Status Approved
First Submitted Date
2020/10/07
Registered Date
2020/11/23
Last Updated Date
2021/12/29
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0005618 |
|---|---|
| Unique Protocol ID | IRB-200804T001 |
| Public/Brief Title | Double-blind, randomized and placebo-controlled clinical trial on the efficacy and safety on hair loss prevention for 24 weeks |
| Scientific Title | Double-blind, randomized and placebo-controlled clinical trial on the efficacy and safety of M-200729327-01,02 on hair loss prevention for 24 weeks |
| Acronym | |
| MFDS Regulated Study | No |
| IND/IDE Protocol | No |
| Registered at Other Registry | No |
| Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
| Board Approval Status | Submitted approval |
|---|---|
| Board Approval Number | IRB-200804T001 |
| Approval Date | 2020-09-07 |
| Institutional Review Board Name | Ellead IRB |
| Institutional Review Board Address | 325, Hwangsaeul-ro, Bundang-gu, Seongnam-si, Gyeonggi-do |
| Institutional Review Board Telephone | 031-709-9070 |
| Data Monitoring Committee | No |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | TaeKee Moon |
| Title | study director |
| Telephone | +82-31-709-9070 |
| Affiliation | Ellead |
| Address | 325,Hwangsaeul-ro, Bundang-gu, Seongnam-si, Gyeonni-do, Korea |
| Contact Person for Public Queries | |
| Name | hoyoung Jung |
| Title | researcher |
| Telephone | +82-31-709-9070 |
| Affiliation | Ellead |
| Address | 325,Hwangsaeul-ro, Bundang-gu, Seongnam-si, Gyeonni-do, Korea |
| Contact Person for Updating Information | |
| Name | Sunhwa Lee |
| Title | researcher |
| Telephone | +82-31-709-9070 |
| Affiliation | Ellead |
| Address | 325,Hwangsaeul-ro, Bundang-gu, Seongnam-si, Gyeonni-do, Korea |
4. Status
| Study Site | Single | |
|---|---|---|
| Overall Recruitment Status | Completed | |
| Date of First Enrollment | 2020-09-14 Actual | |
| Target Number of Participant | 60 | |
| Primary Completion Date | 2021-03-12 , Actual | |
| Study Completion Date | 2021-06-16 , Actual | |
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | Ellead | |
| Recruitment Status | Completed | |
| Date of First Enrollment | 2020-09-14 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | Bioneer |
| Organization Type | Others |
| Project ID | |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | Ellead |
| Organization Type | Others |
7. Study Summary
| Lay Summary | The purpose of this clinical trial is the evaluation of the efficacy and safety of test article on hair loss prevention targeting for subjects diagnosed with Androgenic-induced Alopecia |
|---|
8. Study Design
| Study Type | Interventional Study |
|---|---|
| Study Purpose | Supportive Care |
| Phase | Not applicable |
| Intervention Model | Parallel |
| Blinding/Masking | Double |
| Blinded Subject | Subject, Investigator |
| Allocation | RCT |
| Intervention Type | Others |
| Intervention Description | During the test period, volunteers are washed their scalp and hair using the provided standard shampoo and conditioner and dry them completely. According to the randomization and double-blind, Apply the test product to the hair loss area by pressing the upper part of the container once and massage the scalp thoroughly using the silion part. Repeat this process 6 to 7 times for apply the sample well to the entire scalp (including hairline and crown). The test product is applied once a week for 24 weeks. |
| Number of Arms | 2 |
| Arm 1 |
Arm Label test group |
|
Target Number of Participant 30 |
|
|
Arm Type Experimental |
|
|
Arm Description An appropriate amount of the test product is applied and gently massaged on the scalp once a week for 24 weeks. |
|
| Arm 2 |
Arm Label Placebo |
|
Target Number of Participant 30 |
|
|
Arm Type Placebo comparator |
|
|
Arm Description An appropriate amount of the test product is applied and gently massaged on the scalp once a week for 24 weeks. |
9. Subject Eligibility
| Condition(s)/Problem(s) |
* (L00-L99)Diseases of the skin and subcutaneous tissue (L64.9)Androgenic alopecia, unspecified Alopecia |
|---|---|
| Rare Disease | No |
| Inclusion Criteria |
Gender Both |
|
Age 18Year~54Year |
|
|
Description ① 18~54 years old men and women diagnosed with androgenic alopecia. ② Androgenic alopecia patients who have been diagnosed as basic type M2, C2, U1 or above, or specific type V1, F1 or above based on Basic and specific (BASP) classification for men and women, stage 3 or above on Norwood-Hamilton scale for men, and stage 1 or above on Ludwig scale for women ③ Those who do not use special hair growth products and receive hair care and surgical procedure during study period. ④ Those who are willing to maintain the same hair style, length, and color during the study period. |
|
| Exclusion Criteria |
① Those who have suffered acute renal, cardiac, or other chronic disease (hypertension or diabetes) that can affect the study results within 6 months. ② Those who are pregnant, breast feeding or planning pregnancy within the last 6 months. ③ Those who have mental disorder. ④ Those who have infectious skin disease. ⑤ Those who received surgical treatments or procedures such as hair transplant or scalp reduction. ⑥ Those who have used oral, dutasteride or finasteride within the last 6 months. ⑦ Those who have applied topical hair growth products or hair tonic to the scalp within the last 1 month. ⑧ Those who have used the following drugs within the last 1 month: steroids, apoptotic agents, vasodilators, antihypertensive drugs, antiepileptics, beta receptor blocker, bronchodilator, diuretic, spironolactone, cimetidine, diazoxide, cyclosporine, and ketoconazole. ⑨ Those who have applied topical steroids to scalp within the last 1 months. ⑩ Those who have been judged to have difficulty in applying the test product to the scalp because of severe seborrheic dermatitis, psoriasis, and infection of scalp. ⑪ Those who have other type of alopecia such as alopecia areata, telogen effluvium, and alopecia cicatrisata besides androgenic alopecia. ⑫ Those who have been judged by the study director to be unsuitable for enrollment in this clinical trial. |
| Healthy Volunteers | Yes |
10. Outcome Measure(s)
| Type of Primary Outcome | Efficacy | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | the number of hair in test area |
|
| Timepoint | baseline, 16 weeks, 24 weeks |
|
| Secondary Outcome(s) 1 | ||
| Outcome | Visual assessment according to the BASP classification by Expert |
|
| Timepoint | 8 weeks, 16weeks, 24weeks |
|
11. Study Results and Publication
| Result Registered |
Yes
Results Upload |
|---|---|
| Final Enrollment Number | 43 |
| Number of Publication | 0 |
| Results Upload | EL-200729327 results.pdf |
| Date of Posting Results | 2021/12/29 |
| Protocol URL or File Upload | EL-200729327 protocol.pdf |
| Brief Summary | The results of assessment of the number of hairs in the shaved area by phototrichogram showed an increase in the number of hairs in Group A after 16 and 24 weeks of application with statistical significance (p<0.001). Also, the results showed a greater increase in the number of hairs in Group A compared with Group B after 24 weeks of application with statistical significance (p<0.05). The results of visual assessment on the degree of hair loss relief by two researchers (experts) showed a greater improvement (score) in Group A compared with Group B after 16 weeks and 24 weeks of application with statistical significance (p<0.05). Therefore, Sample A was proven to help in hair loss relief after 24 weeks of application. |
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | No |
|---|
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