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
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.
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.
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 →Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.
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Exclusion Criteria:
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
the scalp conditioning solution without SF DNA extraction composition is applied daily and combination with hair loss medical treatment for eight weeks.
Other: Placebo
the composition of small fragments of DNA from fish
the scalp conditioning solution without SF DNA extraction composition
hair density
using the hair scalp analysis device to measure hair density at the vertex baldness site.
Time frame: 8 weeks
hair diameter
using the hair scalp analysis device to measure hair diameter at the vertex baldness site.
Time frame: 8 weeks
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
hair density
using the hair scalp analysis device to measure hair density at the vertex baldness site.
Time frame: 4 weeks
hair diameter
using the hair scalp analysis device to measure hair diameter at the vertex baldness site.
Time frame: 4 weeks
DLQI questionnaire
Participants answered the DLQI questionnaire by self. Higher scores mean a worse outcome (poor quality of life).
Time frame: 4 weeks
Plan to share: No
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Kaohsiung Medical University Chung-Ho Memorial Hospital