A Phase 4 interventional study of Dicloxacillin Oral Capsule and Elocon 0.1 % Topical Cream in Atopic Dermatitis, Atopic Dermatitis Eczema and Atopic Dermatitis Flare, sponsored by Jacob Pontoppidan Thyssen. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-12-21.
Sponsored by Jacob Pontoppidan Thyssen · Phase 4, Interventional, and Treatment
The goal of this clinical trial is to compare and evaluate in patients with atopic dermatitis. The main questions it aims to answer are:
Participants will meet for two different phases:
The investigators hypothesize:
Use of oral systemic antibiotic treatment with dicloxacillin (1000 mg x 3 times a day) will decrease the time to AD improvement as well as the amount of S. aureus and its toxins and alter the skin microbiome.
Specifically, the investigators aim to investigate the following research questions:
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's planned enrollment of 45 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Jacob Pontoppidan Thyssen is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
EXCLUSION CRITERIA:
20 of the participating patients are randomized to the active arm where systemic dicloxacillin and elocon creme (mometasone furoate 0.1%) is received.
Drug: Dicloxacillin Oral Capsule · Drug: Elocon 0.1 % Topical Cream
20 of the participating patients are randomized to the placebo arm where placebo and elocon creme (mometasone furoate 0.1%) is received.
Drug: Elocon 0.1 % Topical Cream
Randomized to either systemic dicloxacillin \& elocon or placebo \& elocon
Also known as: Elocon (Mometasone furoate 0.1%)
Both groups are treated with elocon for five days.
Also known as: Mometasone furoate 0.1%
Change in The Total Lesion Symptom Scale (TLSS) score improvement
The primary endpoint is to describe if addition of systemic dicloxacillin treatment (1000 mg x 3 times a day) to topical treatment with mometasone furoate 0.1% cream once daily increases the rapidity and depth of the treatment response measured as changes in The Total Lesion Symptom Scale (TLSS) score improvement. The score is a numerical scale from 0-15.
Time frame: Through study completion, an average of 1 year
Changes in the skin microbiome measured as community composition (beta-diversity) visualised as PCOA plots
Describe changes in the skin microbiome measured as community composition during i) treatment with systemic dicloxacillin treatment (1000 mg x 3 times a day) and mometasone furoate 0.1% cream once daily ii) treatment with mometasone furoate 0.1% cream once daily iii) cutaneous application of respectively SEB and S. aureus from the patient's self, compared to vehicle
Time frame: 1 year
Changes in the skin microbiome measured as alfa-diversity (Shannon diversity)
Describe changes in the skin microbiome measured as immune response during i) treatment with systemic dicloxacillin treatment (1000 mg x 3 times a day) and mometasone furoate 0.1% cream once daily ii) treatment with mometasone furoate 0.1% cream once daily iii) cutaneous application of respectively SEB and S. aureus from the patient's self, compared to vehicle
Time frame: 1 year
Changes in the skin microbiome measured as relative abundance (%) of baterial genera
During i) treatment with systemic dicloxacillin treatment (1000 mg x 3 times a day) and mometasone furoate 0.1% cream once daily ii) treatment with mometasone furoate 0.1% cream once daily iii) cutaneous application of respectively SEB and S. aureus from the patient's self, compared to vehicle
Time frame: 1 year
Changes in the amount of cytokines
Describe changes in the epidermal barrier disruption through changes in cytokines (to Il-1a, IL-4, IL-13, IL-1RA, CXCL-9, IL-22, IL-31, IL-8, IL-18, CCL-17, CCL-18, CCL-20, CCL-22, CXCL-10, VEGF-A) during i) treatment with systemic dicloxacillin treatment (1000 mg x 3 times a day) and mometasone furoate 0.1% cream once daily ii) treatment with mometasone furoate 0.1% cream once daily iii) cutaneous application of respectively SEB and S. aureus from the patient's self, compared to vehicle
Time frame: 1 year
Changes in itch with peak pruritus 24 hours
Changes in itch on a scale from 0-10 during i) treatment with systemic dicloxacillin treatment (1000 mg x 3 times a day) and mometasone furoate 0.1% cream once daily ii) treatment with mometasone furoate 0.1% cream once daily iii) cutaneous application of respectively SEB and S. aureus from the patient's self, compared to vehicle.
Time frame: Through study completion, an average of 1 year
The effects of treatment on markers of bone resorption and formation with C-terminal telopeptide of type I collagen (CTX)
The investigators aim to investigate the effects of treatment on markers of bone resorption and formation including C-terminal telopeptide of type I collagen (CTX) because TCS such as mometasone furoate may increase bone resorption as seen in a large epidemiologic study.
Time frame: 1 year
The effects of treatment on markers of bone resorption and formation with N-terminal propeptide of type 1 procollagen (P1NP)
The investigators aim to investigate the effects of treatment on markers of bone resorption and formation including N-terminal propeptide of type 1 procollagen (P1NP) because TCS such as mometasone furoate may increase bone resorption as seen in a large epidemiologic study.
Time frame: 1 year
The effects of treatment on markers of bone resorption and formation with parathyroid hormone (PTH)
The investigators aim to investigate the effects of treatment on markers of bone resorption and formation including parathyroid hormone (PTH), because TCS such as mometasone furoate may increase bone resorption as seen in a large epidemiologic study.
Time frame: 1 year
Changes in sleep-Numeric rating scale
Changes in sleep on a numerical rating scale from 0-10 during: i) treatment with systemic dicloxacillin treatment (1000 mg x 3 times a day) and mometasone furoate 0.1% cream once daily ii) treatment with mometasone furoate 0.1% cream once daily iii) cutaneous application of respectively SEB and S. aureus from the patient's self, compared to vehicle.
Time frame: Through study completion, an average of 1 year
Changes in pain-Numeric rating scale
Changes in pain on a numerical rating scale from 0-10 during: i) treatment with systemic dicloxacillin treatment (1000 mg x 3 times a day) and mometasone furoate 0.1% cream once daily ii) treatment with mometasone furoate 0.1% cream once daily iii) cutaneous application of respectively SEB and S. aureus from the patient's self, compared to vehicle.
Time frame: Through study completion, an average of 1 year
The Eczema Area and Severity Index (EASI)
Changes in EASI score during: i) treatment with systemic dicloxacillin treatment (1000 mg x 3 times a day) and mometasone furoate 0.1% cream once daily ii) treatment with mometasone furoate 0.1% cream once daily iii) cutaneous application of respectively SEB and S. aureus from the patient's self, compared to vehicle.
Time frame: Through study completion, an average of 1 year
Plan to share: No — Due to Danish data protection law sharing IPD is not planned. Data outcomes should be anonymized without any recognizable information.
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Jacob Pontoppidan Thyssen