Scalp Care Efficacy Evaluation for Premium Revitalizing Elixir

NCT07271212 | Active Not Recruiting

• 1 other identifier: 25-090-A
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the efficacy of the Premium Revitalizing Elixir on human scalp skin. A total of 60 healthy adults, aged 18 to 60 with alopecia, baldness, or self-identified with symptoms of hair thinning will be recruited and randomly assigned into five groups receiving different formulations. Participants will use the product once daily for 56 days, and their scalp conditions will be assessed through skin texture tests at multiple time points. Key parameters such as sebum content, overall hair loss, hair density, scalp condition, and hair length will be measured. A self-assessment and assessment by a hair specialist on hair and scalp condition will also be provided at the end of the study (Day 56).

Conditions

Scalp Health; Hair Condition; Hair Loss; Alopecia; Sebum Production; Hair Health; Hair Thinning

Keywords

Scalp care; Hair loss; Alopecia; Skin texture; Sebum measurement; Hair thinning; Scalp condition; Extracellular vesicles; Growth factors; Centella asiatica; Ginger; Cosmetics; hair density; Product formulation

Outcome Measures

Primary Outcomes (5)

• Sebum Content

  Assess oil levels on the scalp at standardized scalp sites (left, right, and vertex). Measured with C+K Multi Probe Adaptor MPA580 system using the Sebumeter® SM815 probe based on the grease spot photometry method with the sebum measurement cassette tape.

  Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)

• Hair length

  Hair length (cm): Measured manually with ruler at standardized scalp sites (left, right, and vertex).

  Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)

• Hair density

  Hair density (number of hairs/cm-square): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex).

  Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)

• Hair thickness

  Hair thickness (micrometers): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex).

  Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)

• Hair loss

  Hair loss: Assessed by the standardized hair combing test by counting the number of hairs shed after the participants' hair was combed over a clean surface for 60 strokes.

  Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)

Secondary Outcomes (2)

• Participant self-assessment

  Day 56 (End of the study period)

• Hair specialist assessment

  Day 56 (End of the study)

Study Arms (5)

Group 1: Placebo control

PLACEBO COMPARATOR

Base formula without caffeine and panthenol

Other: Placebo control

Group 2: Base formula only

EXPERIMENTAL

Base formula consisting of active ingredients 0.1% caffeine and panthenol (vitamin B5).

Other: Base formula only

Group 3: Base formula plus IGF-1 & FGF-7.

EXPERIMENTAL

Base formula plus insulin growth factor 1 (IGF-1) and fibroblast growth factor-7 (FGF-7)

Other: Base formula plus IGF-1 and FGF-7

Group 4: Base formula plus Centella asiatica and ginger extracellular vesicles

EXPERIMENTAL

Base formula plus Centella asiatica and ginger (Zingiber officinale) extracellular vesicles

Other: Base formula plus Centella asiatica and ginger extracellular vesicles

Group 5: Base formula plus Centella asiatica and ginger extracellular vesicles, IGF-1 & FGF-7.

EXPERIMENTAL

Base formula plus Centella asiatica and ginger (Zingiber officinale) extracellular vesicles, insulin growth factor-1 (IGF-1) and fibroblast growth factor-7 (FGF-7).

Other: Base formula plus Centella asiatica and ginger extracellular vesicles, IGF-1 & FGF-7

Interventions

Base formula plus Centella asiatica and ginger extracellular vesicles, IGF-1 & FGF-7 OTHER

Base formula plus Centella asiatica and ginger extracellular vesicles, insulin growth factor-1 (IGF-1) and fibroblast growth factor-7 (FGF-7). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.

Group 5: Base formula plus Centella asiatica and ginger extracellular vesicles, IGF-1 & FGF-7.

Placebo control OTHER

Placebo control (base formula without caffeine and panthenol). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.

Group 1: Placebo control

Base formula only OTHER

Base formula consisting of active ingredients 0.1% caffeine and panthenol. Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.

Group 2: Base formula only

Base formula plus Centella asiatica and ginger extracellular vesicles OTHER

Base formula plus Centella asiatica and ginger extracellular vesicles. Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.

Group 4: Base formula plus Centella asiatica and ginger extracellular vesicles

Base formula plus IGF-1 and FGF-7 OTHER

Base formula plus insulin growth factor 1 (IGF-1) and fibroblast growth factor-7 (FGF-7). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.

Group 3: Base formula plus IGF-1 & FGF-7.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults of any gender from the age of 18 to 60 years (inclusive).
• Having symptoms of alopecia, baldness, or self-identified with hair thinning.
• Absence of chronic diseases, major illnesses, or allergies.
• Major illnesses include cancer, post-stroke disorders, paralysis, acute myocardial infarction, coronary artery bypass surgery, end-stage renal disease, and major organ transplant or hematopoietic stem cell transplant

You may not qualify if:

• Currently taking any medication or using any scalp care products
• Pregnant or breastfeeding
• Chronic diseases, significant illnesses, or allergic constitutions
• Currently using scalp care products
• Students or employees affiliated with the principal investigator,
• Individuals with scalp wounds
• Participated in cosmetic product testing
• Undergone scalp aesthetic treatments within the past three months.

Sponsors & Collaborators

• Hungkuang University: lead
• Schweitzer Biotech Company: collaborator

Study Sites (1)

Hungkuang University

Taichung, 433304, Taiwan

Location

MeSH Terms

Conditions

Alopecia

Interventions

Insulin-Like Growth Factor I; Centella asiatica extract

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Somatomedins; Insulin-Like Peptides; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Blood Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 9, 2025
• Study Start: November 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-11

Locations

TW (1)