Efficacy and Tolerability of a Scalp Serum

June 3, 2026 updated by: Revision Skincare

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measurement of Clinical Efficacy by Trichogram Imaging
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measurement of scalp health to achieve microbiome friendly claim
Time Frame: Baseline, week 4, and week 12.

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.
Baseline, week 4, and week 12.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-assessment Questionnaires for Scalp Conditions
Time Frame: Baseline, weeks 4, 8, and 12
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Revision Skincare

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dermico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 19, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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