Efficacy and Tolerability of a Scalp Serum

Part of paid clinical trials in Broomall, Pennsylvania.

Sponsor
Revision Skincare
Study ID
NCT07500623
Status
Completed

Conditions

  • Hair Thinning

Eligibility Criteria

Sex
FEMALE
Age
25 Years - 65 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Feb 19, 2024
Status verified
Mar 2026
Primary completion
May 20, 2024
Completion
May 20, 2024

Study Design

Enrollment
57 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
DermicoBroomallPennsylvania19008-

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