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Single-Arm Clinical Trial of Local Mini-Incision Suture for the Treatment of Inflammatory Skin Diseases of the Vulva and Perianal Region

Single-Arm Clinical Trial of Local Mini-Incision Suture for the Treatment of Inflammatory Skin Diseases of the Vulva and Perianal Region

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122809
Enrollment
Unknown
Registered
2026-04-17
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Inflammatory Skin Diseases of the Vulva and Perianal Region

Interventions

Trial Group:Local small incision and suture method for treating inflammatory skin diseases of the vulva and perianal area

Sponsors

ZhuJiang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Participants voluntarily consented to the study and signed an informed consent for; 2. Female, aged 18 <= age <= 70 years. 3. It meets the diagnostic criteria for sclerosing caress, chronic simple caress or atopic dermatitis. 4. All systemic and topical treatments were discontinued 10 weeks prior to trial initiation.

Exclusion criteria

Exclusion criteria: 1. Patients with infectious diseases such as candidal infection, bacterial vaginosis, gonorrhea, or non-gonococcal urethritis; 2. Those with diabetes, chronic liver disease, chronic kidney disease, or autoimmune diseases; 3. Pregnant or breastfeeding women; 4. Patients using immunosuppressants or immunomodulatory drugs for other conditions; 5. Individuals deemed unsuitable for the trial by the investigator; 6. Those unable to attend regular follow-ups, who have not signed the informed consent form, or who have mental health conditions such as anxiety disorders or obsessive-compulsive disorder.

Design outcomes

Primary

MeasureTime frame
SCORAD Score at Week 8;

Secondary

MeasureTime frame
Weekly SCORAD Score from Week 1 to Week 7;Relapse Rate at 6 Months Post-Treatment;

Countries

China

Contacts

Public ContactYu Lei

ZhuJiang Hospital of Southern Medical University

Xiaoyu927@smu.edu.cn+86 135 8036 2520

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026