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Evaluation of the safety and efficacy of topical CICAPLAST BAUME B5+ in the treatment of hand foot syndrome/hand foot skin reaction related to oncotherapy in cancer patients, a single center, open label, controlled clinical study

Evaluation of the safety and efficacy of topical CICAPLAST BAUME B5+ in the treatment of hand foot syndrome/hand foot skin reaction related to oncotherapy in cancer patients, a single center, open label, controlled clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101106
Enrollment
Unknown
Registered
2025-04-21
Start date
2024-11-19
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Hand-foot syndrome/Hand-foot skin reaction

Interventions

Intervention group:Hands and feet: treat with CICAPLAST BAUME B5 twice a day
Control group:Treat with Urea Ointment twice a day

Sponsors

Rui Jin Hospital, School of Medicine, Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) 18-85 years old, ECOG 0-2 score, cancer patients undergoing treatment. 2) Hand-foot reaction/hand-foot syndrome after tumor treatment include cytotoxic chemotherapy and molecular targeted drugs. 3) Patients voluntarily participate in clinical observation and sign informed consent, willing to cooperate with follow-up observation, with good communication skills and understanding skills 4) CTCAE grading greater than or equal to 2 points 5) Initial itching or pain VAS>3 points 6) During follow-up throughout the study, participants stopped using their usual emollients.

Exclusion criteria

Exclusion criteria: 1) Severe skin infection; 2) Allergic to the ingredients of the repair agent used in the study; 3) Serious heart, brain, lung, liver, kidney damage 4) Pregnant and lactating women 5) History of mental and psychiatric disorders and a recent history of alcohol or drug abuse 6) Being treated with radiation 7) Subjects may not be able to complete the study for other reasons or may not be considered appropriate by the investigator to participate in the study

Design outcomes

Primary

MeasureTime frame
CTCAE grading improvement rate of Hand-Foot Syndrome;

Secondary

MeasureTime frame
VAS (pain);Transdermal water loss(TEWL);Skin hydration (Corneometer);VAS;Tumor Treatment Dose Maintenance Rate;Variation in Treatment Response Time;HF-QOL;Social Stigmatization PUDH-D questionnaire;

Countries

China

Contacts

Public ContactMeng Pan/Hua Cao

Rui Jin Hospital, School of Medicine, Shanghai Jiao Tong University

drcaohua@126.com+86 136 4176 9229

Outcome results

None listed

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