All > Pflugerville Tx > Atopic Dermatitis

Study Drug Treated, BMX-010 0.1% for Atopic Dermatitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Austin Institute for Clinical Research, Pflugerville, TXAtopic DermatitisBMX-010 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial tests a product for AD: Subjects get 2 doses/day for 28 days, weekly visits to check progress, followed by a final visit 2 weeks later. Clinical assessors will be blind.

Eligible Conditions
  • Atopic Dermatitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 9 Secondary · Reporting Duration: 28 days

1 day
Change from baseline in Modified Pruritus Numerical Rating Scale (Current Itch Intensity; 30 minutes and 4 hours post-dose) on Day 1.
21 days
Change from baseline in Eczema Area and Severity Index at weeks 1, 2, and 3.
28 days
Change and percent change from baseline of subject-reported Patient-Oriented Eczema Measure (POEM) scores to Week 4.
Change from Baseline in Eczema Area and Severity Index at Week 4
Change from baseline in Body Surface Area x validated Investigator Global Assessment of Atopic Dermatitis scoreat Weeks 1, 2, 3, and 4
Change from baseline in answers on the subject reported PRO questions regarding itching at Weeks 1, 2, 3 and 4
Change from baseline in body surface area at Weeks 1, 2, 3, and 4.
Change from baseline in the Pruritus Numerical Rating Scale (NRS) at Weeks 1, 2, 3, and 4.
Change from baseline in validated Investigator Global Assessment of Atopic Dermatitis at Weeks 1, 2, 3, and 4.
Incidence of treatment emergent adverse events and changes from baseline in vital signs and clinical laboratory parameters
Proportion of subjects who achieve Eczema Area and Severity Index-50 and Eczema Area and Severity Index -75 at Weeks 1, 2, 3 and 4.
Proportion of subjects who achieve a validated Investigator Global Assessment of Atopic Dermatitis score of Almost clear (1) and/or Clear (0) with a 2-point reduction at Weeks 1, 2, 3, and 4.
8 days
Measurement of plasma concentrations of BMX-010 in participants receiving active treatment

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

2
ASLAN004
1
UCB1381
2
ASLAN004

Trial Design

3 Treatment Groups

Study Drug Treated, BMX-010 0.1%
1 of 3
Study Drug Treated, BMX-010 0.5%
1 of 3
Placebo Treated
1 of 3

Active Control

Non-Treatment Group

224 Total Participants · 3 Treatment Groups

Primary Treatment: Study Drug Treated, BMX-010 0.1% · Has Placebo Group · Phase 2

Placebo Treated
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Study Drug Treated, BMX-010 0.1%
Drug
ActiveComparator Group · 1 Intervention: BMX-010 · Intervention Types: Drug
Study Drug Treated, BMX-010 0.5%
Drug
ActiveComparator Group · 1 Intervention: BMX-010 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 28 days

Who is running the clinical trial?

Innovaderm Research Inc.OTHER
41 Previous Clinical Trials
2,447 Total Patients Enrolled
BioMimetix JV, LLCLead Sponsor
9 Previous Clinical Trials
601 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 12 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a potential candidate for a cream or ointment used to treat atopic dermatitis.
You must be willing to regularly use a moisturizing cream of your choice during the study.
References

Frequently Asked Questions

What objectives is the trial attempting to fulfill?

"This 28-day trial seeks to analyse the prevalence of treatment related adverse events, alterations in vital signs and laboratory parameters. Secondary objectives include determining the proportion of subjects achieving Eczema Area and Severity Index (EASI) 50% or 75% improvement at weeks 1, 2, 3 & 4 when using BMX-010 0.5 %/0.1%, changes from baseline EASI scores at weeks 1,2 &3; as well as Body Surface Area x validated Investigator Global Assessment of Atopic Dermatitis score modification at week intervals up until Week 4 for those receiving BMX-010 0.5 %" - Anonymous Online Contributor

Unverified Answer

Has the FDA sanctioned BMX-010 0.1% for medical use?

"The safety of BMX-010 0.1%, as evaluated by Power's team, was ranked 2 due to the lack of clinical data and efficacy concerning this Phase 2 trial." - Anonymous Online Contributor

Unverified Answer

In which geographical regions can participants access this research trial?

"Lenus Research in Sweetwater, Utah, Jordan Valley Dermatology Center in South Jordan, Indiana, and Physicians Research Group in West Lafayette, Texas are three of the sites currently enlisting patients for this trial. Additionally, there are 5 other locations recruiting participants as well." - Anonymous Online Contributor

Unverified Answer

Are any fresh participants being sought for this trial?

"Herein, the trial is still on the lookout for participants. According to clinicaltrials.gov, it was first posted on November 8th 2022 and the most recent amendment occurred 6 days later." - Anonymous Online Contributor

Unverified Answer

What is the enrollment count for this exploration?

"Affirmative. According to the information provided on clinicaltrials.gov, this trial is currently seeking recruits with its initial posting date being 8th November 2022 and latest edit taking place 16th November of the same year. For successful completion, 224 participants need to be recruited from 5 medical sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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