Effect of the Composition From Fish on Promoting Hair Growth

NCT05450861 | Completed

• 1 other identifier: KMUHIRB-F(I)-20190142
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• hair density

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

  8 weeks

• hair diameter

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

  8 weeks

Secondary Outcomes (1)

• Dermatology Life Quality Index (DLQI) questionnaire

  8 weeks

Other Outcomes (3)

• hair density

  4 weeks

• hair diameter

  4 weeks

• DLQI questionnaire

  4 weeks

Study Arms (2)

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.

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.

Other: Placebo

Interventions

SF DNA extraction composition OTHER

the composition of small fragments of DNA from fish

SF DNA Treatment

Placebo OTHER

the scalp conditioning solution without SF DNA extraction composition

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Municipal Ta-Tung Hospital

Kaohsiung City, 80145, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 26569211 BACKGROUND

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: using scalp conditioning solution without target composition
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 11, 2022
• Study Start: February 3, 2020
• Primary Completion: February 4, 2021
• Study Completion: February 4, 2021
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)