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Clinical study of "Reconcile skin Antipruritic Lotion"

Clinical study on the relief of skin reactions caused by tumor immunosuppressants with "Reconcile skin Antipruritic Lotion"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000183
Enrollment
Unknown
Registered
2025-01-25
Start date
2025-02-05
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Skin reactions related to tumor immunotherapy

Interventions

control group:Basic treatment+ "Reconcile skin Antipruritic Lotion" placebo
test group: Basic treatment+ "Reconcile skin Antipruritic Lotion"

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with advanced malignant tumors diagnosed clinically or pathologically; 2. Currently using Trastuzumab for treatment; 3. Age = 18 years old = 80 years old; 4. Prior to this experiment all indicators (blood routine /biochemistry/ urine routine etc.) were evaluated and found to be normal or clinically insignificant; 5. The evaluation criteria for irAEs on the skin are clear including clinical symptoms laboratory indicators or imaging evaluations. The rash grading is G1-G2; 6. Informed consent and voluntary participation of researchers.

Exclusion criteria

Exclusion criteria: 1. Severe heart liver kidney and other organic diseases as well as autoimmune diseases (blood creatinine clearance rate<30ml/min alanine aminotransferase = 2.5 times the upper limit of normal total bilirubin = 1.5 times the upper limit of normal; chronic heart failure heart function grade III or above); 2. Patients undergoing organ transplantation; 3. Adverse skin reactions caused by autoimmune skin diseases etc; (1) Serious heart liver kidney and other organic diseases as well as autoimmune diseases (blood creatinine clearance rate<30ml/min alanine aminotransferase = 2.5 times the upper limit of normal total bilirubin = 1.5 times the upper limit of normal; chronic heart failure heart function grade III or above); 4. Patients with severe mental illness; 5. Pregnant and lactating women; 6. Allergic constitution patients; 7. Patients who are currently participating in other similar clinical trials; 8.Individuals with cognitive comprehension and language expression impairments.

Design outcomes

Primary

MeasureTime frame
Visual Analog Scale score;

Secondary

MeasureTime frame
Clinical Overall Impression Scale;Traditional Chinese Medicine Main Symptom Score;Dermatology Life Quality Index;

Countries

China

Contacts

Public ContactGuiya Liao

Guangdong Provincial Hospital of Traditional Chinese Medicine

liaoguiya_ya@126.com18925003796

Outcome results

None listed

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