Scalp HealthNCT06985121
Scalp Care Efficacy Evaluation for Premium Scalp Revitalizing Essence
A study testing Base formula only, Base formula plus IGF-1 and FGF-7 and Base formula plus Centella asiatica extracellular vesicles in people with Scalp Health and Hair Condition, run by Hungkuang University at 1 site in Taiwan.
Trial summary
The study aims to evaluate the efficacy of the Premium Scalp Revitalizing Essence on human scalp skin. A total of 60 healthy adults, aged 18 to 60, will be recruited and randomly assigned into five groups receiving different formulations. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Scalp Health, Hair Condition, Hair Loss
- What is being tested?
- Base formula only, Base formula plus IGF-1 and FGF-7 and Base formula plus Centella asiatica extracellular vesicles
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Apr 2025to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy adults of any gender from the age of 18 to 60 years (inclusive).
- Absence of chronic diseases, major illnesses, or allergies.
- Major illnesses include cancer, post-stroke disorders, paralysis, acute myocardial infarction, coro-nary artery bypass surgery, end-stage renal disease, and major organ transplant or hematopoietic stem cell transplant
Who cannot join
- Currently taking any medication or using any scalp care products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Scalp Skin Care Effects of Premium Scalp Revitalizing Essence、Premium Scalp Revitalizing Essence 2、Premium Scalp Revitalizing Essence 3
The study aims to evaluate the efficacy of the Premium Scalp Revitalizing Essence on human scalp skin. A total of 60 healthy adults, aged 18 to 60, 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.
Read the detailed description
This is a prospective, randomized, double-blinded, and placebo-controlled study to investigate the effects of Premium Scalp Revitalizing Essence on changes in the skin texture of human scalp skin.
Sixty healthy adults aged from 18 to 60 will be recruited and randomly assigned into five groups, with 12 individuals in each group. Group 1 uses Placebo (Base formula without caffeine and panthenol); Group 2 uses the Base formula (Control with caffeine and panthenol); Group 3 uses Base + IGF-1 \& FGF-7; Group 4 uses Base + Centella asiatica extracellular vesicles; Group 5 uses Base + Centella Asiatica Exosome + IGF-1 \& FGF-7. Before using the test product, all 60 participants undergo the first scalp skin texture test. After 14 days of using the test product, a second scalp skin texture test is conducted; after 28 days of use, a third test is performed; after 42 days of use, a fourth test is conducted; and after 56 days of use, a fifth test is carried out. The scalp skin texture tests include measurements of skin (1) sebum content, (2) overall hair loss, (3) hair density, (4) scalp condition, (5) hair length, and other parameters. The Sebumeter® SM815 probe of the MPA580 device and the ScalpX Intelligent Scalp Diagnostic System will be used to measure the parameters of the study.
- Conditions
- Scalp Health, Hair Condition, Hair Loss, Sebum Production, Hair and Scalp Health
- Being tested
- Placebo control, Base formula only, Base formula plus IGF-1 and FGF-7, Base formula plus Centella asiatica extracellular vesicles, Base formula plus Centella asiatica extracellular vesicles, IGF-1 & FGF-7
- Keywords
- Scalp care, Hair loss, Skin texture, Sebum measurement, Scalp condition, Hair length, Hair density, Cosmetics, Product formulation, Growth factor, Centella asiatica, Extracellular vesicles
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo controlOther
Placebo control (base formula without caffeine and panthenol). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.
Base formula onlyOther
Base formula consisting of active ingredients caffeine and panthenol. Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.
Base formula plus IGF-1 and FGF-7Other
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.
Base formula plus Centella asiatica extracellular vesiclesOther
Base formula plus Centella asiatica extracellular vesicles. Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.
Base formula plus Centella asiatica extracellular vesicles, IGF-1 & FGF-7Other
Base formula plus Centella asiatica 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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Placebo control | Placebo comparator | Base formula without caffeine and panthenol Receives: Other: Placebo control |
| Group 2: Base formula only | Experimental | Base formula consisting of active ingredients caffeine and panthenol (vitamin B5). Receives: 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) Receives: Other: Base formula plus IGF-1 and FGF-7 |
| Base formula plus Centella asiatica extracellular vesicles | Experimental | Base formula plus Centella asiatica extracellular vesicles Receives: Other: Base formula plus Centella asiatica extracellular vesicles |
| Group 5: Base formula plus Centella asiatica extracellular vesicles, IGF-1 & FGF-7. | Experimental | Base formula plus Centella asiatica extracellular vesicles, insulin growth factor-1 (IGF-1) and fibroblast growth factor-7 (FGF-7). Receives: Other: Base formula plus Centella asiatica extracellular vesicles, IGF-1 & FGF-7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. The change in light transmission corresponds to the amount of sebum on the tape and is displayed on a scale from 0 to 350 units.
Measured: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
Hair length
Hair length (cm): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex).
Measured: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
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).
Measured: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
Hair thickness
Hair thickness (micrometers): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex).
Measured: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
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.
Measured: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start8 Apr 2025
- Primary completion18 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scalp HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hungkuang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsong-Min Chang, Hungkuang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985121
- Sponsor's protocol ID
- 25-016-A
- Status last verified
- Jun 2025
- First submitted
- 20 May 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Scalp Skin Care Effects of Premium Scalp Revitalizing Essence、Premium Scalp Revitalizing Essence 2、Premium Scalp Revitalizing Essence 3
- ClinicalTrials.gov ID
- NCT06985121
- Acronym / sponsor ID
- 25-016-A
- Conditions
- Scalp Health, Hair Condition, Hair Loss, Sebum Production, Hair and Scalp Health
- Keywords
- Scalp care, Hair loss, Skin texture, Sebum measurement, Scalp condition, Hair length, Hair density, Cosmetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hungkuang UniversityUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to evaluate the efficacy of the Premium Scalp Revitalizing Essence on human scalp skin. A total of 60 healthy adults, aged 18 to 60, 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.
Detailed description
This is a prospective, randomized, double-blinded, and placebo-controlled study to investigate the effects of Premium Scalp Revitalizing Essence on changes in the skin texture of human scalp skin.
Sixty healthy adults aged from 18 to 60 will be recruited and randomly assigned into five groups, with 12 individuals in each group. Group 1 uses Placebo (Base formula without caffeine and panthenol); Group 2 uses the Base formula (Control with caffeine and panthenol); Group 3 uses Base + IGF-1 \& FGF-7; Group 4 uses Base + Centella asiatica extracellular vesicles; Group 5 uses Base + Centella Asiatica Exosome + IGF-1 \& FGF-7. Before using the test product, all 60 participants undergo the first scalp skin texture test. After 14 days of using the test product, a second scalp skin texture test is conducted; after 28 days of use, a third test is performed; after 42 days of use, a fourth test is conducted; and after 56 days of use, a fifth test is carried out. The scalp skin texture tests include measurements of skin (1) sebum content, (2) overall hair loss, (3) hair density, (4) scalp condition, (5) hair length, and other parameters. The Sebumeter® SM815 probe of the MPA580 device and the ScalpX Intelligent Scalp Diagnostic System will be used to measure the parameters of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1: Placebo control | Placebo comparator | Other: Placebo controlBase formula without caffeine and panthenol |
| Group 2: Base formula only | Experimental | Other: Base formula onlyBase formula consisting of active ingredients caffeine and panthenol (vitamin B5). |
| Group 3: Base formula plus IGF-1 & FGF-7. | Experimental | Other: Base formula plus IGF-1 and FGF-7Base formula plus insulin growth factor 1 (IGF-1) and fibroblast growth factor-7 (FGF-7) |
| Base formula plus Centella asiatica extracellular vesicles | Experimental | Other: Base formula plus Centella asiatica extracellular vesiclesBase formula plus Centella asiatica extracellular vesicles |
| Group 5: Base formula plus Centella asiatica extracellular vesicles, IGF-1 & FGF-7. | Experimental | Other: Base formula plus Centella asiatica extracellular vesicles, IGF-1 & FGF-7Base formula plus Centella asiatica extracellular vesicles, insulin growth factor-1 (IGF-1) and fibroblast growth factor-7 (FGF-7). |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Healthy adults of any gender from the age of 18 to 60 years (inclusive).
- Absence of chronic diseases, major illnesses, or allergies.
- Major illnesses include cancer, post-stroke disorders, paralysis, acute myocardial infarction, coro-nary artery bypass surgery, end-stage renal disease, and major organ transplant or hematopoietic stem cell transplant
Key exclusion criteria (1 listed)
- Currently taking any medication or using any scalp care products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo controlPlacebo control (base formula without caffeine and panthenol). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days. | Other | Group 1: Placebo control |
| Base formula onlyBase formula consisting of active ingredients caffeine and panthenol. Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days. | Other | Group 2: Base formula only |
| Base formula plus IGF-1 and FGF-7Base 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. | Other | Group 3: Base formula plus IGF-1 & FGF-7. |
| Base formula plus Centella asiatica extracellular vesiclesBase formula plus Centella asiatica extracellular vesicles. Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days. | Other | Base formula plus Centella asiatica extracellular vesicles |
| Base formula plus Centella asiatica extracellular vesicles, IGF-1 & FGF-7Base formula plus Centella asiatica 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. | Other | Group 5: Base formula plus Centella asiatica extracellular vesicles, IGF-1 & FGF-7. |
Primary outcome
Sebum Content
Time frame: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
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. The change in light transmission corresponds to the amount of sebum on the tape and is displayed on a scale from 0 to 350 units.
Hair length
Time frame: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
Hair length (cm): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex).
Hair density
Time frame: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
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).
Hair thickness
Time frame: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
Hair thickness (micrometers): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex).
Hair loss
Time frame: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
Related trials for Scalp Health
Active, not recruiting
Evaluation of the Scalp Skin Care Effects of Premium Revitalizing Elixir and Topical 5% Minoxidil
Scalp Health, Alopecia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Base formula only, Base formula plus IGF-1 and FGF-7 and Base formula plus Centella asiatica extracellular vesicles in people with Scalp Health and Hair Condition, run by Hungkuang University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sebum Content (time frame: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.