Effectiveness and Safety of Cellbooster Hair in Healthy Subjects

November 5, 2026 updated by: Suisselle

A Prospective, Open Study on the Safety and Effectiveness of CellBooster® Hair

Cellbooster® Hair (CBH) is a class III medical device, CE marked, HA-based injectable using the patented CHAC Technology. It consists of stabilized Hyaluronic Acid 18mg (6mg/ml) with Amino Acids and Vitamins, and minerals (zinc, copper). The medical device is designed for strengthening hair follicles, improving hair growth and microcirculation. It restores scalp skin structure and provides hair fiber restructuring. The device is a resorbable injectable implant for preventing and treating various scalp and hair problems linked to hormonal imbalance, psoriasis, seborrhea, stress, nutrition and trace elements deficiencies, such as: hair loss, hair breakage, scalp dehydration, dandruff, premature graying. The device improves microcirculation, restores scalp skin structure and other qualities, provides hair fiber restructuring after physical and/or chemical damage, such as: hair dying, permanent wave, sun, dryer.

The current post-market clinical investigation aims to evaluate the efficacy and safety of CBH in the scalp of subjects. For this purpose, healthy subjects with signs of hair loss will receive a 6-session treatment spaced every 2 weeks and will be followed-up over 130 days after the initial injection session. Objective measurements of scalp function and hair characteristics parameters will be performed allowing to assess hair density, hair diameter, hair structure, scalp hydration, scalp barrier function and thickness and having illustrative pictures. Subjective clinical improvement will be evaluated with clinical scoring, as well as subject and investigator satisfaction degrees. The safety of the injections will be assessed by collecting the Injection Site Reactions (ISRs) and Adverse Events (AEs).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Nina Nguon, PhD, Global Scientific, Medical & Clinical Affairs Lead
  • Phone Number: +41 78 320 90 92
  • Email: nina.nguon@suisselle.com

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy subject.
  2. Sex: male and female.
  3. Phototype I to IV.
  4. Age: from 18 years old.
  5. Subject with low to moderate capillary density: - Male with hair loss grade II to IV on Hamilton scale modified by Norwood - Female with hair loss grade I to II on Ludwig scale
  6. Proportion of hair in telogen phase ≥ 20% for the men and ≥ 15% for the women.
  7. Subject with a total hair density ≥ 150 hair/cm² on test area.
  8. Agreeing to have one shaved zone of 1.5cm X 1.2cm on the scalp (vertex area) during the study for hair assessments.
  9. With dark brown or black hair at the root.
  10. With hair length > 3 cm on vertex, and agreeing to keep this defined minimum length during the whole study duration.
  11. Subject requiring an aesthetic treatment for reduced hair quality and hair density.
  12. Subject willing to abstain from other scalp and hair aesthetic procedure through the entire study duration.
  13. Subject agreeing to keep the same hair cut during all the study.
  14. Subject having given their free, express, and informed consent.
  15. Subject psychologically able to understand the information related to the study, and to give their written informed consent.
  16. Subject registered to a social security scheme.
  17. Female of childbearing potential must use a medically accepted contraceptive method since at least 12 weeks before the beginning of the study and throughout the study.
  18. Female subjects of childbearing potential must have a negative pregnancy test at the inclusion.

Exclusion Criteria:

In terms of population

  1. Pregnant or nursing woman or planning a pregnancy during the study.

  2. Studied zone with white or blond hair (coloured white hair also excluded to avoid affecting the PTG count).

  3. With hair coloured, bleached at the root or permed.

  4. Subject wearing a wig.

  5. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.

  6. Subject in a social or sanitary establishment.

  7. Subject participating in another research on human beings or being in an exclusion period for a previous study.

  8. Intensive exposure to sunlight or UV-rays within the previous month and/or planning to do so during the study.

    In terms of associated pathology

  9. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results and/or subject safety at the investigator appreciation.

  10. Subject having history of severe allergy or anaphylactic shock.

  11. Subject having history of allergy or hypersensitivity to one of the components of the tested device and or to any excipient of Xylocaine®

  12. Subject having history of hypersensitivity to the antiseptic solution.

  13. Subject with known history of or suffering from autoimmune disease and/or immune deficiency.

  14. Dermatological scalp disorders (ex: psoriasis, scalp dermatitis including seborrheic dermatitis, eczema, pre-cancerous or cancerous lesions, alopecia areata, fungal or bacterial infection, ringworm, lice or flea infestation) or poor hygiene.

  15. Suffering from alopecia of special origins: chemotherapy induced (intoxication, drugs), or result from a chronic disease (genetic, endocrinological (excluding androgenetic alopecia)), immunological deficiencies…), result from injury or skin damage, alopecia of infectious origin (mycosis,…), scarring alopecia, psychological disorders (trichotillomania, trichokryptomania).

  16. Subject with any form of bleeding disorders.

  17. Subject with varices on the area (scalp).

  18. Subject with inflammation or infection on the scalp.

  19. Subject predisposed to keloids or hypertrophic scarring or having healing disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CBH
Device: Scalp booster injection (CBH)

Eligible subjects will receive six intradermal treatment sessions with CBH, administered at 14-day intervals on Days 0, 14, 28, 42, 56 and 70.

CellBooster® Hair (CBH) Class III medical device Composition non-crosslinked Sodium Hyaluronate 18 mg;

  • amino acids (Arginine, Cysteine, Glutamine, Glycine, Lysine);
  • vitamins (Niacin, Pantothenic Acid, Pyridoxine, Biotin, Cyanocobalamin, Rutin);
  • Copper Gluconate, Zinc Carbonate;
  • phosphate buffer pH 6.8-7.6 q.s.
Other Names:
  • Cellbooster Hair scalp injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline of hair density (total number of hair in the studied zone) at Day 130 evaluated by Phototrichogram (PTG) analysis
Time Frame: Day 130
Day 130

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline of hair diameter at Day 130 evaluated by Phototrichogram (PTG) analysis
Time Frame: Day 130
Day 130
Change from baseline of hair loss at Day 130 evaluated by Phototrichogram (PTG) analysis : percentage of telogen hair (%T)
Time Frame: Day 130
Day 130
Change from baseline of hair loss at Day 130 evaluated by Phototrichogram (PTG) analysis : anagen hair density (DA), telogen hair density (DT)
Time Frame: Day 130
Day 130
Change from baseline of hair loss at Day 130 evaluated by Phototrichogram (PTG) analysis : anagen to telogen ratio (DA/DT)
Time Frame: Day 130
Day 130
Change from baseline of hair average roughness (Ra), quadratic mean (Rq), maximum relief amplitude (Rt) and average relief (Rz) at Day 130 evaluated by MiniSurf® (only on subjects with hair length>10 cm).
Time Frame: Day 130
Day 130
Change from baseline of scalp skin hydration at Day 35 and Day 130 evaluated by Corneometer® on shaved area.
Time Frame: Day 35 and Day 130
Day 35 and Day 130
Change from baseline of scalp skin trans epidermal water loss (TEWL) at Day 35 and Day 130 evaluated by Aquaflux® on shaved area.
Time Frame: Day 35 and Day 130
Day 35 and Day 130
Change from baseline of scalp dermis thickness and density (ratio non-echogenic surface/total surface) at Day 35 and Day 130 evaluated by DermaScan® 2D on shaved area.
Time Frame: Day 35 and Day 130
Day 35 and Day 130
Proportion of subjects having an improvement with CBH treatment as assessed by the investigator at Day 35 and Day 130, using the Investigator Global Assessment (IGA).
Time Frame: Day 35 and Day 130

An improvement is defined as subject having a score "very much improved", "much improved" or "improved" on the Investigator Global Assessment (IGA)

4-grade scale: 1: Strongly disagree 2: Disagree 3: Agree 4: Strongly
Day 35 and Day 130
Illustration of the device effect on hair loss with standardized photos of the vertex and after standardized shampoo/cut/brush at Day 0, Day 35 and Day 130.
Time Frame: Day 0, Day 35 and Day 130
Day 0, Day 35 and Day 130
Degree of satisfaction of the injectors through the answers to a subjective evaluation questionnaire completed for each subject after each three injection session (Day 28 and Day 70).
Time Frame: Day 28 and Day 70

For each question, the percentage of answers "agree" or "totally agree" will be computed

5-grade scale: Strongly disagree ; 1 : Disagree ; 2 : Neither agree nor disagree ; 3 : Agree ; 4 : Strongly agree
Day 28 and Day 70
Degree of satisfaction of the subjects through the answers to a subjective evaluation questionnaire at Day 35 and Day 130. For each question, the percentage of subject satisfied, (percentages of answers "agree" or "totally agree") will be computed.
Time Frame: Day 35 and Day 130
Day 35 and Day 130
Number of Injection Site Reactions (ISRs) by the investigator on the scalp, before and immediately after each injection session (Day 0, Day 14, Day 28, Day 35, Day 42, Day 56, Day 70 and Day 130).
Time Frame: Day 0, Day 14, Day 28, Day 35, Day 42, Day 56, Day 70 and Day 130
Day 0, Day 14, Day 28, Day 35, Day 42, Day 56, Day 70 and Day 130
Number of adverse events (AEs) and concomitant treatments during the study.
Time Frame: Day 0 - Day 130
Day 0 - Day 130

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suisselle

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 27, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUU525AA2196 / 25-2196-U5
  • 2025-A02936-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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