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Effect of the Composition From Fish on Promoting Hair Growth

Primary Purpose

Hair Loss/Baldness, Androgenic Alopecia, Male Pattern Baldness

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
SF DNA extraction composition
Placebo
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hair Loss/Baldness focused on measuring Hair Loss/Baldness, Androgenic Alopecia, male pattern baldness, female pattern alopecia, sfDNA

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients within 20~75 years old.
  • Diagnosed with alopecia by dermatologists.
  • Willing to maintain the same hair style, color, shampoo and hair products used, and approximate hair length starting from signing ICF and throughout the study.
  • The subject can understand and obey order.

Exclusion Criteria:

  • Pregnant, nursing, or planning a pregnancy during the study.
  • Use of any topical medication (such as minoxidil or any other solution for hair growth), laser therapy, or chemotherapy, within the preceding 4 weeks.
  • Personal medical history of abnormal blood clotting such as bleeding disorders or platelet dysfunction syndrome.
  • Personal medical history of unstable vital signs such as hypotension or uncontrolled hypertension syndrome.
  • Prior hair transplant.
  • Chronic scalp disorders that require medications.
  • Uses medication known to cause hair thinning such as Coumadin and anti- depressants/anti-psychotics.
  • Existing scalp diseases such as folliculitis, scalp psoriasis, seborrheic dermatitis, or inflammatory scalp conditions.
  • Enrolled in any other medical study or has been enrolled in any medical study in the past 6 months.
  • Any hematologic abnormalities.
  • Severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies.
  • Planned upcoming surgeries.
  • Tattoo on scalp.

Sites / Locations

  • Kaohsiung Municipal Ta-Tung Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SF DNA Treatment

Placebo

Arm Description

the scalp conditioning solution with SF DNA extraction composition is applied daily and combination with hair loss medical treatment for eight weeks.

the scalp conditioning solution without SF DNA extraction composition is applied daily and combination with hair loss medical treatment for eight weeks.

Outcomes

Primary Outcome Measures

hair density
using the hair scalp analysis device to measure hair density at the vertex baldness site.
hair diameter
using the hair scalp analysis device to measure hair diameter at the vertex baldness site.

Secondary Outcome Measures

Dermatology Life Quality Index (DLQI) questionnaire
Participants answered the DLQI questionnaire by self. Higher scores mean a worse outcome (poor quality of life).

Full Information

First Posted
July 5, 2022
Last Updated
July 8, 2022
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05450861
Brief Title
Effect of the Composition From Fish on Promoting Hair Growth
Official Title
Effect of the Composition From Fish on Promoting Hair Growth
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
February 4, 2021 (Actual)
Study Completion Date
February 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
According to the World Health Organization data, one out of every five Chinese men has a hair loss symptom, and the hair loss is as high as 84% before the age of 30. Based on the experience of clinicians, there seems to be an increasing trend of alopecia patients who seek the treatment in Taiwan. Treating pathological hair loss requires prompt diagnosis and management to prevent conditions that could lead to permanent hair loss. The current methods of treating hair loss include oral drugs, topical medication, laser illuminating treatment, platelet-rich plasma and hair transplant surgery. However, these treatments also have different disadvantages. Prolonged continuous use of oral and topical medications may be accompanied by side effects. Other treatment modalities may require higher costs, require return visits, or be more invasive. Previous study found that the composition of small DNA fragments (SF DNA) possesses not only toxin-free in primary human skin cells and nude mice, but also inhibits inflammation and ROS generation in the process of skin aging. SF DNA also contributes to promote the proliferation and differentiation of hair follicles, and stimulates the hair growth in nude mice through affecting JAK-STAT pathway. The investigators hypothesize that the clinical application of SF DNA scalp conditioning solution attenuates inflammatory responses, promotes the proliferation and differentiation of hair follicles, and increases the hair of hair loss patients and inspires the quality of life.
Detailed Description
Thick and healthy hair is a symbol, representing the attractiveness, youth, health and fertility of adults. However, according to the World Health Organization data, one out of every five Chinese men has a hair loss symptom, and the hair loss is as high as 84% before the age of 30. Based on the experience of clinicians, there seems to be an increasing trend of alopecia patients who seek the treatment in Taiwan. Excessive hair shedding potentially distributes to physiological effect which is in the senile hair-loss/postpartum state, or pathological effect which is due to thyroid disturbances, trauma, lupus erythematosus, scleroderma, drug effects, iron deficiency, or fungal infection. There are also two kinds of pathological hair loss, alopecia areata and androgen-derived hair loss, both of them are difficult to treatment in clinical so far. First-line interventions for treating excessive hair shedding include lifestyle modification and behavior therapy, such as clean scalp, adjusted daily routine, and alleviated psychological stress. The second-line interventions is drug therapy which is helpful in the treatment of excessive hair shedding, but respond to conservative measures. The minoxidil application is an effective treatment for androgenetic alopecia in both men and women. Its side effects include redness and scaling of the scalp. The finasteride reduces the dihydrotestosterone (DHT) in the serum and scalp, but it may cause sexual dysfunction. However, laser illuminating treatment, platelet-rich plasma (PRP) treatment, and surgical (hair transplant surgery) are cataloged to third-line interventions. The PRP treatment is safe, rapid, and process tolerable, and has the advantage of being finer and relatively low-cost compared to hair transplantation. Follicular units pre-treatment by PRP also facilitate increase of the survival rate of transplanted hair. Although light therapy does not have the side effects of percutaneous or oral administration, treatment with two to three times a week can also cause problems for patients. Autologous hair transplantation is a supplementary treatment for advanced androgenetic alopecia. However, the cost of hair transplantation is high, and the survival rate of hair after transplantation is also worrying. In addition, surgery during convalescence also produces the costs of hospitalization and the loss of productivity. These problems are worthwhile for most patients with excessive hair shedding. To minimize invasiveness treatment, the efficacy, safety, and cost-effectiveness should be considered. Our previous study found that the composition of small DNA fragments (SF DNA) possesses not only toxin-free in primary human skin cells and nude mice, but also inhibits inflammation and ROS generation in the process of skin aging. SF DNA also contributes to promote the proliferation and differentiation of hair follicles, and stimulates the hair growth in nude mice through affecting JAK-STAT pathway. The investigators hypothesize that the clinical application of SF DNA scalp conditioning solution attenuates inflammatory responses, promotes the proliferation and differentiation of hair follicles, and increases the hair of hair loss patients and inspires the quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hair Loss/Baldness, Androgenic Alopecia, Male Pattern Baldness, Female Pattern Alopecia
Keywords
Hair Loss/Baldness, Androgenic Alopecia, male pattern baldness, female pattern alopecia, sfDNA

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
using scalp conditioning solution without target composition
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SF DNA Treatment
Arm Type
Experimental
Arm Description
the scalp conditioning solution with SF DNA extraction composition is applied daily and combination with hair loss medical treatment for eight weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
the scalp conditioning solution without SF DNA extraction composition is applied daily and combination with hair loss medical treatment for eight weeks.
Intervention Type
Other
Intervention Name(s)
SF DNA extraction composition
Intervention Description
the composition of small fragments of DNA from fish
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
the scalp conditioning solution without SF DNA extraction composition
Primary Outcome Measure Information:
Title
hair density
Description
using the hair scalp analysis device to measure hair density at the vertex baldness site.
Time Frame
8 weeks
Title
hair diameter
Description
using the hair scalp analysis device to measure hair diameter at the vertex baldness site.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Dermatology Life Quality Index (DLQI) questionnaire
Description
Participants answered the DLQI questionnaire by self. Higher scores mean a worse outcome (poor quality of life).
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
hair density
Description
using the hair scalp analysis device to measure hair density at the vertex baldness site.
Time Frame
4 weeks
Title
hair diameter
Description
using the hair scalp analysis device to measure hair diameter at the vertex baldness site.
Time Frame
4 weeks
Title
DLQI questionnaire
Description
Participants answered the DLQI questionnaire by self. Higher scores mean a worse outcome (poor quality of life).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients within 20~75 years old. Diagnosed with alopecia by dermatologists. Willing to maintain the same hair style, color, shampoo and hair products used, and approximate hair length starting from signing ICF and throughout the study. The subject can understand and obey order. Exclusion Criteria: Pregnant, nursing, or planning a pregnancy during the study. Use of any topical medication (such as minoxidil or any other solution for hair growth), laser therapy, or chemotherapy, within the preceding 4 weeks. Personal medical history of abnormal blood clotting such as bleeding disorders or platelet dysfunction syndrome. Personal medical history of unstable vital signs such as hypotension or uncontrolled hypertension syndrome. Prior hair transplant. Chronic scalp disorders that require medications. Uses medication known to cause hair thinning such as Coumadin and anti- depressants/anti-psychotics. Existing scalp diseases such as folliculitis, scalp psoriasis, seborrheic dermatitis, or inflammatory scalp conditions. Enrolled in any other medical study or has been enrolled in any medical study in the past 6 months. Any hematologic abnormalities. Severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies. Planned upcoming surgeries. Tattoo on scalp.
Facility Information:
Facility Name
Kaohsiung Municipal Ta-Tung Hospital
City
Kaohsiung
ZIP/Postal Code
80145
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26569211
Citation
Hsu WL, Lu JH, Noda M, Wu CY, Liu JD, Sakakibara M, Tsai MH, Yu HS, Lin MW, Huang YB, Yan SJ, Yoshioka T. Derinat Protects Skin against Ultraviolet-B (UVB)-Induced Cellular Damage. Molecules. 2015 Nov 12;20(11):20297-311. doi: 10.3390/molecules201119693.
Results Reference
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Effect of the Composition From Fish on Promoting Hair Growth

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