Status:
COMPLETED
A Phase Ⅱ Study of Hemay808 for Atopic Dermatitis Patients
Lead Sponsor:
Tianjin Hemay Pharmaceutical Co., Ltd
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Assess Hemay808 concentration of 1%/3%/7% for treatment of mild and moderate adult atopic dermatitis patients.
Eligibility Criteria
Inclusion
- ≥18 years old and ≤65 years old, gender is not limited;
- It met the diagnostic criteria for atopic dermatitis (AD) of Hanifin\&Rajka, and the history of AD before screening was ≥6 months;
- The investigator's overall score (IGA) at the screening period/baseline visit was 2-3;
- The skin lesion area of atopic dermatitis (excluding scalp lesions) is 3%-20% of body surface area (BSA) and suitable for local treatment;
- During the study period and within 3 months after the last administration, fertile female subjects and male subjects who did not receive vasectomy were required to take effective contraceptive measures;
- Those who have full knowledge of the test, participate in the test voluntarily and sign the informed consent.
Exclusion
- The lesion area of AD is infected and requires local or systematic treatment with anti-infective drugs, or external administration of strong or potent glucocorticoids (see annex 4) or systematic administration of glucocorticoids to control AD Useing of systemic glucocorticoids and/or immunosuppressants within 4 weeks; Or sunbathing, phototherapy (including ultraviolet therapy, photochemotherapy, etc.); Or systematic use of traditional Chinese medicine or natural medicine for the purpose of treating atopic dermatitis;
- The AD lesion area was marked, tattooed, or hyperpigmented, and was judged by the investigator to interfere with the evaluation of the response to the study's drug therapy;
- Previous use of systemic or local pde-4 inhibitors;
- Suffering from clinically significant active systemic infections;
- 2 times the normal upper limit of ALT or AST \>, or the normal upper limit of Cr and \> of renal function (study allowed 1 reexamination, excluded if still not meeting the inclusion requirements);
- Unwilling to limit their excessive uv exposure during the study period (e.g., sunbathing and/or tanning devices);
- Received the following treatment in the limited time period prior to baseline evaluation:
- . Received biologic therapy (including intravenous immunoglobulin) within 12 weeks or 5 half-lives, whichever is greater;
- . Use of systemic glucocorticoids and/or immunosuppressants within 4 weeks; Or sunbathing, phototherapy (including ultraviolet therapy, photochemotherapy, etc.); Or systematic use of traditional Chinese medicine or natural medicine for the purpose of treating atopic dermatitis;
- . The following treatment was administered within 2 weeks: systemic anti-infective drugs (both oral and intravenous); Or local use of glucocorticoid or local use of calcineurin inhibitor; Local use of traditional Chinese medicine or natural medicine for the purpose of treating atopic dermatitis; Or other topical drugs for the treatment of atopic dermatitis \[zinc oxide oil (paste), black bean oil ointment, doxepin cream, etc.\];
- . Local anti - microbial preparation was used within 1 week;
- Suffering from serious diseases of the central nervous system, cardiovascular system, respiratory system, liver, kidney, gastrointestinal system, urinary system, endocrine system or blood system, and the researcher believes that may confused result or affect the safety of the subjects;
- Suffering from a serious mental illness or other condition that affects research compliance and may interfere with the conduct of clinical trials;
- A history of malignant tumor;
- With a history of severe allergic reactions to skin topical preparations (including angioedema, allergic reactions, etc.) or known allergic reactions to Hemay808 accessories;
- Screening people who had a long history of drug abuse or alcohol abuse in the first 6 months;
- Female subjects who are suspected to be pregnant, lactating or preparing for pregnancy during the test;
- The subject plans to undergo surgery requiring hospitalization or surgery during his or her participation in the study;
- Those who participated in clinical studies of other drugs/devices and used experimental drugs/devices within the last 3 months of randomized enrollment;
- Other conditions made the researchers considered inappropriate for the study.
Key Trial Info
Start Date :
April 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2021
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT04352595
Start Date
April 24 2020
End Date
April 2 2021
Last Update
March 1 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Dermotology hospital, Chinese academy of medical science
Nanjing, Jiangsu, China, 210042
2
Ningbo second hospital
Ningbo, Zhejiang, China, 315010