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Topical Gel

Study to Evaluate the Safety and Tolerability of AC-1101 Topical Gel in Patients with 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 Dec 2025
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