Study on the Effectiveness of Clostridium Botulinum Neurotoxin Type A for Reducing Wrinkles in Adults

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for wrinkles and fine lines on the face. The treatment being tested is called Bocouture, which contains a substance known as Clostridium botulinum neurotoxin type A. This substance is commonly used in cosmetic procedures to reduce the appearance of wrinkles by temporarily relaxing the muscles.

The purpose of the study is to evaluate how satisfied participants are with the results of the treatment. Participants will receive either the actual treatment or a placebo, which is a substance with no active ingredients. The study will compare the satisfaction levels of those who receive the treatment with those who receive the placebo. The treatment will be administered in split doses, meaning it will be given in smaller amounts but more frequently than usual.

Participants will be involved in the study for a period of time, during which they will receive the treatment and attend follow-up visits. The main focus will be on the change in satisfaction from the beginning of the study to two months after the last treatment. The study will also monitor any adverse events, which are any unexpected or negative reactions to the treatment. The goal is to understand the overall satisfaction with the treatment and its safety.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on the inclusion criteria, such as age and health status.

You will be asked to provide informed consent, indicating your willingness to participate and comply with study requirements.

2 baseline assessment

A baseline assessment will be conducted to evaluate the current condition of your facial wrinkles and fine lines.

Your satisfaction with your appearance will be measured using the eVAS Satisfaction Scale, which ranges from 0 to 10.

3 treatment administration

You will receive a treatment with either Bocouture or a placebo. Bocouture is a solution for injection containing botulinum toxin.

The treatment involves split doses administered with double frequency, meaning you will receive injections more frequently than usual.

4 follow-up visits

You will attend several follow-up visits to monitor your response to the treatment.

These visits will help assess any changes in your satisfaction score and the appearance of your wrinkles.

5 final assessment

A final assessment will be conducted two months after the last treatment.

Your overall satisfaction will be measured again using the eVAS Satisfaction Scale to determine the effectiveness of the treatment.

6 reporting adverse events

Throughout the study, you are encouraged to report any adverse events or side effects you may experience.

This information is crucial for evaluating the safety of the treatment.

Who Can Join the Study?

Males or females, 18 to 65 years of age.
In general good health.
Have symmetrical wrinkles on both sides of the face, with a score of 2 or more in all treatment areas on the Merz Aesthetics Scales. (Symmetrical wrinkles mean that the wrinkles are similar on both sides of the face.)
A satisfaction score between 2 and 8 on the eVAS Satisfaction Scale, which ranges from 0 to 10. (This score measures how satisfied you are with your appearance.)
Able to participate and willing to give informed consent and follow the study rules. (Informed consent means you understand the study and agree to take part.)

Who Cannot Join the Study?

Participants must not have any serious skin conditions other than wrinkles or fine lines. This means no severe skin diseases or infections.
Participants should not have any allergies to the treatment ingredients. Allergies are when your body reacts badly to certain substances.
Participants must not be pregnant or breastfeeding. This is to ensure the safety of both the mother and the baby.
Participants should not have participated in another clinical trial in the last 30 days. This is to avoid any interference with the results of this study.
Participants must not have any medical conditions that the study doctors think could interfere with the study. This means any health issues that might affect the results or the participant’s safety.
Participants should not be using any medications that could interfere with the study. This means any drugs that might affect the treatment or the results.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Fujun cfhnkk	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	21.12.2020

Trial locations

Investigated drugs:

Clostridium Botulinum Neurotoxin Type A (150Kd), Free Of Complexing Proteins

Botulinum Toxin is a medication used in this clinical trial. It is a substance that can help relax muscles by blocking nerve signals. In this study, it is being used to see how effective it is when given in smaller amounts but more frequently. The goal is to find out if this method makes people more satisfied with their treatment results. Botulinum toxin is often used to reduce wrinkles or treat muscle-related conditions, and this trial is exploring a new way to use it to improve patient satisfaction.

Wrinkles – Wrinkles are lines or creases that form on the skin, often as a result of aging. They occur when the skin loses its elasticity and becomes thinner over time. Factors such as sun exposure, smoking, and repeated facial expressions can accelerate their development. Wrinkles typically start as fine lines and deepen as the skin continues to age. They are most commonly found on areas exposed to the sun, such as the face, neck, and hands. As the skin ages, it produces less collagen and elastin, which are proteins that help maintain its firmness and elasticity, leading to the formation of wrinkles.

Trial ID:

2025-520915-14-00

Protocol code:

14031972

Trial Phase:

Therapeutic use (Phase IV)

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Study on the Effectiveness of Clostridium Botulinum Neurotoxin Type A for Reducing Wrinkles in Adults

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?