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Gene Therapy for Skin Depressions
Study Summary
This trialtests a gene therapy that could help treat skin depressions, like acne scars.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- I have been treated with KB301 before.I am willing to follow the study's birth control requirements.I am in the group that involves healthy skin on my buttock.My cheek area treated with a placebo is uneven compared to the area treated with KB301.I have mild to moderate crow's feet wrinkles even when not moving my face.I've had surgery on the area being studied, which might affect the trial results.My doctor has identified suitable skin areas for treatment.I am not pregnant or nursing.I have two healthy areas on my buttocks, 6 cm apart.I haven't had laser or chemical peels on the target areas in the last 6 months.I have moderate to severe fine lines and rough skin on both sides of my cheeks.I am part of a study group observing the effects of a high dose treatment on my cheeks.I received a high dose of KB301 below my cheekbones.Your skin type is classified as I-IV according to the Fitzpatrick scale.I am between 18 and 75 years old and in good health.I do not have skin conditions near the target area that could affect the study.
- Group 1: Placebo
- Group 2: KB301
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this research program permit elderly participants?
"This clinical trial has a minimum age requirement of 18 and an upper limit of 75, in adherence with the stated inclusion criteria."
What has been determined about the safety of KB301 for human consumption?
"Our evaluation at Power has rated the safety of KB301 a 1 because it is only in Phase 1, meaning there is limited evidence affirming its safety and efficacy."
Are enrolment opportunities still available for this experiment?
"According to the clinicaltrials.gov registry, this trial is not currently searching for individuals at present. It was initially published on October 7th 2020 and most recently edited on December 12th 2022; however, 1167 other trials are actively seeking participants presently."
What is the main purpose of this research endeavor?
"This trial will last 12 months, during which the primary outcome - assessing KB301's safety profile by recording adverse events - and several secondary outcomes will be tracked. These include an evaluation of KB301's durability compared to baseline as well as measurements of skin roughness and fine line improvements using respective scales ranging from 0-4 (assessed by a blinded third party)."
Is it possible to become involved in this clinical investigation?
"This clinical trial is looking for 44 participants between the ages of 18 and 75 that have been diagnosed with depression. Additionally, they must meet these criteria: Treatment Group - region below zygomatic arch randomized to receive placebo during Cohort 2 which was determined by investigator assessment at Visit 1 to be asymmetrical compared to Target Area receiving KB301; Observational Group - two cheeks underneath zygomatic arch randomly assigned high dose 301 in Cohort 2 exhibiting durability of KB301 on one or more Target Areas; Male/Female subjects who are healthy as per judgement of investigator aged between 18 and 75 upon consent signing; Cohort 1- Healthy buttock"
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