Clinical Studies

Adults (Ages 18 – 75) with Mild-to-Moderate Crow’s Feet or Decolletage (Chest) Wrinkles Needed for two Research Studies of KB301, an Injectable Gene Therapy

Study Basics

Krystal Biotech, Inc. in collaboration with Aesthetx, is conducting two research studies to evaluate the safety and effectiveness of an investigational gene therapy, KB301, for the improvement of mild-to-moderate crow’s feet in one study, and mild-to-moderate active (wrinkles formed when arms are crossed) decolletage (chest) wrinkles in the other study. Participants will be adults between the ages of 18 and 75 years old.

Study Purpose

KB301 is a gene-delivery technology designed to stimulate a patient’s own cells to produce an important structural protein that normally declines over time with aging and photodamage. In these studies, KB301 is being used to correct the underlying cause of crow’s feet and/or decolletage wrinkles by increasing the natural expression of collagen 3. KB301 has been administered to adult participants in prior studies. The intent of these studies is to further evaluate the safety of KB301 and the improvement of mild-to-moderate crow’s feet and/or decolletage wrinkles.

Could one of both of these studies be right for you?

  • Crow’s feet study is enrolling any gender between the ages of 18 – 75
  • The decolletage study is enrolling females between the ages of 18 – 75
  • Both studies require light-to-medium skin color
  • No medical aesthetics treatments in the crow’s feet or decolletage area in the last 6 months
  • Not pregnant or breastfeeding

What participants can expect

The studies involve traveling to Aesthetx for KB301 administration, which will occur once a week for 3 consecutive weeks. Following these administration visits, you will return to Aesthetx 3 additional times for follow-up; first, one month following the last administration visit and then 2 and 3 months following the last administration visit.

Each study procedure includes physical exam of the eye area and/or decolletage (chest) area, vital sign monitoring, questionnaires, and photography of the face or decolletage area using a specialized camera system. The treatment with KB301 to both crow’s feet and/or decolletage areas will be performed via injection with a very small needle by the study doctor, Dr. Amelia K. Hausauer, who is a board-certified dermatologist and highly experienced medical aesthetics physician.

More details about the study can be found at: https://clinicaltrials.gov/ct2/show/NCT04540900

KB301 is not FDA approved for the purposes of this study.

Compensation and reimbursements

Participants in each study will receive compensation based on the number of visits completed. Visits 1,2, and 3 will be compensated at $150 each. Visits 4, 5, and 6 will be compensated at $90 each. Follow-up calls will be compensated at $15 each. If you are interested in being a participant, please reach out to clinicaltrials@aesthetx.com.

 

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