CGB-500 Ointment for Eczema

Recruiting at 15 trial locations

Overseen By Nitin Joshi, Ph.D.

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: CAGE Bio Inc.

Must not be taking: JAK inhibitors, CYP3A4 inhibitors

Disqualifiers: Pregnancy, Immunocompromised, Skin infections, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if CGB-500 works to treat atopic dermatitis in participants ages 12 and older. The goal is also to learn about the safety of CGB-500. The main questions it aims to answer are: Does CGB-500 improve atopic dermatitis by decreasing the area affected and the severity of the lesions? What medical problems do participants have when taking CGB500? Researchers will compare CGB-500 to a placebo (a look-alike substance that contains no drug) to see if CGB-500 works to treat atopic dermatitis. Participants will: Take CGB-500 or a placebo every day for 8 weeks. Visit the clinic once every 2 weeks for the first month and at the end of 8 weeks. Keep a diary of when they use the product and complete a form about their symptoms including itching.

Will I have to stop taking my current medications?

The trial requires participants to stop certain medications before starting. You must stop using moderate to strong CYP3A4 and CYP3A5 inhibitors 4 weeks before, topical JAK inhibitors 2 weeks before, and systemic JAK inhibitors 4 weeks before. Other specific medications and treatments also have required stop times before the trial begins.

What data supports the effectiveness of the drug CGB-500 ointment for eczema?

The research on clocortolone pivalate, a topical steroid, showed significant effectiveness in treating eczema, suggesting that similar topical treatments like CGB-500 might also be effective. Additionally, Sicorten, another topical treatment, showed good results in treating various forms of dermatitis, which is related to eczema. ^{1 2 3 4 5}

How is the drug CGB-500 ointment different from other eczema treatments?

CGB-500 ointment, containing sodium cromoglycate (SCG), is unique because it offers a non-steroidal option for treating eczema, potentially reducing inflammation and itching without the side effects associated with topical steroids. It may be particularly useful for mild to moderate eczema, although it might have a slower onset of action compared to other treatments. ^{6 7 8 9 10}

Eligibility Criteria

This trial is for individuals aged 12 and older with atopic dermatitis, including conditions like perianal dermatitis and eczema. Participants will use the treatment daily for 8 weeks and visit the clinic regularly. The eligibility criteria are not fully listed here.

Inclusion Criteria

Have an IGA (Investigator's Global Assessment) score of 2, 3, or 4 at Screening and Baseline

In general, good health as determined by medical history and physical examination at the time of screening (investigator discretion)

My itchiness level is 4 or higher on a scale of 0 to 10.

Exclusion Criteria

Medical or psychiatric conditions, or a personal situation, that may increase the risk associated with trial participation or may interfere with interpretation of trial results or participant compliance and, in the opinion of the PI, makes the participant inappropriate for trial entry

Immunocompromised individuals as adjudicated by the principal investigator (PI) based on review of medical history

Has clinically significant safety labs (hematology, chemistry, and urinalysis) at the Screening visit that, in the opinion of the investigator, would preclude participation in the study or affect proper assessment of the study endpoints

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive CGB-500 or placebo daily for 8 weeks, with clinic visits every 2 weeks for the first month and at the end of 8 weeks

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• CGB-500 (Topical Ointment)

Trial Overview The study tests CGB-500 ointment containing either 0.5% or 1% tofacitinib against a placebo to see if it improves skin affected by atopic dermatitis. It measures the change in area and severity of lesions over an eight-week period.

Participant Groups

Group I: CGB 500 ointment with 1% tofacitinib Experimental Treatment 1 Intervention

Group II: CGB 500 ointment with 0.5% tofacitinib Experimental Treatment 1 Intervention

Group III: vehicle ointment Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

CAGE Bio Inc.

Lead Sponsor

Trials

8

Recruited

430+

Findings from Research

In an open trial with 247 eczema patients, Sicorten topicals showed excellent results, with 90% to 100% effectiveness across different types of dermatitis, including atopic and contact dermatitis.

A double-blind trial with 108 patients indicated that Sicorten's effectiveness was comparable to Betnelan, suggesting that Sicorten is a safe and effective treatment option for various forms of dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sicorten: a synthetic corticosteroid for topical treatment of common dermatoses. Majerus, JP., Reiffers-Mettelock, J.[2013]

Narrowband ultraviolet B (NB-UVB) treatment resulted in a 61% reduction in eczema severity (measured by the SASSAD score) in 29 children, compared to a 6% increase in severity in a control group of 26 children who did not receive treatment.

The benefits of NB-UVB treatment not only improved objective eczema scores but also significantly enhanced quality of life, with effects lasting for at least 6 months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Narrowband ultraviolet B phototherapy in children with moderate-to-severe eczema: a comparative cohort study. Darné, S., Leech, SN., Taylor, AE.[2022]

There is currently limited evidence for effective treatments for chronic nodular prurigo (CNPG), as the systematic review found only three randomized controlled trials and six case studies with more than 15 patients, making it difficult to draw strong conclusions.

Ongoing and upcoming randomized controlled trials on new therapies may provide better treatment options for CNPG patients in the future, as existing therapies have shown heterogeneous results and lack targeted approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-Atopic Chronic Nodular Prurigo (Prurigo Nodularis Hyde): A Systematic Review of Best-Evidenced Treatment Options. Frølunde, AS., Wiis, MAK., Ben Abdallah, H., et al.[2022]

In a study involving 100 patients with eczema/atopic dermatitis, clocortolone pivalate 0.1% cream was found to be significantly more effective than a placebo in all measured outcomes, both objective and subjective.

The treatment was well-tolerated with no adverse reactions reported, indicating a high level of safety and excellent patient acceptance for both the active and placebo creams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clocortolone pivalate: a paired comparison clinical trial of a new topical steroid in eczema/atopic dermatitis. Rosenthal, AL.[2019]

In a phase 3 trial involving 211 patients with moderate-to-severe atopic dermatitis, lebrikizumab (LEB) combined with topical corticosteroids (TCS) significantly improved skin condition, with 41.2% of patients achieving a clear or almost clear skin score compared to 22.1% in the placebo group.

The safety profile of LEB was consistent with previous studies, with most adverse events being mild or moderate, and serious adverse events were similarly low in both the LEB and placebo groups, indicating that LEB is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adolescents and Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial (ADhere). Simpson, EL., Gooderham, M., Wollenberg, A., et al.[2023]

CTGO contains 29 identified compounds and has been shown to significantly improve skin conditions in eczema-affected rats by modulating key inflammatory markers and pathways.

The treatment appears to work primarily through the TLR4/NF-κB signaling pathway, suggesting a specific mechanism of action that could guide future research and development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated strategy of network analysis prediction and experimental validation to elucidate the possible mechanism of compound Turkish gall ointment in treating eczema. Ma, X., Hao, M., Zhang, MH., et al.[2022]

In a 12-week study involving 208 children with atopic dermatitis, a 4% sodium cromoglicate (SCG) emulsion significantly reduced the SCORAD score by 28% compared to a 19% reduction in the vehicle group, indicating its efficacy in treating the condition.

The SCG treatment also led to a significant reduction in the use of topical steroids, with 35% less usage in the SCG group, and was well-tolerated, with only 12.5% of subjects reporting discomfort at the application site.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised, controlled trial of a 4% cutaneous emulsion of sodium cromoglicate in treatment of atopic dermatitis in children. Berth-Jones, J., Pollock, I., Hearn, RM., et al.[2018]

In a trial with 42 children suffering from chronic atopic eczema, those treated with a 10% sodium cromoglycate ointment showed significant improvements in skin inflammation and symptoms compared to a placebo, with only 4 withdrawals due to ineffectiveness versus 16 in the placebo group.

No side effects were reported, suggesting that sodium cromoglycate ointment could be a safe alternative to topical steroids for treating atopic eczema in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of atopic eczema in children: clinical trial of 10% sodium cromoglycate ointment. Haider, SA.[2019]

A study involving 46 patients with chronic atopic eczema found that a topical cream containing 4% sodium cromoglycate (SCG) significantly improved symptoms after 9 weeks compared to a placebo, particularly in mild to moderate cases.

Despite the improvement, SCG showed limited effectiveness in severe eczema, possibly due to its delayed onset of action and low absorption, with bioavailability ranging from 0.01% to 2.75%, suggesting it may be more suitable for managing mild or moderate eczema over the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical sodium cromoglycate in the management of atopic eczema--a controlled trial. Ariyanayagam, M., Barlow, TJ., Graham, P., et al.[2019]

Wenguanmu ointment, a traditional Mongolian medicine, effectively treats eczema in mice by reducing inflammation, pain, and itching, as evidenced by decreased levels of pro-inflammatory cytokines and immunoglobulin E.

The ointment's therapeutic effects are linked to the inhibition of the CKLF-1/NF-κB signaling pathway, suggesting a specific mechanism of action that contributes to its efficacy in alleviating eczema symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mongolian medicine Wenguanmu ointment treats eczema by inhibiting the CKLF-1/NF-κB pathway. Zhu, L., Li, XJ., Gu, C., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Sicorten: a synthetic corticosteroid for topical treatment of common dermatoses. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Narrowband ultraviolet B phototherapy in children with moderate-to-severe eczema: a comparative cohort study. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Non-Atopic Chronic Nodular Prurigo (Prurigo Nodularis Hyde): A Systematic Review of Best-Evidenced Treatment Options. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Clocortolone pivalate: a paired comparison clinical trial of a new topical steroid in eczema/atopic dermatitis. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adolescents and Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial (ADhere). [2023]

6. England pubmed.ncbi.nlm.nih.gov

Integrated strategy of network analysis prediction and experimental validation to elucidate the possible mechanism of compound Turkish gall ointment in treating eczema. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A randomised, controlled trial of a 4% cutaneous emulsion of sodium cromoglicate in treatment of atopic dermatitis in children. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Treatment of atopic eczema in children: clinical trial of 10% sodium cromoglycate ointment. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Topical sodium cromoglycate in the management of atopic eczema--a controlled trial. [2019]

10. Ireland pubmed.ncbi.nlm.nih.gov

Mongolian medicine Wenguanmu ointment treats eczema by inhibiting the CKLF-1/NF-κB pathway. [2023]