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Clinical Efficacy and Safety Study of Recombinant Humanized Collagen XVII in the Treatment of Androgenetic Alopecia

Efficacy and Safety Study of Recombinant Humanized Collagen XVII in the Treatment of Androgenetic Alopecia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085181
Enrollment
Unknown
Registered
2024-06-03
Start date
2024-06-08
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgenetic Alopecia

Interventions

Saline Control Group:Apply 0.9% sodium chloride solution topically once daily for a total of 24 weeks.
Minoxidil Control Group:For women, apply 1 ml of 5% Minoxidil Tincture topically once daily for a total of 24 weeks
for men, apply 1 ml of 5% Minoxidil Tincture topically twice daily for a total of 24 weeks
RH-ColXVII group:Apply one vial of recombinant type XVII collagen lyophilized fiber topically once daily for a total of 24 weeks
RH-ColXVII+MN group:Perform microneedling combined with topical application of one vial of recombinant humanized type XVII collagen lyophilized fiber once every two weeks for a total of 24 weeks.

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1)Patients aged 18-45 years, in generally good health, and with a confirmed diagnosis of AGA. (2)Female patients with hair loss severity corresponding to Sinclair grades II and III and male patients with hair loss severity corresponding to Hamilton-Norwood grades III-V. (3)No local use of hair growth products or other topical treatments within 3 months prior to treatment. (4)No systemic use of medications with hair growth effects within 3 months prior to treatment. (5)Fully informed about and agreeing to the treatment protocol and follow-up plan, willing to participate voluntarily, and providing signed written informed consent. (6)Good compliance, willing to participate in regular follow-ups, and willing to accept scalp tattooing if required. (7)Willing to maintain the same hairstyle and hair length during the study period and refrain from bleaching or dyeing hair.

Exclusion criteria

Exclusion criteria: (1)Other types of hair loss, such as alopecia areata, telogen effluvium, tinea capitis-induced hair loss, syphilitic alopecia, or chemotherapy-induced hair loss. (2)Patients with severe hypertension, coronary heart disease, diabetes, cranial diseases, or tumors. (3)Patients with androgen-secreting adrenal or ovarian tumors, Cushing's syndrome, or congenital adrenal hyperplasia. (4)Patients with confirmed heart, liver, kidney function impairment, or immunodeficiency. (5)Patients with scalp skin diseases affecting efficacy evaluation, such as fungal or bacterial infections, severe seborrheic dermatitis, scalp psoriasis, contact dermatitis, severe folliculitis, or scalp atrophy. (6)Patients with neuropsychiatric disorders, anemia, hypotension, thyroid disease history, polycystic ovary syndrome, or elevated blood potassium levels. (7)Patients with keloid-prone skin, coagulation disorders, pregnant or breastfeeding women, menopausal or women with menstrual disorders. (8)Patients with a history of hair transplantation, those requiring long-term use of wigs or hair bonding during the treatment period. (9)Patients planning to conceive during the study period (approximately 6 months). (10)Patients unable to adhere to the medication regimen, making efficacy evaluation impossible, or with incomplete data. (11)Patients currently participating in other clinical trials. (12)Researchers who consider the patient unsuitable for this study.

Design outcomes

Primary

MeasureTime frame
Hair density;

Secondary

MeasureTime frame
Terminal hair density;Vellus hair density;T/V ratio;HF density;Hair Diameter Diversity, HDD;Sinclair Classification Assessment (for Women), Hamilton-Norwood Classification Assessment (for Men);7-point global-assessment scale;Patient Subjective Satisfaction Assessment;Dermatology Life Quality Index, DLQI;

Countries

China

Contacts

Public ContactFenglin Zhuo

Beijing Friendship Hospital, Capital Medical University

zflsunny@hotmail.com+86 159 1089 5068

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026