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The role and application of skin microbiota and its metabolites in atopic dermatitis (revision 1)

The role and application of skin microbiota and its metabolites in atopic dermatitis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080943
Enrollment
Unknown
Registered
2024-02-19
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atopic dermatitis

Interventions

positive control group of topical probiotics for AD patients:Apply live C. acnes preparation to the skin lesions on one side of the face and forearm, and apply 0.1% tacrolimus cream to the correspondi
negative control group of topical probiotics for AD patients:Apply the live preparation of C. acnes to the skin lesions on one side of the face and forearm, and apply the control excipient to the corr
Healthy people control group of topical probiotics:Apply the live preparation of C. acnes to one side of the face and forearm, and apply the control vehicle to the corresponding part on the other side
Acne patients control group of topical probiotics:Apply the live preparation of C. acnes to the skin lesions on one side of the face, and apply the control excipient to the corresponding skin lesions

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 60 Years

Inclusion criteria

Inclusion criteria: Atopic dermatitis patient: ? The Dermatology Clinic of Huashan Hospital Affiliated with Fudan University meets the clinical diagnostic criteria for atopic dermatitis (Hanifin-Rajka diagnostic criteria). ? SCORAD score >0 points, <50 points. ? The age of subjects is 12-60 years old, and the male-to-female ratio is 1:1. ? No systemic use of anti-inflammatory drugs, such as glucocorticoids, cyclosporine, methotrexate, azathioprine, mycophenolate mofetil, etc. within 1 month; no systemic use of antibiotics and antifungal drugs within 1 month; 2 weeks No topical anti-inflammatory drugs such as corticosteroids and calcineurin were used within 2 weeks; no topical antibiotics or antifungal drugs were used within 2 weeks. ? Informed consent to the purpose and content of the research. Normal control group: ? During the same period, the physical examination center of Huashan Hospital Affiliated with Fudan University, and the Dermatology Clinic of Huashan Hospital Affiliated with Fudan University were healthy people whose age, gender, and atopic dermatitis matched; ? The age of subjects is 12-60 years old, and the male-to-female ratio is 1:1.; ? No pathological symptoms and signs; ? No pathological laboratory abnormalities; ? No pathological imaging abnormalities; ? No history of serious cardiovascular system, chronic respiratory disease, allergic disease, rheumatic immune system disease, or chronic skin disease; ? Informed consent to the purpose and content of the research. ?Inclusion criteria for acne patients: ? During the same period, patients from the Dermatology Clinic of Huashan Hospital Affiliated with Fudan University who were matched in age, gender, and atopic dermatitis group met the diagnostic criteria for acne vulgaris, Pillsbury classification I-II (mild to moderate): acne, small to moderate number Papules, and pustules, the total number of lesions ranges from 0 to 50; ? The age of subjects is 12-40 years old, and the male-to-female ratio is 1:1.; ? No systemic use of glucocorticoids, retinoic acid drugs, etc. within 1 month; no systemic use of antibiotics and antifungal drugs within 1 month; no topical use of anti-inflammatory drugs such as corticosteroids, calcineurin inhibitors, etc. within 2 weeks; No topical antibiotics or antifungal drugs have been used within 2 weeks; No topical retinoids have been used within 2 weeks. No photoelectric therapy or chemical peeling treatment was performed within one month. ? No solid organ malignant tumors, no history of hematological diseases such as leukemia, bone marrow hematopoietic abnormalities; ? Informed consent to the purpose and content of the research.

Exclusion criteria

Exclusion criteria: Exclusion criteria for atopic dermatitis patients: ? Combined with other skin diseases, such as psoriasis, vitiligo, lupus erythematosus. ? Local infection at the lesion site. ? Patients with autoimmune diseases, such as rheumatoid arthritis. ? Have a history of solid organ malignant tumors, leukemia, bone marrow hematopoietic abnormalities, and other hematological diseases; ? Pregnant patients; ? Participated in other clinical trials in the past month. Exclusion criteria for the normal control group: ? Incomplete medical history information; ? Systemic use of antibiotics and antifungal drugs within the past 1 month; topical use of antibiotics or antifungal topical drugs within the past 2 weeks ? Participated in other clinical trials in the past month. Exclusion criteria for acne patients: ? Suffering from other skin diseases, such as psoriasis, vitiligo, lupus erythematosus, etc.; ? Suffering from related rheumatic diseases, such as rheumatoid arthritis; ? Suffering from other systemic infectious diseases; ? Participated in other clinical trials in the past month.

Design outcomes

Primary

MeasureTime frame
Investigator Global Assessment, IGA;Regional Eczema area and severity index (EASI);Regional Pillsbury clinical grade;

Secondary

MeasureTime frame
Transepidermal water loss, TEWL;skin hydration;skin pH;skin sebum content;

Countries

China

Contacts

Public ContactWei Li

Huashan Hospital, Fudan University

liweiderma@163.com+86 186 2935 2992

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026