← Back to Search

Virus Therapy

Topical KB105 for Ichthyosis

Phase 2

Waitlist Available

Research Sponsored by Krystal Biotech, Inc.

Eligibility Criteria Checklist

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

Must have

A genetically confirmed diagnosis of TGM1-deficient ARCI

Two target areas located on similar anatomical regions with the same scaling severity by IGA and scaling severity ≥3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 11 weeks

Awards & highlights

Study Summary

This trial tests a drug to see if it's safe and effective for children and adults with a skin disorder called ARCI.

Who is the study for?

This trial is for children and adults with a clinical diagnosis of lamellar ichthyosis, specifically TGM1-deficient ARCI. Participants must be in good health, at least 6 months old, and on a stable regimen if taking systemic retinoids or agree to a washout period. They cannot join if they have other skin conditions that could affect the study or are pregnant/nursing.Check my eligibility

What is being tested?

The trial tests KB105's safety and effectiveness against placebo in treating ARCI. It's an intrasubject randomized study where each participant receives both the treatment and placebo on different parts of their body without knowing which is which.See study design

What are the potential side effects?

While specific side effects aren't listed here, participants will be closely monitored for any adverse reactions to KB105 compared to the placebo during the trial.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have a genetic diagnosis of TGM1-deficient ARCI.

Select...

I have two skin areas with severe scaling of the same intensity.

Select...

I have been diagnosed with lamellar ichthyosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 11 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 11 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 11 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Composite Investigator's Global Assessment (IGA) Responder (Comparison of proportion of responder KB105 target areas to responder placebo target areas)

Secondary outcome measures

Composite regional Visual Index of Ichthyosis Severity (VIIS) responder (Comparison of proportion of responder KB105 target areas to responder placebo target areas)

Investigator's Global Assessment (IGA) 1 point responder

Investigator's Global Assessment (IGA) 2 point responder

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: KB105Experimental Treatment1 Intervention

Weekly topical application

Group II: PlaceboPlacebo Group1 Intervention

Weekly topical application

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Krystal Biotech, Inc.Lead Sponsor

12 Previous Clinical Trials

415 Total Patients Enrolled

1 Trials studying Ichthyosis

6 Patients Enrolled for Ichthyosis

Media Library

KB105 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05735158 — Phase 2

Ichthyosis Research Study Groups: KB105, Placebo

Ichthyosis Clinical Trial 2023: KB105 Highlights & Side Effects. Trial Name: NCT05735158 — Phase 2

KB105 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05735158 — Phase 2

Frequently Asked Questions

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

What safety measures have been taken to ensure the efficacy of KB105 in humans?

"Despite being a Phase 2 trial, meaning there is no efficacy data to support it yet, KB105 has been assessed as having an adequate safety profile and was assigned a score of 2."

Answered by AI

Are there any available slots left in this research program?

"According to the clinicaltrials.gov, this medical study is no longer actively seeking participants; the trial was first posted on March 1st 2023 and its last update took place on February 20th of the same year. Despite not recruiting anymore, 8 other trials remain active in their search for qualified individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Topical KB105 for the Treatment of TGM1-deficient Autosomal Recessive Congenital Ichthyosis (ARCI)

2023. "Topical KB105 for the Treatment of TGM1-deficient Autosomal Recessive Congenital Ichthyosis (ARCI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05735158.

All > Ichthyosis