Clinical trial NCT05450861: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hair Loss/Baldness
Androgenic Alopecia
Male Pattern Baldness
Female Pattern Alopecia
Keywords: Hair Loss/Baldness
Androgenic Alopecia
male pattern baldness
female pattern alopecia
sfDNA
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 53
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: hair density
timeFrame: 8 weeks
measure: hair diameter
timeFrame: 8 weeks
Secondary outcomes:
measure: Dermatology Life Quality Index (DLQI) questionnaire
timeFrame: 8 weeks
Other outcomes:
measure: hair density
timeFrame: 4 weeks
measure: hair diameter
timeFrame: 4 weeks
measure: DLQI questionnaire
timeFrame: 4 weeks
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Municipal Ta-Tung Hospital
Study officials:
References:
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.