CClinicalTrials.gg
CompletedNCT05450861Updated Jul 11, 2022

Effect of the Composition From Fish on Promoting Hair Growth

An interventional study of SF DNA extraction composition and Placebo in Hair Loss/Baldness, Androgenic Alopecia and Male Pattern Baldness, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-11.

Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Feb 2020, registered Jul 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Hair Loss/Baldness
  • Androgenic Alopecia
  • Male Pattern Baldness
  • Female Pattern Alopecia

Keywords

  • Hair Loss/Baldness
  • Androgenic Alopecia
  • male pattern baldness
  • female pattern alopecia
  • sfDNA
03

In context

Alopecia

609 studies on the registry are indexed under Alopecia; 131 are open to participants now.

This study's enrollment of 53 is above the median of 45 across 513 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    SF DNA Treatment

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

    Other: SF DNA extraction composition

  • Placebo comparator
    Placebo

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

    Other: Placebo

Interventions

  • OtherSF DNA extraction composition

    the composition of small fragments of DNA from fish

  • OtherPlacebo

    the scalp conditioning solution without SF DNA extraction composition

06

What researchers measure

Primary outcomes

  1. hair density

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

    Time frame: 8 weeks

  2. hair diameter

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

    Time frame: 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).

    Time frame: 8 weeks

Other outcomes

  1. hair density

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

    Time frame: 4 weeks

  2. hair diameter

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

    Time frame: 4 weeks

  3. DLQI questionnaire

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

    Time frame: 4 weeks

07

Study locations

1 site
  • Kaohsiung Municipal Ta-Tung Hospital
    Kaohsiung, 80145, Taiwan
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05450861
Lead sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Responsible party
Sponsor
First posted
Jul 11, 2022
Start date
Feb 3, 2020
Primary completion
Feb 4, 2021
Completion
Feb 4, 2021
Last update
Jul 11, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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