Subjects reviewed each statement and circled the following: Completely Agree (5), Slightly Agree (4), Neither Agree or Disagree (3), Slightly Disagree (2), Completely Disagree (1). A greater percent of subjects scoring 4 and 5 on each question indicates an improvement at post-baseline timepoints compared to baseline.
Time frame: Baseline, weeks 4, 8, and 12
Plan to share: No
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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