Status Approved
First Submitted Date
2016/08/12
Registered Date
2016/09/13
Last Updated Date
2017/05/31
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0002060 |
|---|---|
| Unique Protocol ID | ISEE_2015_JWG |
| Public/Brief Title | Efficacy, safety and dose finding trial of topical Jaungo application in atopic dermatitis patients: a randomized, double-blind, placebo-controlled study |
| Scientific Title | Efficacy, safety and dose finding trial of topical Jaungo application in atopic dermatitis patients: a randomized, double-blind, placebo-controlled study |
| Acronym | |
| MFDS Regulated Study | Yes |
| IND/IDE Protocol | Yes |
| Registered at Other Registry | No |
| Healthcare Benefit Approval Status |
2. Institutional Review Board / Ethics Committee
| Board Approval Status | Submitted approval |
|---|---|
| Board Approval Number | KOMCIRB-160617-HR-027 |
| Approval Date | 2016-07-22 |
| Institutional Review Board Name | Institutional Review Board of Kyung Hee university korean medicine hospital |
| Institutional Review Board Address | |
| Institutional Review Board Telephone | |
| Data Monitoring Committee |
Yes
Institute of safety and effectiveness evaluation for Korean medicine, Kyung Hee university |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | Younghee Yun |
| Title | Clinic. assis. prof. |
| Telephone | +82-2-958-9177 |
| Affiliation | Kyung Hee University Oriental Medicine Hospital at Gangdong |
| Address | Dongnamro 892, Gangdonggu, Seoul |
| Contact Person for Public Queries | |
| Name | Jinhyang Ahn |
| Title | resident |
| Telephone | |
| Affiliation | Kyung Hee University Oriental Medicine Hospital at Gangdong |
| Address | Dongnamro 892, Gangdonggu, Seoul |
| Contact Person for Updating Information | |
| Name | Jinhyang Ahn |
| Title | resident |
| Telephone | |
| Affiliation | Kyung Hee University Oriental Medicine Hospital at Gangdong |
| Address | Dongnamro 892, Gangdonggu, Seoul |
4. Status
| Study Site | Single | |
|---|---|---|
| Overall Recruitment Status | Recruiting | |
| Date of First Enrollment | 2016-09-20 Actual | |
| Target Number of Participant | 34 | |
| Primary Completion Date | 2016-12-31 , Anticipated | |
| Study Completion Date | 2016-12-31 , Anticipated | |
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | Kyung Hee University Oriental Medicine Hospital at Gangdong | |
| Recruitment Status | Recruiting | |
| Date of First Enrollment | 2016-09-20 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | Ministry of Health & Welfare |
| Organization Type | Government |
| Project ID | HI13C0530 |
| 2. Source of Monetary/Material Support | |
| Organization Name | Ministry of Health & Welfare |
| Organization Type | Government |
| Project ID | HI12C1889 |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | Kyung Hee University Oriental Medicine Hospital at Gangdong |
| Organization Type | Medical Institute |
7. Study Summary
| Lay Summary | Atopic Dermatitis is a chronic relapsing eczematous skin disease with increasing prevalence. Complementary and alternative medical approaches have been employed to relieve symptoms of Atopic Dermatitis. We aim to establish basic clinical efficacy and safety data for Jaungo in patients with Atopic Dermatitis. This study is a randomised, double blind, placebo-controlled, single-centre trial with three parallel arms (trial group 1, trial group 2, and control group). The diagnosis of Atopic Dermatitis will be made according to the criteria of Hanifin and Rajka. Participants will receive Jaungo or a placebo-drug for three weeks. Participants in trial group 1 will apply Jaungo and placebo to the lesion once a day for three weeks. Participants in trial group 2 will apply Jaungo to the lesion twice a day for three weeks. Participants in control group will apply placebo to the lesion twice a day for three weeks. Each participant will be examined for EASI (Eczema area and severity index), SCORAD (SCORing of Atopic Dermatitis), TEWL (Transepidermal water loss) and DLQI (Dermatology Life Quality Index) before and after applying medication. The outcomes to evaluate the maintenance of safety are Draize score, blood test and expert's opinion. |
|---|
8. Study Design
| Study Type | Interventional Study |
|---|---|
| Study Purpose | Treatment |
| Phase | Phase2 |
| Intervention Model | Parallel |
| Blinding/Masking | Double |
| Blinded Subject | Subject, Investigator |
| Allocation | RCT |
| Intervention Type | Drug |
| Intervention Description | This study is a randomised, double blind, placebo-controlled, single-centre trial with three parallel arms (trial group 1, trial group 2, and control group). Participants in trial group 1 will apply Jaungo and placebo to the lesion once a day for three weeks. Participants in trial group 2 will apply Jaungo to the lesion twice a day for three weeks. Participants in control group will apply placebo to the lesion twice a day for three weeks. |
| Number of Arms | 3 |
| Arm 1 |
Arm Label trial group 1 |
|
Target Number of Participant 12 |
|
|
Arm Type Experimental |
|
|
Arm Description Participants will receive Jaungo and placebo once a day for three weeks. |
|
| Arm 2 |
Arm Label trial group 2 |
|
Target Number of Participant 11 |
|
|
Arm Type Experimental |
|
|
Arm Description Participants will receive Jaungo twice a day for three weeks. |
|
| Arm 3 |
Arm Label control group |
|
Target Number of Participant 11 |
|
|
Arm Type Placebo comparator |
|
|
Arm Description Participants will receive placebo twice a day for three weeks. |
9. Subject Eligibility
| Condition(s)/Problem(s) |
* (L00-L99)Diseases of the skin and subcutaneous tissue (L20.9)Atopic dermatitis, unspecified |
|---|---|
| Rare Disease | No |
| Inclusion Criteria |
Gender Both |
|
Age 5Year~65Year |
|
|
Description 1) The diagnosis of AD will be made according to the criteria of Hanifin and Rajka 2) Age: 5 years to 65 years 3) objective SCORAD ≦40, Diagnosis of Mild to Moderate Atopic Dermatitis (AD) 4) Exoriation≥1, Lichenification≥1, Dryness≥1 or Exoriation+Lichenification+Dryness≥3 5) Participants who able to express intention 6) Participants willing to provide written informed consent |
|
| Exclusion Criteria |
1) Participants have oozing in the lesion 2) Users of following medications prior to trial periods ① Oral steroids, immunosuppressants and antibiotics within 4 weeks prior to this trial ② Topical steroids, immunosuppressants and antibiotics within 2 weeks prior to this trial ③ Light therapy within 2 weeks prior to this trial ④ Other medications thought to be inappropriate by researchers 3) Participants have severe burn or wide wound 4) Participants have oozing or ulcer in the lesion 5) Allergic reactions to Angelica gigas, Siebold et Zuccarini, sesame oil and lard 6) Participants have skin disease except atopic dermatitis 7) Participants have severe renal function disease (sCr > 2.0 mg/dL) 8) Participants have severe liver function disease (ALT, AST, ALP ≥ 2.5 × normal limits) 9) Participants have uncontrolled chronic diseases 10) Pregnancy, lactation 11) Participation in another clinical trial within one month of enrolment 12) Underlying disease or history of severe disease, abnormal state (paralysis; mental retardation other emotional or mental problems; diseases that can affect the absorption of drugs; no enough time to participate in this trial; visual disturbance and hearing impairment; inability to understand written consent or engage in this study) 13) Judgment by experts that the potential subject’s participation is inappropriate. |
| Healthy Volunteers | No |
10. Outcome Measure(s)
| Type of Primary Outcome | /Safety/Efficacy | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | EASI (Eczema area and severity index) |
|
| Timepoint | visit 2, visit 3 |
|
| Secondary Outcome(s) 1 | ||
| Outcome | SCORAD (SCORing of Atopic Dermatitis) |
|
| Timepoint | visit 2, visit 3 |
|
| Secondary Outcome(s) 2 | ||
| Outcome | TEWL (Transepidermal water loss) |
|
| Timepoint | visit 2, visit3 |
|
| Secondary Outcome(s) 3 | ||
| Outcome | DLQI (Dermatology Life Quality Index) |
|
| Timepoint | visit 2, visit 3 |
|
| Secondary Outcome(s) 4 | ||
| Outcome | Total IgE, eosinophil count, IL-17, IL-22, IFN-γ |
|
| Timepoint | visit 1, visit 3 |
|
| Secondary Outcome(s) 5 | ||
| Outcome | The clinical phenotype evaluation system of atopic dermatitis |
|
| Timepoint | visit 2 |
|
11. Study Results and Publication
| Result Registered |
|---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | Not provided at time of Registration |
|---|
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