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Virus Therapy

Gene Therapy for Skin Depressions

Phase 1

Recruiting

Research Sponsored by Krystal Biotech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cohort 1 - region of healthy buttock skin

Treatment group- Unilateral region of the cheek below the zygomatic arch, which was randomized to received placebo under Cohort 2, that per investigator assessment and consultation with the sponsor at Visit 1, is determined to be uneven as compared to the Target Area which received KB301

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trialtests a gene therapy that could help treat skin depressions, like acne scars.

Who is the study for?

This trial is for adults aged 18-75 with healthy skin or mild to moderate wrinkles and roughness. Participants must have specific areas of skin suitable for treatment, not be pregnant or nursing, agree to contraception if applicable, and have no recent cosmetic procedures or conditions that could affect results.Check my eligibility

What is being tested?

The study tests KB301, a gene therapy designed to improve superficial skin depressions by expressing collagen. It's compared against a placebo in different cohorts based on the severity and location of their skin issues.See study design

What are the potential side effects?

As this is an early-phase trial for KB301, potential side effects are being studied but may include local reactions at the injection site such as redness, swelling, pain or possible systemic responses due to new collagen expression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am in the group that involves healthy skin on my buttock.

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My cheek area treated with a placebo is uneven compared to the area treated with KB301.

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I have mild to moderate crow's feet wrinkles even when not moving my face.

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My doctor has identified suitable skin areas for treatment.

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I have two healthy areas on my buttocks, 6 cm apart.

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I have moderate to severe fine lines and rough skin on both sides of my cheeks.

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I am part of a study group observing the effects of a high dose treatment on my cheeks.

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I received a high dose of KB301 below my cheekbones.

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I am between 18 and 75 years old and in good health.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessment of the safety profile of KB301 by recording adverse events using MedDRA System Organ Class and Preferred Term and collection of other clinical study procedures.

Secondary outcome measures

Assessment of fine line improvement as compared to baseline, using the Fine Lines Scale (FLS).

Assessment of skin fold thickness improvement over baseline, using a Caliper.

Assessment of skin roughness as compared to baseline, using the Skin Roughness Scale (SRS).

+6 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: KB301Active Control1 Intervention

non-integrating HSV-1 vector expressing human type III collagen

Group II: PlaceboPlacebo Group1 Intervention

sterile isotonic saline

0 / 9Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Krystal Biotech, Inc.Lead Sponsor

12 Previous Clinical Trials

345 Total Patients Enrolled

Media Library

KB301 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04540900 — Phase 1

Rough Skin Research Study Groups: Placebo, KB301

Rough Skin Clinical Trial 2023: KB301 Highlights & Side Effects. Trial Name: NCT04540900 — Phase 1

KB301 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04540900 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

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"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin Depressions

2020. "A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin Depressions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04540900.

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