NCT02601222

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule in treating chronic eczema.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 10, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

9 months

First QC Date

October 9, 2015

Last Update Submit

September 19, 2016

Conditions

Chronic Eczema

Keywords

chronic eczemaefficacy and safetyRunzao zhiyang capsule

Outcome Measures

Primary Outcomes (1)

  • The efficiency(The number of cured cases and cases with marked effect) of disease： Using EASI score decline rate to judge. The decline rate of EASI = (before treatment EASI- After treatment EASI)/ before treatment EASI×100%

    0,4 weeks

Secondary Outcomes (5)

  • The decrease rate of EASI in each visit compare with baseline

    0,2,4,8,12 weeks

  • Changes in the degree of pruritus（test by visual analogue scale） in the follow-up visits compared with baseline

    0,2,4,8,12 weeks

  • DLQI (Dermatology Life Quality Index) score changes during the follow-up visits compared with baseline.

    0,2,4,8,12 weeks

  • The proportion of patients (EASI score greater than 10% of the patients before treatment)

    8,12 weeks

  • EASI score

    8,12 weeks

Other Outcomes (2)

  • Safety assessments will be based on adverse event reports.

    2,4,8,12 weeks

  • Safety assessments will be based on electrocardiogram, physical examinations, and clinical laboratory tests.

    0,2,4，8，12 weeks

Study Arms (2)

Runzao zhiyang capsule

EXPERIMENTAL

Runzao zhiyang capsule: 4 pills each time, 3 times a day, oral， Urea Cream (topical application, apply to the affected area and gently rub) 2 times a day.

Drug: Runzao zhiyang capsuleDrug: Urea cream

Runzaozhiyang capsule agent simulation

PLACEBO COMPARATOR

Runzaozhiyang capsule agent simulation:4 pills each time, 3 times a day, oral, Urea Cream (topical application, apply to the affected area and gently rub) 2 times a day.

Drug: Runzaozhiyang capsule agent simulationDrug: Urea cream

Interventions

Runzao zhiyang capsuleDRUG

Runzao zhiyang capsule：4 pills each time, 3 times a day, oral. Number of Cycles：4 weeks of treatment, the cured patients were followed up for 8 weeks to evaluate recurrence.

Runzao zhiyang capsule
Runzaozhiyang capsule agent simulationDRUG

Runzaozhiyang capsule agent simulation：4 pills each time, 3 times a day, oral， Number of Cycles：4 weeks of treatment, the cured patients were followed up for 8 weeks to evaluate recurrence.

Runzaozhiyang capsule agent simulation
Urea creamDRUG

Topical application, apply to the affected area and gently rub, 2 times a day.Number of Cycles：4 weeks of treatment, the cured patients were followed up for 8 weeks to evaluate recurrence.

Runzao zhiyang capsuleRunzaozhiyang capsule agent simulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consistent with diagnostic criteria for chronic eczema(Referring to "the Chinese eczema diagnosis and treatment guidelines" in 2011);
  • Investigator Global Assessment (IGA) score was 2 or 3;
  • The skin lesions were localized, hypertrophy and dry, and the affected skin area was 3%\~10% of body surface area (estimated by palm method); the diameter of target lesions was 2\~10cm and located in the limbs or trunk.
  • The course of chronic eczema is more than 6 months;
  • Age 18 to 70, males or females;
  • The Subjects obtain informed consent, participated the trial voluntarily. Procedure to obtain informed consent is in accordance with the provisions of Good Clinical Practise(GCP).

You may not qualify if:

  • Subjects with acute eczema, subacute eczema, universal eczema, special type of eczema;
  • Subjects used corticosteroids, immunosuppressive agents and ultraviolet irradiation in 4 weeks prior to the enrollment;
  • Subjects were treated with antihistamine and topical drugs in 2 weeks;
  • Women in Pregnancy, Lactation, or Planned pregnancy during the test;
  • Comorbid with severe primary heart, liver, lung, kidney, blood disease, diabetes, thyroid disease or a serious disease affecting survival, such as cancer or HIV / AIDS;
  • Subjects were allergic to test drug ingredients;
  • Subjects could not give full informed consent because of mental and behavioral disorders;
  • Suspected or identified with a history of alcohol or drug abuse;
  • Have other diseases or conditions which may reduce the possibility of enrollment or complicate the recruiting process based on the investigator judgment. For example, working environment changed frequently led to easily lost follow-up;
  • Have been or currently enrolled in other clinical trials within 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

RECRUITING

Beijing Friendship Hospital,Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

The First Affiliated Hospital of Chongqin Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

NOT YET RECRUITING

Dermotology hospital, Chinese academy of medical science

Nanjing, Jiangsu, 210042, China

RECRUITING

Dermatology Hospital in Shandong Province

Jinan, Shandong, 250022, China

RECRUITING

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

NOT YET RECRUITING

Study Officials

  • Gu heng, M.D.

    Dermotology hospital, Chinese academy of medical science

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gu heng, M.D.

CONTACT

+86-25-85478045

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2015

First Posted

November 10, 2015

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

September 20, 2016

Record last verified: 2016-09

Locations

CN(9)