An interventional study of Scalp booster injection (CBH) in Hair and Scalp Health, sponsored by Suisselle. Not yet recruiting at 2 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Suisselle · Not applicable, Interventional, and Treatment
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).
511 studies on the registry are indexed under Alopecia; 128 are open to participants now.
This study's planned enrollment of 55 is close to the median of 50 across 430 interventional studies indexed under Alopecia.
Browse Alopecia studies →Suisselle is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
In terms of population
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: Cellbooster Hair scalp injection
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
Change from baseline of hair diameter at Day 130 evaluated by Phototrichogram (PTG) analysis
Time frame: 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
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
Change from baseline of hair loss at Day 130 evaluated by Phototrichogram (PTG) analysis : anagen to telogen ratio (DA/DT)
Time frame: 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
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
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
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
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).
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
Time frame: 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
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).
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
Time frame: 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
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
Number of adverse events (AEs) and concomitant treatments during the study.
Time frame: Day 0 - Day 130
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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