Efficacy and Tolerability of a Scalp Serum

NCT07500623 | Completed

• 1 other identifier: RS-2024-01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hair Thinning

Keywords

scalp; hair thinning; hair loss; scalp health; scalp microbiome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measurement of scalp health by skin microbiome testing

  Baseline, week 4, and week 12.

Other Outcomes (1)

• Self-assessment Questionnaires for Scalp Conditions

  Baseline, weeks 4, 8, and 12

Study Arms (1)

Scalp Regimen

EXPERIMENTAL

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

Interventions

Scalp Serum OTHER

Scalp Serum was applied once-daily directly onto the scalp on wet or dry hair in either the morning or evening.

Scalp Regimen

Eligibility Criteria

• Age: 25 Years - 65 Years
• Gender Eligibility Details: The study was conducted on biological women as this was part of inclusion criteria.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Revision Skincare: lead
• Dermico: collaborator
• Hellobiome: collaborator

Study Sites (1)

Dermico

Broomall, Pennsylvania, 19008, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 30, 2026
• Study Start: February 19, 2024
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2024
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)