Is NCT07027345 recruiting in Chicago, IL?

Yes, NCT07027345 is currently recruiting participants at its Chicago, IL location. This epidermolysis bullosa simplex clinical trial is actively enrolling qualified participants.

How do I join the epidermolysis bullosa simplex clinical trial in Chicago?

To join this clinical trial in Chicago, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Chicago clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Epidermolysis Bullosa Simplex Clinical Trial in Chicago, IL

About This Epidermolysis Bullosa Simplex Study in Chicago

This Phase II clinical study will assess the efficacy, safety and tolerability of topical TolaSure Gel in adults and pediatric patients (4 years of age and older) diagnosed with generalized intermediate to severe epidermolysis bullosa simplex (EBS). Each patient (40 to complete) will be enrolled in the study and will be randomized to receive either TolaSure Gel or a topical Placebo for daily application for 2-months. After 2-months, all patients will receive TolaSure Gel to daily apply for an ad

Sponsor: BioMendics, LLC

Who Can Participate

Inclusion Criteria

Patient is a male or female at least 2 years of age.

Patient has a documented diagnosis and confirmed clinical history of localized (previously known as Weber-Cockayne), intermediate (previously Kӧbner), or severe (previously EBS-Dowling Meara) autosomal dominant EBS and/or a genetic mutation in either the KRT14 or KRT5 gene consistent with localized, intermediate, or severe EBS. The Investigator will determine patient eligibility based on historical phenotypic presentation of EBS symptoms along with genetic/diagnosis documentation to determine EBS severity. (If localized, intermediate, or severe EBS is suspected but not diagnosed or genetically confirmed, confirmatory testing will be performed).

For localized EBS participants:

Patient must have at least moderate plantar disease activity, defined as ≥15% involvement of the plantar surface of at least one foot, as assessed by clinical examination or standardized imaging, with evidence of active disease (e.g., blisters, erosions, or crusting).

For treatment, the Target Lesional Area (TLA) will consist of daily treating the feet (tops and bottoms) which is approximately 7% body surface area (BSA). Localized EBS subjects will also have the option to treat their hands (tops and bottoms), which is approximately an additional 6% BSA. Palmoplantar evaluation is separate from the intermediate to severe TLA-treated regions per protocol.

For intermediate to severe EBS participants: Patient is actively flaring in one of the preferred target lesional areas (TLAs): 1) lower extremities (ideally below the knee and above the ankle or between the knee and top of the thigh) or 2) torso (excluding the groin and apocrine areas). The following skin conditions are required for treatment purposes:

A TLA is defined as a contiguous or non-contiguous region totaling up to \~15-20% body surface area (BSA).

A flare is defined as a minimum area of \~2-3% Body Surface Area (BSA) containing intact blisters (of varying size and number), and freshly ruptured blisters across 50% of the TLA (as assessed by the principal investigator (PI)). Skin erosions, keratoderma, fissures and/or erythema may also be present.

Patients will be permitted to treat their feet to assess plantar blister surface area but blistering on the feet is not a requirement for study inclusion and is evaluated separately per protocol.

For all patients (with localized, intermediate, and severe EBS), the TLA may not be infected (as assessed by PI) or have been treated with a topical antibiotic within 14 days.

If the patient is a woman of childbearing potential (WOCBP),

Has a negative urine pregnancy test.

Agrees to use an approved effective form of birth control with failure rates \<1% per year (e.g., implant, injectable, combined oral contraceptive, intrauterine contraceptive device, sexual abstinence, vasectomized partner) during participation in the study (and at least 3 months thereafter).

Is not nursing.

Patient's laboratory values (blood and urine) are within the range of normal or abnormal values are within normal levels for the disease and in the opinion of the PI the values are not clinically relevant for study participation.

Patient is in good, general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of the EBS lesions or which exposes the subject to an unacceptable risk by study participation.

Over the duration of the study, the patient agrees to not use any other topical therapies and/or impregnated dressings within the TLAs (e.g., medicated cleansers, CBD oil, MediHoney, Silvadine cream 1%, topicals containing antimicrobials, keratin, and/or collagen, lipido-colloid or polymeric membrane dressings, and/or hydrogels).

Patient and/or legally appointed and authorized representative must be able and willing to follow study procedures and instructions in order to maintain compliance throughout the study period.

The patient or legally appointed and authorized representative must have read, understood and signed an Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent or Assent Form.

Exclusion Criteria

Patient's use of prior or concomitant medication or medical treatments/procedures:

Any investigational drug or therapy within 30 days.

Systemic steroidal therapy within 30 days.

Topical steroidal therapy within 14 days (Note: inhaled and ophthalmic products containing steroids are allowed).

Systemic antibiotic therapy within 7 days.

Currently receiving chemotherapy or radiation.

Surgery within the previous 2 weeks (except for minor surgery, cosmetic or dental procedures as determined by the investigator).

Started to take chronic medications (NSAIDs, antihistamines, etc.) at least 30 days prior to starting study medication.

Patient's medical history includes:

Cancer that is currently undergoing treatment.

History of chronic and severe vitamin, mineral, or protein deficiency.

Current systemic infection.

Non-EBS skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn) that, in the opinion of the investigator, might put the patient at undue risk by study participation or interferes with the study medication application or the study assessments.

An illness (e.g., neurological, cardiovascular, respiratory, hepatic, renal, or metabolic disease), condition, or situation that in the opinion of the principal investigator is likely to interfere with the patient's participation in or completion of the study.

Factors present in the patient and/or his/her legal representative that could interfere with study compliance such as inability to attend scheduled study visits or to perform study protocol procedures.

Patient is a member of the investigational team or his/her immediate family.

Other unspecified reasons that, in the opinion of the Investigator, make the patient unsuitable for enrollment.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Chicago?

Yes, this clinical trial (NCT07027345) has an active research site in Chicago, IL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Epidermolysis Bullosa Simplex Treatment Options in Chicago, IL

If you're searching for epidermolysis bullosa simplex treatment options in Chicago, IL, this clinical trial (NCT07027345) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Chicago research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced epidermolysis bullosa simplex specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all epidermolysis bullosa simplex clinical trials near you to find additional studies recruiting in your area.

Epidermolysis Bullosa Simplex Clinical Trial in Chicago, IL

Expert Care in Chicago

IRB Approved

No-Cost Care

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