Hair ThinningNCT07500623
Efficacy and Tolerability of a Scalp Serum
A study testing Scalp Serum in people with Hair Thinning, run by Revision Skincare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Hair Thinning
- What is being tested?
- Scalp Serum
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2024to 20 May 2024
- 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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hair Thinning
- Being tested
- Scalp Serum
- Keywords
- scalp, hair thinning, hair loss, scalp health, scalp microbiome
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalp SerumOther
Scalp Serum was applied once-daily directly onto the scalp on wet or dry hair in either the morning or evening.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Scalp Serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 to achieve microbiome friendly claim
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.
Measured: Baseline, week 4, and week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start19 Feb 2024
- Primary completion20 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair ThinningStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revision Skincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dermico
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500623
- Sponsor's protocol ID
- RS-2024-01
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12-week Evaluation of the Efficacy and Tolerability of a Scalp Serum Study
- ClinicalTrials.gov ID
- NCT07500623
- Acronym / sponsor ID
- RS-2024-01
- Conditions
- Hair Thinning
- Keywords
- scalp, hair thinning, hair loss, scalp health, scalp microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Revision SkincareIndustry (pharma, biotech, devices)
- Collaborators
- Dermico
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 30 Mar 2026 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scalp Regimen | Experimental | Other: Scalp SerumSubjects 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Scalp SerumScalp Serum was applied once-daily directly onto the scalp on wet or dry hair in either the morning or evening. | Other | Scalp Regimen |
Primary outcome
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.
1 secondary outcome
Measurement of scalp health to achieve microbiome friendly claim
Time frame: Baseline, week 4, and week 12.
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 5 Jun 2026.
- Individual participant dataSharing planned: No
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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 Scalp Serum in people with Hair Thinning, run by Revision Skincare at 1 site in United States.
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 4 inclusion and 4 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 5 Jun 2026. 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 United States. 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. 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?
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). 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 5 Jun 2026.