EFFICACY AND TOLERABILITY OF MICRONEEDLING ASSISTED TOPICAL O.O25% DUTASTERIDE LOTION MESOTHERAPY IN COMPARISION WITH MICRONEEDLING ALONE FOR TREATMENT OF ANDROGENETIC ALOPECIA IN MALES ON 5% MINOXIDIL LOTION-A randomised clinical study
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- increase in hair density from baseline to 6 months
研究概览
简要总结
Androgenetic alopecia (AGA), commonly known as male pattern baldness, is one of the most prevalent forms of hair loss affecting a significant proportion of males, particularly those over the age of 30. This condition can have a profound impact on a person’s self-esteem, social interactions, and overall quality of life. Despite the availability of treatment options such as minoxidil and finasteride, these therapies have limitations in terms of efficacy, side effects, and long-term sustainability.
Microneedling, a procedure involving the use of small needles to create controlled micro-injuries to the scalp, has gained attention as an effective treatment for AGA by promoting hair regrowth through collagen induction and enhancing the absorption of topical treatments. It has shown promise in improving hair density, regrowth, and scalp health when used either alone or in combination with other therapeutic agents.
On the other hand, dutasteride, a 5-alpha-reductase inhibitor, has proven effectiveness in the treatment of AGA by inhibiting the conversion of testosterone to dihydrotestosterone (DHT), a hormone responsible for hair follicle miniaturization in AGA. While dutasteride is primarily used in oral form, recent studies suggest that topical applications of dutasteride may provide the same benefits with reduced systemic side effects, making it an appealing option for localized treatment.
Despite promising individual results with M****icroneedling and Application of Topical dutasteride, there is limited research on their combined use for treating AGA. Combining microneedling with dutasteride could theoretically amplify the beneficial effects of both treatments by increasing the absorption of dutasteride through the micro-channels created during the microneedling process and enhancing the regenerative effects of the treatment. This combination approach may also mitigate the limitations of each individual therapy, offering a safer and more effective alternative for patients with moderate to severe AGA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Age: Males aged 18 to 50 years.
- •2.Diagnosis of Androgenetic Alopecia: Male participants diagnosed with moderate to severe androgenetic alopecia (Norwood-Hamilton Grades 2-5).
- •Have given written consent before any treatment is commenced.
排除标准
- •1.Hypersensitivity to Dutasteride or Other 5-Alpha-Reductase Inhibitors: Participants with a known allergy or sensitivity to dutasteride or other similar medications (e.g., finasteride)..
- •2.Patient having keloid scaring or keloidal tendency.
- •3.History of bleeding disorder and anticoagulant therapy.
- •4.Oral steroid therapy.
- •5.Active skin infection like warts, herpes and bacterial infection.
- •6.Patient on any other systemic drugs therapy which in the judgement of investigator may interfere with interpretation of results.
- •7.Patients having any other inflammatory conditions of the scalp.
- •8.Hair loss due to any other etiology- malignancy or systemic illnesses.
- •Patients with known hypersensitivity to topical anaesthetic agents.
结局指标
主要结局
increase in hair density from baseline to 6 months
时间窗: increase in hair density from baseline to 6 months | increase in hair thickness from base line to 6 months
increase in hair thickness from base line to 6 months
时间窗: increase in hair density from baseline to 6 months | increase in hair thickness from base line to 6 months
次要结局
- Hair Growth Rate: Change in hair growth rate (mm/month) from baseline to 6 months.(2. Anagen/Telogen Ratio: Change in anagen/telogen ratio from baseline to 6 months.)
研究者
Balkrishna Nikam
krishna vishwavidyapeeth karad