Serrano 143 - Madrid, Spain

Grupo Pedro Jaen

BOTOX

AbbVie

condition

allSponsorName

gender

Male

Female

overallStatus

Recruiting

Not yet recruiting

Active, not recruiting

Enrolling by invitation

Completed

Terminated

Withdrawn

Suspended

Unknown

type

Interventional

Observational

Expanded Access

phase

Early Phase 1

Phase 1

Phase 2

Phase 3

Phase 4

Not Applicable

funderTypes

Industry

Other U.S. Federal agency

All others

ageGroup

Child (birth-17)

Adult (18-64)

Older Adult (65+)

Collagen, elastin, and glycosaminoglycans, (eg, hyaluronic acid) are predominant component of the skin and they are key contributor to its characteristics such as strength, elasticity, and plumpness. Chronic reduction in any one of these components as well as a loss of muscle and fat mass contribute to the facial volume loss that characterizes the aging face. HAC 22L is a dermal filler administered via subcutaneous/supraperiosteal injection for volumizing effect. The purpose of the study is to assess adverse events and effectiveness of HAC 22L in adults with facial volume deficit.

HAC 22L is a novel injectable device being developed to improve mid-face volume. Participants are placed in 1 of 2 groups, called treatment arms. There is a 1 in 3 chance that participants will be assigned to the control group. Around 75 adult participants seeking improvement of mid-face volume will be enrolled in the study at approximately 20 sites worldwide.

Participants in the treatment group will receive HAC 22L injection at Day 1. Participants will have the opportunity to receive optional touch-up and will be followed for up to 24 months. An optional repeat treatment will be offered after the follow-up period. Participants in the control group will followed for 6 months (no treatment period). At completion of the control period, participants may exit or opt to receive the study treatment (inclusive of optional touch-up). Participants will then be followed for 6 months. No repeat treatment is offered to the control group.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by different methods such as medical assessments, questionnaires and instrument's measures.

A Study to Assess Adverse Events and Effectiveness of HAC 22L Injection for Mid-Face Volume in Adult Participants

The masseter muscle is one of the muscles in the lower face used for chewing. Prominence of the masseter muscle can appear as a widened and square lower face shape, which is an aesthetic concern for individuals who prefer a narrower and more ovoid lower face shape. Treatments are available for masseter muscle prominice (MMP), but researchers are looking for new non-surgical treatments. This study will assess adverse events and effectiveness of BOTOX in adult participants with MMP.

BOTOX is being investigated for the treatment of MMP. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is 1 in 4 chance that participants will be assigned to placebo. Around 248 adult participants with MMP will be enrolled in the study at approximately 30 sites in Europe.

Participants will receive either BOTOX or Placebo administered as 6 intramuscular injections to the masseter on Day 1. Participants who are eligible for retreatment will be given BOTOX on Day 180 and will be followed for up to 6 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

A Study to Assess the Effectiveness of BOTOX (Botulinum Toxin Type A) Injections for the Change of Masseter Muscle Prominence in Adult Participants

Grupo Pedro Jaen | Serrano 143 - Madrid, Spain

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Active trials

A Study to Assess Adverse Events and Effectiveness of HAC 22L Injection for Mid-Face Volume in Adult Participants

A Study to Assess the Effectiveness of BOTOX (Botulinum Toxin Type A) Injections for the Change of Masseter Muscle Prominence in Adult Participants

Trial sponsors