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Topical Gel

Patients with Granuloma Annulare for Granuloma Annulare

Phase 1
Recruiting
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

Study Summary

This trial looks at how safe, tolerable, and effective a gel is for treating a skin disorder called Granuloma Annulare.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
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
+4 more

Side effects data

From 2020 Phase 4 trial • 4372 Patients • NCT02092467
22%
Upper respiratory tract infection
15%
Bronchitis
13%
Rheumatoid arthritis
13%
Urinary tract infection
12%
Nasopharyngitis
12%
Fall
12%
Herpes zoster
9%
Hypertension
8%
Arthralgia
7%
Diarrhoea
7%
Lymphopenia
7%
Sinusitis
7%
Back pain
6%
Influenza
6%
Osteoarthritis
6%
Latent tuberculosis
6%
Pharyngitis
5%
Nausea
5%
Anaemia
5%
Alanine aminotransferase increased
5%
Cough
4%
Gastroenteritis
3%
Pneumonia
3%
Headache
1%
Coronary artery disease
1%
Femur fracture
1%
Cellulitis
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tofacitinib 5 mg BID
Tofacitinib 10 mg BID
TNFi

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)

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

Frequently Asked Questions

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

What objectives are being sought with this research?

"According to the pharmaceutical company TWi Biotechnology, Inc., this trial's primary assessment criterion is a Change in skin irritation using Dermal Rating Scale (DRS). Secondary endpoints such as Apparent terminal half-life (T1/2), Time to maximum observed plasma drug concentration (Tmax), and Area under the plasma concentration-time curve from time 0 to extrapolated infinity will also be examined over a 6 week period. Blood samples shall be collected during visits 2 through 5."

Answered by AI

How many volunteers are enrolled in this experimental research?

"Indeed, the information published on clinicaltrials.gov indicates that this trial is seeking participants at present. It was initially posted on November 27th 2022 and most recently updated on November 2nd 2022. This study requires 15 patients to be recruited from a single location."

Answered by AI

Has the FDA certified a treatment for Granuloma Annulare?

"The safety of Granuloma Annulare is tentatively rated a 1 since this initial trial has only provided limited evidence for its effectiveness and the absence of adverse reactions."

Answered by AI

Does the current protocol of this research endeavor still permit new recruits?

"Affirmative. The clinical trial registry hosts documents that demonstrate the research is in search of 15 volunteers from a single site. This medical project was first published on November 27th 2022 and last updated on November 2nd 2022."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
What site did they apply to?
Yale Center for Clinical Investigation
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I have seen a dermatologist who tried injections and prescription creams which did not work. I haven't worn shorts or do much of anything that show my legs for six years. I know how depressing having GA is and want to join the fight to find treatment!
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Yale Center for Clinical Investigation: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Safety and Tolerability of AC-1101 Topical Gel in Patients With Granuloma Annulare
2022. "Study to Evaluate the Safety and Tolerability of AC-1101 Topical Gel in Patients With Granuloma Annulare". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05580042.
All > Xeljanz
~6 spots leftby Apr 2025
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