Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504160
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis TIME-2
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Efficacy of Topical Bacteriotherapy for Atopic Dermatitis Using Staphylococcus Hominis A9
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 2 randomized placebovehicle-controlled double-blinded multi-center trial It is designed to assess the safety and efficacy of S hominis A9 ShA9 topical application as a treatment for atopic dermatitis AD The trial will enroll adults and adolescents with atopic dermatitis who are culture positive for S aureus colonization The primary objective of this study is to assess the ability of ShA9 compared to placebo vehicle to prolong the period of atopic dermatitis control over 12 weeks after conclusion of an initial two-week period of co-treatment with topical corticosteroids TCS
Detailed Description:
Protocol ADRN-14 TIME-2 is a Phase 2 randomized placebovehicle-controlled double-blinded multi-center trial designed to assess the safety and efficacy of ShA9 topical application as a treatment for AD This study will aim to enroll up to 86 participants participants must be 12 years of age or older have AD and test culture positive for S aureus SA on their lesional skin
An individual participants involvement in this study will take approximately 20 weeks to complete including approximately 2 weeks of screening 14 weeks of treatment and 4 weeks of safety follow-up
An initial screening visit will be conducted to evaluate eligibility including by assessing skin swabs collected from each participant for S aureus positivity SA participants will then begin an approximately 14-day period of standardized skin care by using over-the-counter products eg Dove soap Cetaphil moisturizer which will be distributed from the study clinic This is done to establish an informative baseline and allow for washout of any prohibited medications
Participants who continue to meet eligibility criteria will then be randomized 11 to use either ShA9 gel or placebo vehicle gel for treatment of AD Following randomization for two weeks each participant will receive co-treatment using TCS together with their assigned study product active or placebo Participants will then continue using their assigned study product without TCS for 12 more weeks Participants will be seen in clinic approximately every 4 weeks during this time for sampledata collection and safety monitoring Participants may be seen in clinic for additional visits to address any skin exacerbations while enrolled
Participation concludes with a 4-week safety follow-up period during which use of ShA9 or placebo vehicle gel is halted Participants will return to using over-the-counter products that will be distributed from the study clinic as needed continuing to avoid prohibited medications and will be monitored for skin exacerbations or other adverse events
An individual participants involvement in this study will take approximately 20 weeks to complete including approximately 2 weeks of screening 14 weeks of treatment and 4 weeks of safety follow-up
An initial screening visit will be conducted to evaluate eligibility including by assessing skin swabs collected from each participant for S aureus positivity SA participants will then begin an approximately 14-day period of standardized skin care by using over-the-counter products eg Dove soap Cetaphil moisturizer which will be distributed from the study clinic This is done to establish an informative baseline and allow for washout of any prohibited medications
Participants who continue to meet eligibility criteria will then be randomized 11 to use either ShA9 gel or placebo vehicle gel for treatment of AD Following randomization for two weeks each participant will receive co-treatment using TCS together with their assigned study product active or placebo Participants will then continue using their assigned study product without TCS for 12 more weeks Participants will be seen in clinic approximately every 4 weeks during this time for sampledata collection and safety monitoring Participants may be seen in clinic for additional visits to address any skin exacerbations while enrolled
Participation concludes with a 4-week safety follow-up period during which use of ShA9 or placebo vehicle gel is halted Participants will return to using over-the-counter products that will be distributed from the study clinic as needed continuing to avoid prohibited medications and will be monitored for skin exacerbations or other adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None