Effectiveness and Safety of Cellbooster Hair in Healthy Subjects

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio

De intervención

Fase

No aplica

Rango de edad

18 años - No especificado

Sexo admitido

Todos los sexos

Voluntarios sanos

Aceptados

Participantes

55 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

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).

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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.

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación

No aplica

Enmascaramiento

Sin enmascaramiento

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Medidas secundarias

Centros de investigación (2)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

2 centros

Equipo y fechas

Patrocinador principal

Suisselle

Inicio del estudio

27 ene 2027 Estimado

Finalización primaria

31 oct 2027 Estimado

Finalización del estudio

31 oct 2027 Estimado

Primera publicación

10 nov 2026 Real

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio