Hair Loss/BaldnessNCT05450861
Effect of the Composition From Fish on Promoting Hair Growth
A study testing SF DNA extraction composition in people with Hair Loss/Baldness and Androgenic Alopecia, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hair Loss/Baldness, Androgenic Alopecia, Male Pattern Baldness
- What is being tested?
- SF DNA extraction composition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Feb 2020to 4 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Being tested
- SF DNA extraction composition, Placebo
- Keywords
- Hair Loss/Baldness, Androgenic Alopecia, male pattern baldness, female pattern alopecia, sfDNA
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SF DNA extraction compositionOther
the composition of small fragments of DNA from fish
PlaceboOther
the scalp conditioning solution without SF DNA extraction composition
| Study group | Role | What they receive |
|---|---|---|
| SF DNA Treatment | Experimental | the scalp conditioning solution with SF DNA extraction composition is applied daily and combination with hair loss medical treatment for eight weeks. Receives: Other: SF DNA extraction composition |
| Placebo | Placebo comparator | the scalp conditioning solution without SF DNA extraction composition is applied daily and combination with hair loss medical treatment for eight weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
hair density
using the hair scalp analysis device to measure hair density at the vertex baldness site.
Measured: 8 weeks
hair diameter
using the hair scalp analysis device to measure hair diameter at the vertex baldness site.
Measured: 8 weeks
Secondary outcomes (1)
Dermatology Life Quality Index (DLQI) questionnaire
Participants answered the DLQI questionnaire by self. Higher scores mean a worse outcome (poor quality of life).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start3 Feb 2020
- Primary completion4 Feb 2021
- Study completion4 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hair Loss/BaldnessStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450861
- Sponsor's protocol ID
- KMUHIRB-F(I)-20190142
- Status last verified
- Jul 2022
- First submitted
- 5 Jul 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26569211
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Composition From Fish on Promoting Hair Growth
- ClinicalTrials.gov ID
- NCT05450861
- Acronym / sponsor ID
- KMUHIRB-F(I)-20190142
- Keywords
- Hair Loss/Baldness, Androgenic Alopecia, male pattern baldness, female pattern alopecia, sfDNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SF DNA Treatment | Experimental | Other: SF DNA extraction compositionthe scalp conditioning solution with SF DNA extraction composition is applied daily and combination with hair loss medical treatment for eight weeks. |
| Placebo | Placebo comparator | Other: Placebothe scalp conditioning solution without SF DNA extraction composition is applied daily and combination with hair loss medical treatment for eight weeks. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SF DNA extraction compositionthe composition of small fragments of DNA from fish | Other | SF DNA Treatment |
| Placebothe scalp conditioning solution without SF DNA extraction composition | Other | Placebo |
Primary outcome
hair density
Time frame: 8 weeks
using the hair scalp analysis device to measure hair density at the vertex baldness site.
hair diameter
Time frame: 8 weeks
using the hair scalp analysis device to measure hair diameter at the vertex baldness site.
1 secondary outcome
Dermatology Life Quality Index (DLQI) questionnaire
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Background: PubMed 26569211Hsu 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.
- Individual participant dataSharing planned: No
Related trials for Hair Loss/Baldness
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Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-Growth
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SF DNA extraction composition in people with Hair Loss/Baldness and Androgenic Alopecia, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hair density (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05450861, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.