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Assessing the Safety and Efficacy of Endolysin Gel in the Treatment of Adult Patients with Mild to Moderate Atopic Dermatitis

Assessing the Safety and Efficacy of Endolysin Gel in the Treatment of Adult Patients with Mild to Moderate Atopic Dermatitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101921
Enrollment
Unknown
Registered
2025-05-06
Start date
2025-05-20
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Atopic dermatitis

Interventions

Experimental group:Endolysin gel at least twice a day (after morning and evening baths) for 14 days. Subjects who completed the 14-day Endolysin gel treatment and for whom continued treatment was deem

Sponsors

Shenzhen Qianhai Shekou Free Trade Zone Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The patient or his/her guardian understands and voluntarily signs the informed consent, and is expected to complete the follow-up examination, relevant data filling and treatment of the study procedure; 2. Male or female (18-70 years old); AD that meets Hanifin's criteria (>3 essential features and >3 secondary features) and has been present for at least 6 months prior to inclusion; 3. The cohort of mild to moderate atopic dermatitis with EASI <=21 at the time of inclusion.

Exclusion criteria

Exclusion criteria: 1.Female subjects who are pregnant, nursing, or planning to become pregnant, or who have reproductive potential but are not using an effective and permitted form of contraception. 2. Active skin infections and/or systemic infections requiring systemic or topical antimicrobial agents and/or skin drainage procedures, or a history of recurrent bacterial skin infections. 3. Other concurrent skin diseases that may interfere with the diagnosis and/or treatment of AD (e.g., psoriasis, contact dermatitis), or the presence of open, chronic non-healing wounds in their treatable AD lesions. 4. Known allergy to the study drug, its excipients, and/or any emollients used in the study. 5. Used in the first 28 days before preparing to start the clinical trial: Systemic corticosteroids; Systemic JAK inhibitors and immunosuppressants; Abiotic investigation agent or device; Whole-body phototherapy; 6. Used in the first 14 days before preparing to start the clinical trial: Systemic antibiotics; Probiotics and probiotics; Prescription skin barrier repair products. 7. In preparation for the first day of clinical trial, within 7 days of use: Local treatment of AD; Topical antimicrobials and disinfectant cleansers; Use antibacterial soaps or topical sodium hypochlorite products. 8. Patients who have participated in any drug clinical trials and used experimental drugs within 3 months before screening. 9. With severe liver and kidney diseases, blood system diseases, autoimmune diseases, chronic serious infections, diabetes, mental illness, etc.; Patients with malignant tumors or other serious diseases that may affect the correct evaluation of efficacy.

Design outcomes

Primary

MeasureTime frame
Scoring Atopic Dermatitis(SCORAD);Eczema area and severity index (EASI);Investigator Global Assessment (IGA);

Secondary

MeasureTime frame
Dermatology Life Quality Index (DLQI);Visual Analogue Scale (VAS);

Countries

China

Contacts

Public ContactHu Gang; Kui Ling

Shenzhen Qianhai Shekou Free Trade Zone Hospital

kuiling2008@163.com+86 135 9015 5267

Outcome results

None listed

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