← Back to Search

Topical Gel

Patients with Granuloma Annulare for Granuloma Annulare

Phase 1
Waitlist Available
Led By William Damsky, M.D., Ph.D.
Research Sponsored by TWi Biotechnology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 14, day 42:pre-dose; day 28: pre-dose, 2 through 24 hours post-dose
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a special skin-applied gel called AC-1101 on patients with Granuloma Annulare, a specific skin condition. The gel likely works by reducing inflammation or changing the immune response in the skin.

Eligible Conditions
  • Granuloma Annulare

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 14, day 42:pre-dose; day 28: pre-dose, 2 through 24 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 14, day 42:pre-dose; day 28: pre-dose, 2 through 24 hours post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in skin irritation using Dermal Rating Scale (DRS)
Incidence and proportion of subjects with treatment emergent adverse events (TEAEs), AEs and serious adverse events (SAEs).
Electrocardiogram
+4 more
Secondary study objectives
Apparent terminal half-life (T1/2) of AC-1101
Area under the plasma concentration-time curve from time 0 to extrapolated to infinity (AUC[0-infinity]) of AC-1101
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC[0-t]) of AC-1101
+3 more
Other study objectives
Change in Dermatology Life Quality Index (DLQI)
Change in GA-Investigator Global Assessment (GA-IGA) score for the treated GA lesions
Change in Granuloma Annulare Severity and Morphology Instrument (GASMI) activity score for the treated GA lesions
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with Granuloma AnnulareExperimental Treatment1 Intervention
4-week treatment and 2-week follow-up period (without treatment)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AC-1101
2022
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

TWi Biotechnology, Inc.Lead Sponsor
9 Previous Clinical Trials
677 Total Patients Enrolled
William Damsky, M.D., Ph.D.Principal InvestigatorYale Department of Dermatology

Media Library

AC-1101 (Topical Gel) Clinical Trial Eligibility Overview. Trial Name: NCT05580042 — Phase 1
Granuloma Annulare Research Study Groups: Patients with Granuloma Annulare
Granuloma Annulare Clinical Trial 2023: AC-1101 Highlights & Side Effects. Trial Name: NCT05580042 — Phase 1
AC-1101 (Topical Gel) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05580042 — Phase 1
Granuloma Annulare Patient Testimony for trial: Trial Name: NCT05580042 — Phase 1
~4 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top