Efficacy and Tolerability of a Scalp Serum

12-week Evaluation of the Efficacy and Tolerability of a Scalp Serum Study

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.

Study Overview

• Status: Completed
• Conditions: Hair Thinning
• Intervention / Treatment: Other: Scalp Serum

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Broomall, Pennsylvania, United States, 19008
      • Dermico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• biological females
• 25 to 65 years old
• Fitzpatrick Skin Type I - VI
• Mild to moderate thinning hair (Ludwig score of I-1 through I-4)

Exclusion Criteria:

• Active scalp disease
• Prior use of medicated shampoos or topical scalp treatments within 12 months.
• Diagnosis of female pattern hair loss or other alopecia disorders, or use of medications, supplements, or procedures known to affect the hair growth cycle.
• Pregnancy or breastfeeding, planned pregnancy during the study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Scalp Regimen; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Baseline +2 days, Week 4, Week 4 + 2 days, Week 8, Week 8 + 2 days, Week 12, and Week 12 + 2 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of scalp health by skin microbiome testing	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).	Baseline, week 4, and week 12.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, weeks 4, 8, and 12

Collaborators and Investigators

• Sponsor: Revision Skincare
• Collaborators: Hellobiome; Dermico

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Actual): May 20, 2024
• Study Completion (Actual): May 20, 2024

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: hair loss; scalp; hair thinning; scalp health; scalp microbiome
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia
• Other Study ID Numbers: RS-2024-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No