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Study on the Safety and Effectiveness of IPN10200 and Botulinum Toxin Type A for Adults with Moderate to Severe Upper Facial Lines

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What is this study about?

This clinical trial is focused on studying the treatment of moderate to severe upper facial lines, which are common concerns for many adults. The study will evaluate a new treatment called IPN10200, which is a type of botulinum toxin used to improve the appearance of these facial lines. Participants in the study will receive either the IPN10200 treatment or a placebo, which is a substance with no active medication, to compare the effects.

The purpose of the study is to assess the safety and effectiveness of IPN10200 in reducing the appearance of facial lines. The study will involve a series of visits where participants will receive injections and have their facial lines assessed by both doctors and themselves. The study will last for several weeks, with the main assessment taking place on Day 29 after the treatment. Participants will be monitored for any side effects and changes in their facial lines throughout the study.

During the study, participants will be asked to attend regular check-ups to monitor their health and the effects of the treatment. These check-ups will include physical examinations and assessments of facial lines. The study aims to find the best dose of IPN10200 that is both safe and effective in improving the appearance of facial lines. The results will help determine if IPN10200 can be a useful treatment option for people with moderate to severe upper facial lines.

1 joining the study

Upon joining the study, participants are required to provide informed consent, confirming their understanding and agreement to comply with the study requirements.

Participants must be between 18 and 65 years old and have moderate to severe upper facial lines.

2 initial assessment

An initial assessment is conducted to evaluate the severity of facial lines using a photographic scale and self-assessment.

Participants must not be pregnant or breastfeeding and must use effective contraception if applicable.

3 treatment administration

Participants receive a single treatment of either IPN10200 or a placebo. The treatment is administered as an injection into the muscles of the face.

The dosage is determined based on the study’s dose escalation and dose-finding protocol.

4 follow-up assessments

Follow-up assessments are conducted to monitor the safety and effectiveness of the treatment. These include physical and facial examinations, vital signs checks, and ECGs.

Participants’ responses to the treatment are evaluated through both investigator assessments and self-assessments at maximum contraction of facial muscles.

5 post-treatment visits

Post-treatment visits occur at specified intervals to assess the duration and onset of the treatment response.

Participants’ satisfaction with their facial appearance is measured using a satisfaction scale.

6 final evaluation

A final evaluation is conducted to determine the overall safety and efficacy of the treatment.

The presence of antibodies against the treatment is checked at specific post-treatment visits.

Who Can Join the Study?

  • Participants must be between 18 and 65 years old at the time of signing the consent form.
  • Participants must be able to give signed consent, which means they understand and agree to the study’s requirements and restrictions.
  • Participants must have the time and ability to complete the study and follow the study instructions.
  • Participants must not live in an institution due to a court or administrative order.
  • Participants must not be employees of the sponsor or the clinical research unit involved in the study, nor should they be immediate family members of such employees. Immediate family includes a spouse, parent, child, or sibling, whether biological or adopted.
  • Participants must have moderate to severe lines on their face, specifically in the upper facial area, as assessed by a doctor using a special scale.
  • Participants must be dissatisfied or very dissatisfied with their facial lines at the start of the study.
  • Both men and women can participate, but only women will be involved in dose escalation. Men must agree to use effective contraception if their partner could become pregnant, during the study and for 12 weeks after the study treatment.
  • Women must not be pregnant or breastfeeding. They must either be unable to have children or use an acceptable method of contraception during the study. Women who can have children must have a negative pregnancy test before starting the study.

Who Cannot Join the Study?

  • Participants with any known allergies to the study medication or its ingredients cannot join.
  • Individuals who have had any other facial cosmetic procedures recently may not be eligible.
  • People with certain skin conditions that affect the face might be excluded.
  • Participants who are pregnant or breastfeeding cannot take part in the study.
  • Anyone with a history of certain medical conditions that could interfere with the study results may not be allowed to participate.
  • Individuals currently taking medications that could affect the study outcomes might be excluded.
  • Participants who have been part of another clinical trial recently may not be eligible.
  • People with a history of drug or alcohol abuse might be excluded from the study.
  • Individuals who cannot comply with the study requirements or follow-up visits may not be able to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Privatpraxis Dr. Hilton & Partner Duesseldorf Germany
Aimed S.A.S. Lyon France

Other Sites

Site Name City Country Status
Rosenpark Research GmbH Darmstadt Germany
Hamburg University Hamburg Germany
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR Blankenfelde-Mahlow Germany
Praxis Prof. Schenck Munich Germany
Ttpwapk Paris France
Mfzbxw Szxhgz Antibes France
Nhwczbcmza Gpbr Kassel Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
06.04.2021
Germany Germany
Recruiting
06.04.2021

Trial locations

Investigated drugs:

IPN10200 is a treatment being studied for its ability to improve the appearance of moderate to severe upper facial lines in adults. The trial is designed to evaluate how safe and effective this treatment is when used in different doses. Participants in the study receive a single treatment of IPN10200, and the effects are measured by both the investigator’s assessment and the participant’s own assessment of their facial lines. The goal is to see if IPN10200 can reduce the appearance of these lines when the face is at maximum contraction.

Upper Facial Lines – Upper facial lines refer to the wrinkles and creases that appear on the forehead, around the eyes, and between the eyebrows. These lines are often caused by repeated facial expressions such as frowning, squinting, or raising the eyebrows. Over time, the skin loses elasticity and collagen, making these lines more pronounced. They can vary in severity from mild to severe, depending on factors like age, genetics, and sun exposure. The progression of these lines can lead to a more aged appearance, often prompting individuals to seek cosmetic treatments.

Trial ID:
2024-512782-14-00
Protocol code:
D-FR-10200-002
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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