A Single Centre, Open Label Study to Evaluate Effectiveness and Safety of Minoxidil 5 percentage + Finasteride 0.1 percentage Solution Fortified with 0.0033 percentage Melatonin (Tugain F plus) in Males with Pattern Hair Loss
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- Cipla Ltd
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage change in the proportion of anagen hair using frontal, temporal, and vertex trichoscopy in the treatment
研究概览
简要总结
Male pattern hair loss (MPHL) is the most common hair loss disorder in men, also known as androgenetic alopecia (AGA) due to the unclear link with androgens. It is characterized by progressive thinning in the central, frontal, and parietal scalp regions. It’s a non-scarring condition resulting from hair follicle miniaturization (Fabbrocini et al., 2018). Baldness affects both men and women, though it is more commonly seen in men. MPHL accounts for 58% of diffuse hair loss aged 30–50 years among Indian men (Mysore et al., 2019).
Etiology and Pathogenesis
MPHL is a multifactorial condition primarily influenced by genetic predisposition and hormonal factors. Its pathogenesis involves the action of androgens, particularly dihydrotestosterone (DHT), which induces hair follicle miniaturization and alters the hair growth cycle. A comprehensive understanding of MPHL requires exploring genetic determinants, hormonal impacts, and cellular mechanisms.
Genetic Factors
MPHL is highly heritable, with recent studies identifying 389 genomic regions associated with the condition. Key genes implicated in MPHL are those involved in androgen signaling and hair follicle development, underscoring the genetic basis of the disorder (Henne et al., 2023).
Hormonal Influence
Androgens play a pivotal role in MPHL, particularly in the miniaturization of hair follicles within the frontal and vertex regions of the scalp (P et al., 2024; Goodarzi et al., 2009). The condition typically manifests during puberty, with as many as 80% of men experiencing some degree of hair loss over their lifetime (Henne et al., 2023).
Cellular Mechanisms
At the cellular level, MPHL involves a dysregulation of the hair growth cycle, marked by a shortened anagen phase and a prolonged kenogen phase, leading to progressively thinner hair (Redmond et al., 2023). Emerging evidence also points to the role of microRNAs in hair follicle biology, highlighting their potential involvement in the condition’s pathophysiology (Goodarzi et al., 2010).
While genetic and hormonal factors remain central to MPHL, growing evidence suggests that environmental and lifestyle factors, including smoking and stress, may contribute to its progression (P et al., 2024). Understanding these multifactorial influences is essential for developing targeted therapeutic approaches.
Cipla Ltd has developed a medication Tugain F+ for controlling Androgenetic alopecia. The product consists of Minoxidil 5% + Finasteride 0.1% Solution Fortified with 0.0033% Melatonin. Currently, there are only two US Food and Drug Administration (FDA)-approved drugs for AGA: topical minoxidil and oral finasteride.
The combination of minoxidil and finasteride is well-supported by clinical evidence, the role of melatonin remains less established (Chandrashekar et al., 2015; Husanain et al., 2021; Fischer et al 2004). This study seeks to provide insights into effectiveness of combination minoxidil, finasteride with melatonin, outcome of the treatment and also documenting the safety profile of this combination.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male aged 18 to 49 years clinically diagnosed with androgenetic alopecia (male pattern hair loss).
- •2.Male subjects with Norwood-Hamilton grades II to V.
- •3.Subjects willing to follow and comply with the same hair-care regimen (including hair style, hair color and length) during the treatment period.
- •4.Willing to provide written informed consent for the trial.
排除标准
- •1.Known hypersensitivity to study treatment and its ingredients.
- •2.Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia.
- •3.Scalp hair loss on the treatment area, due to disease, injury, or medical therapy.
- •4.Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or a history of skin disease on the scalp that in the opinion of the investigator would interfere with the study assessments of effectiveness or safety.
- •5.Used hair weaving, hair extensions, texturizers, relaxers, occlusive wigs and non- study hair growth products (oral or topical) from prescription or over the counter /procedures within 30 days prior to screening.
- •6.Have received prior medications procedures within 30 days prior to screening.
- •7.History of current or suspected systemic or cutaneous malignancy and /or lymphoproliferative disease.
- •8.Evidence of tuberculosis infection or history of incompletely treated or untreated tuberculosis.
- •9.History of serious local infection (e.g., cellulitis, abscess) or systemic infection including but not limited to a history of treated infection (e.g., pneumonia, septicemia) within 3 months prior to screening.
- •Subjects on an antibiotic for a non-serious, acute local infection must complete the course prior to the enrolment into the study.
- •Any clinically significant medical or surgical history or laboratory investigations which in the opinion of the investigator may affect effectiveness analyses of study treatment or may impact the subject’s safety while participating in the study.
结局指标
主要结局
Percentage change in the proportion of anagen hair using frontal, temporal, and vertex trichoscopy in the treatment
时间窗: Baseline to 12 weeks of treatment
次要结局
- Percentage change in the proportion of general hair count, general hair density, anagen %, telogen %, terminal %, vellus %, mean hair thickness and total follicular units at frontal, temporal and vertex region using trichoscopy(Baseline to 12 weeks of treatment)
研究者
Dr B S Chandrashekar
CUTIS Academy of Cutaneous Sciences