NCT04548349|CompletedPhase 4ResultsFDA Drug
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Sponsor study identifier
interventional
25
1 country
1
Study Start
April 23, 2021
Actual (reported)Primary Completion
August 22, 2022
Actual (reported)Study Completion
August 22, 2022
Actual (reported)The study objective is to characterize the shift in the diversity and abundance of the skin microbial community at baseline and in response to Altreno monotherapy as compared to benzoyl peroxide (BPO) 2.5% leave-on gel monotherapy in acne patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 22, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 20, 2020
Actual (reported)September 14, 2020
Actual (reported)April 23, 2021
Actual (reported)August 22, 2022
Actual (reported)August 22, 2022
Actual (reported)February 6, 2024
Actual (reported)CLR-transformed Abundance of Any Significant Taxa
The primary outcome measures the relative abundance of Kingella after treatment with Altreno in acne patients vs without treatment in healthy subjects. The relative abundance was represented as centered log ratio (CLR) transformation. These values are all relative terms centered around 0, more negative means less abundant in comparison. More positive means more abundant in comparison.
Baseline, 90 days after treatment, and followed by 30 days of no treatment
During the entire study period, the subjects in the control group will not be allowed to use any antibacterial wash, other than approved OTC cleansers.
Beth Israel Deacones Medical Center
Boston, Massachusetts, 02115, United States
Chien AL, Tsai J, Leung S, Mongodin EF, Nelson AM, Kang S, Garza LA. Association of Systemic Antibiotic Treatment of Acne With Skin Microbiota Characteristics. JAMA Dermatol. 2019 Apr 1;155(4):425-434. doi: 10.1001/jamadermatol.2018.5221.
Kelhala HL, Aho VTE, Fyhrquist N, Pereira PAB, Kubin ME, Paulin L, Palatsi R, Auvinen P, Tasanen K, Lauerma A. Isotretinoin and lymecycline treatments modify the skin microbiota in acne. Exp Dermatol. 2018 Jan;27(1):30-36. doi: 10.1111/exd.13397. Epub 2017 Sep 14.
* BPO arm only have 1 participant, so we decided to drop this arm. * Small sample size, high drop out rate, and high failure rate of DNA extraction were the limitations of this study among others.
25 participants (actual enrollment reported by the registry).
First Submitted
July 20, 2020
First Posted
September 14, 2020
Study Start
April 23, 2021
Actual (reported)Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants
Contact the study team to confirm eligibility.
Primary Completion
August 22, 2022
Actual (reported)Study Completion
August 22, 2022
Actual (reported)Last Updated
February 6, 2024
Results First Posted
February 6, 2024
Record last verified: 2024-02
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Source: ClinicalTrials.gov.
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