NCT01501617Unknown1 期
The Clinical Effects of HSC (Hair Stimulating Complex) on Hair Growth in Androgenetic Alopecia: A Phase I/II Clinical Trial
Histogen1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2011年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Systemic safety measures will be assessed by measuring vital signs, adverse experiences, laboratory tests (hematology, clinical chemistry and urinalysis)and immunological response (anti-drug antibodies)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy in relation to dosing in the administration of Hair Stimulating Complex (HSC) in healthy men. HSC will be injected intradermally in the scalps of men with male pattern baldness (i.e. androgenetic alopecia).
详细描述
HSC consists of proteins secreted by human dermal cells under proprietary culture conditions that include reduced oxygen and bioreactors. Under these conditions, the cells secrete soluble proteins that include both growth factors and soluble precursors to the deposited extracellular matrix. Several of these proteins are known to be important in the control of the hair cycle and will stimulate resting hair follicles to resume hair formation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, ages 21-65 years.
- •A healthy scalp with no cutaneous disorder.
- •Subject should be in good general health.
- •Male subjects must be classified 3 Vertex, 4, 4A (if large enough), 5, 5A, or 6 under the Norwood-Hamilton Classification for Male Pattern Hair Loss (See Appendix 1).
- •Subject must be Fitzpatrick Type I, II, III and IV skin pigmentation (See Appendix 2). Type IV is acceptable however Type I-III is preferable.
- •Willing and able to comply with scheduled visits (Total: 7 visits in 48 weeks)
- •Willing to maintain the same hair style during the study period.
- •Willing to have a total of four microscopic dot tattoos. Two tattoos per treatment site (one in the center and one on the edge) of the two target regions of the scalp at miniaturization zone.
- •Willing to have 2 cm2 hairs clipped at treatment areas.
- •Willing to forgo the use of scalp products, including dye, throughout the study except for study related dye.
- •Willing to use a mild, a non-ionic shampoo throughout the course of the study.
排除标准
- •History of keloid formation or hyperpigmentation.
- •A history of any acute or chronic illness that in the opinion of the investigators might confound the results of the study including some drugs or medications.
- •Active skin diseases (e.g. eczema, atopic dermatitis, psoriasis, skin cancer, sun damaged skin with actinic keratosis on scalp, etc.).
- •Routine high dosage use of anti-inflammatory medications (aspirin, ibuprofen, corticosteroids), immunosuppressive drugs or antihistamine medications (steroid nose drops and/or eye drops are permitted). Two 81 mg or one 325 mg aspirin per day is also acceptable.
- •Use of topical drugs or other cosmetics on the scalp.
- •Immunological disorders such as HIV positive, alopecia areata, and systemic lupus erythematosus.
- •Participation in any clinical study within the last four weeks.
- •Moderate or severe seborrheic dermatitis of scalp.
- •Damaged skin in or around test sites including sunburn, uneven skin tones, tattoos, scars or other disfiguration of the test site.
- •Use of OTC (over-the-counter) or prescriptive topical or hair treatments, as well as hair transplantation surgery during the last 6 months. This includes Minoxidil 2% or 5% and/or Finasteride 1mg or any 5alpha-reductase inhibitors.
- •Currently using hair system or wig.
- •Presence of hair transplants or scalp surgery.
- •History of allergy or intolerance to lidocaine and/or epinephrine.
- •Use of hair dye (not study related) during the study duration.
- •Any condition for which the Investigator determines that the subject could be placed under undue risk.
- •Reported history of allergy or intolerance to bovine proteins.
结局指标
主要结局
Systemic safety measures will be assessed by measuring vital signs, adverse experiences, laboratory tests (hematology, clinical chemistry and urinalysis)and immunological response (anti-drug antibodies)
时间窗: Clinically significant change from screening visit to Week 12
Non-vellus hair counts
时间窗: Change from Baseline to week 12 in treatment areas
次要结局
- Hair Thickness Density(Change from Baseline to week 48 in treatment areas)
- Local safety measures will be assessed by clinical exam of treatment areas and monitoring adverse events(Clinically significant change from Screening visit to Week 48)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Retrospective Study on the Safety and Therapeutic/Improvement Effects of Intravenous Administration of SHED-CM for ALS (SHED-CAH2023)Amyotrophic Lateral SclerosisNCT06608719Hitonowa Medical24
已完成
1 期
Does Hyaluronic Acid Affect Periodontal Treatment?PeriodontitisNCT03754010Yuzuncu Yıl University24
终止
4 期
Different Dosage Regimens of Methocarbamol/Paracetamol in Acute Non-specific Low Back Pain. MioPain StudyLow Back PainNCT05204667Aziende Chimiche Riunite Angelini Francesco S.p.A172
已完成
不适用
Clinical study on the efficacy and safety of cultured (human) autologous hair follicle dermal sheath cup cells (DSCC) on androgenetic alopecia.Androgenetic alopeciaJPRN-UMIN000023343Tokyo Medical University Hospital67
招募中
4 期
Efficacy and Safety of Topical Hydrocortisone on Signs and Symptoms of Dry Eye Associated to Meibomian Gland DysfunctionDry EyeMeibomian Gland DysfunctionNCT05159284Laboratorios Thea, Spain54