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New treatment option for Atopic Dermatitis
Official title Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis (TIME-2)
ClinicalTrials.gov ID: NCT06504160
What this study is testing
What is ShA9 Topical Gel?
ShA9 Topical Gel is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for atopic dermatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1b, randomized, placebo/vehicle-controlled, double-blinded, multi-center trial. It is designed to assess the safety and efficacy of S.
- Phase 1: an early, usually small safety study
- Time commitment: about 14 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older
You may be able to join if
- Each individual must meet all of the following criteria at Screening to be eligible for enrollment as a study participant:
- Participant and/or parent/legal guardian must be able to understand and provide informed consent and assent (if applicable).
- Male or female participant 6 years of age or older.
- Meet ADRN Standard Diagnostic Criteria for active AD. Each individual must meet all of the following criteria at Baseline to be eligible for...
- Have at least 7 cm2 of lesional skin within the upper extremities, lower extremities, and/or trunk. Lesions on the face, neck, hands, feet, and...
You likely can't join if
- Individuals who meet any of the following criteria at Screening or Baseline are not eligible for enrollment as study participants:
- Inability or unwillingness to give written informed consent or comply with study protocol.
- Has self-reported as pregnant or lactating during the Screening or Baseline Visit, or is pregnant as indicated by a positive pregnancy test result...
- Sensitivity to or difficulty tolerating Dove® fragrance-free bar soap, Cetaphil® lotion, alcohol-based cleaners, clobetasol and fluocinonide...
- Known recalcitrance to topical steroids, including class 1 steroids, within 6 months of the Screening Visit.
- History of serious life-threatening reaction to tape or adhesives.
See the full eligibility criteria
Who can join
- Each individual must meet all of the following criteria at Screening to be eligible for enrollment as a study participant:
- Participant and/or parent/legal guardian must be able to understand and provide informed consent and assent (if applicable).
- Male or female participant 6 years of age or older.
- Meet ADRN Standard Diagnostic Criteria for active AD. Each individual must meet all of the following criteria at Baseline to be eligible for enrollment as a study participant:
- Have at least 7 cm2 of lesional skin within the upper extremities, lower extremities, and/or trunk. Lesions on the face, neck, hands, feet, and intertriginous areas do not count toward the required area, as samples may...
- Have at least 3% body surface area of AD involvement as indicated by derived total area of involvement score during SCORAD assessment.
- Have an IGA score of two or greater.
- Each potential participant who can become pregnant must meet either of the following criteria prior to randomization to be eligible for enrollment as a study participant.
- Willing to remain abstinent from intercourse that may result in a pregnancy.
- Willing to use an FDA-approved method of contraception for the duration of study participation. Acceptable methods include the following:
- Permanent sterilization of partner
- Long-acting reversible contraceptives (e.g., intrauterine devices or systems, implantable rods, contraceptive injections) when used as directed for at least 7 days prior to Baseline.
- Short-acting hormonal contraceptives (e.g., oral contraceptive pills, patch, vaginal ring) when used as directed for at least 30 days prior to Baseline
- Barrier methods (e.g., condoms; diaphragm, sponge, or cervical cap with spermicide)
- Have obtained negative pregnancy test results during both the Screening and Baseline Visits.
What rules you out
- Individuals who meet any of the following criteria at Screening or Baseline are not eligible for enrollment as study participants:
- Inability or unwillingness to give written informed consent or comply with study protocol.
- Has self-reported as pregnant or lactating during the Screening or Baseline Visit, or is pregnant as indicated by a positive pregnancy test result obtained at the Screening or Baseline Visit.
- Sensitivity to or difficulty tolerating Dove® fragrance-free bar soap, Cetaphil® lotion, alcohol-based cleaners, clobetasol and fluocinonide ointments, triamcinolone ointment, hydrocortisone ointment, glycerol...
- Known recalcitrance to topical steroids, including class 1 steroids, within 6 months of the Screening Visit.
- History of serious life-threatening reaction to tape or adhesives.
- Known allergy to all antibiotics to which S. hominis A9 is sensitive. These include ampicillin-sulbactam, cefazolin, cefoxitin, clindamycin, daptomycin, doxycycline, levofloxacin, linezolid, minocycline, moxifloxacin...
- Has a major defect in the epidermal barrier such as open wounds or genodermatoses (e.g., Netherton's syndrome).
- Is immunocompromised (e.g., Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS), Wiskott-Aldrich Syndrome) or has an immune system disorder (e.g., autoimmune disease).
- Has current malignant disease (except non-melanoma skin cancer in an area not affected by treatment).
- Has a history of psychiatric disease or history of alcohol or drug abuse that, in the opinion of the study investigator, would interfere with the ability to comply with the study protocol.
- Ongoing participation in another investigational trial or use of investigational drugs within 8 weeks, or five half-lives (if known), whichever is longer, of the Screening Visit.
- Treatment with non-steroid systemic immunosuppressant within 6 months of the Screening Visit.
- Treatment with any biologic, including dupilumab, within 16 weeks of the Screening Visit.
- Treatment with oral or injectable therapy for AD (excluding oral steroids) within five half-lives (if known) or 16 weeks before the Screening Visit, whichever is longer.
- Treatment with oral retinoids (e.g., isotretinoin) within 60 days of the Screening Visit.
- Treatment with allergen immunotherapy within 30 days of Screening Visit.
- Has close contacts (e.g., spouse, children, or members in the same household) who have severe barrier defects or are immunocompromised.
- May, in the opinion of the investigator, have difficulty tolerating the medication washout requirements for topical AD treatments, prescription moisturizers, antibiotics, oral steroid therapies, and phototherapy ahead...
- Past or current medical conditions or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the...
- Have more than 30% body surface area of AD involvement, as indicated by the derived total area of involvement score during SCORAD assessment.
- Active bacterial, viral, or fungal skin infections, except for onychomycosis and tinea pedis.
- Any noticeable breaks or cracks in the skin on the target areas of investigational product application, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection. a. At the...
- Use of topical AD treatments - including steroids and calcineurin inhibitors - on the upper extremities (exclusive of the hands), lower extremities (exclusive of the feet), or trunk within seven days of the Baseline...
- Treatment with prescription moisturizers classified as medical device (e.g., Atopiclair®, MimyX®, Epiceram®, etc.) on the upper extremities (exclusive of the hands), lower extremities (exclusive of the feet), or trunk...
- Use of any systemic microbialª within fourteen days of the Baseline Visit, or use of any topical antimicrobial on the upper extremities (exclusive of the hands), lower extremities (exclusive of the feet), or trunk...
- Within the upper extremities (exclusive of the hands), lower extremities (exclusive of the feet), and trunk, use of topical products - prescription or over-the-counter, all formulations - not specified per protocol...
- Use of systemic corticosteroid therapies for any indication within 28 days of the Baseline Visit.
- Use of systemic corticosteroid therapies for treatment of an asthma exacerbation within 3 months of the Baseline Visit.
- Require a dose greater than 880 mcg/day of fluticasone propionate or equivalent inhaled corticosteroid to maintain asthma control, at the time of the Baseline Visit.
- Any phototherapy for skin disease (such as narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen + UVA [PUVA]) or regular use (more than 2 visits per week) of a tanning bed within 28...
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- Denver, Colorado, United States
- Chicago, Illinois, United States
- New York, New York, United States
- Rochester, New York, United States
- Cincinnati, Ohio, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 14 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; Denver, Colorado, United States; Chicago, Illinois, United States; New York, New York, United States; Rochester, New York, United States; Cincinnati, Ohio, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.