A Phase 3, Open-Label, Randomised, Multi-Arm, Single-Centered Clinical Study To Evaluate The Safety, Tolerability, And Efficacy Of Ethniq Skin Revive.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1.Change in PASI score at day 90 compared to baseline.
研究概览
简要总结
Efficacy Findings:
Psoriasis Arm:
* The mean PASI score decreased significantly from a baseline value of 32.88 (±7.76) to
4.204 (±1.2) at Day 90, representing a mean reduction of 28.676 points (p < 0.001).
* The Physician’s Global Assessment (PGA) improved from an average baseline score of
approximately 3.78–4 (indicative of moderate to severe disease) to around 0.28–0 at Day
90 (indicative of minimal to cleared disease).
* These improvements are consistent with a clinically meaningful reduction in disease
severity.
Fungal Infections Arm:
* Considering that subjects achieving either complete absence (coded as 1) or mild (coded
as 2) symptoms are classified as “cured,” the clinical cure rate improved from 8% at
baseline to 98% at Day 90 (p < 0.05), indicating a marked improvement in the resolution of
fungal infection signs and symptoms.
Alopecia Areata Arm:
* The mean SALT score decreased significantly from 41.012 (±2.36) at baseline to 12.89
(±1.6) at Day 90 (p < 0.05), demonstrating effective hair regrowth as corroborated by
photographic assessments.
Dry Eczema Arm:
* Symptom severity scores decreased from a mean of 2.53 (on a 0–3 scale) at baseline to
1.2 at Day 90, while skin hydration scores improved significantly (p < 0.001), indicating
both symptomatic relief and improved skin barrier function.
Patient-Reported Outcomes:
Patient-reported measures showed consistent improvements across all arms. Quality of Life (QoL)
responses, as well as assessments of emotional well-being and treatment satisfaction, indicated
that a higher percentage of subjects reported improved daily functioning and reduced stress by
Day 90. These improvements reinforce the clinical findings and suggest that the benefits of Ethniq Skin Revive extend beyond objective clinical endpoints.
Safety Profile:
The safety analysis revealed that Ethniq Skin Revive was well tolerated. No serious adverse
events were reported, and the overall incidence of adverse events was minimal. Vital signs
remained stable throughout the study, and treatment compliance was 100% across all arms.
These safety findings are critical in supporting the favourable risk–benefit profile of the treatment.
Overall Conclusions:
The data from this study provide robust evidence that Ethniq Skin Revive offers statistically
significant and clinically meaningful improvements in both objective clinical measures and patient- reported outcomes across all four treatment arms. The favourable safety profile further supports its use as an effective treatment option for psoriasis, superficial fungal infections, alopecia areata,
and dry eczema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female patients aged 18 and above with moderate to severe psoriasis (at least 25 percent Body Surface Area involvement excluding scalp, face, groin, axillae, and intertriginous areas).
- •2.Psoriasis Global Assessment (PGA) score of at least
- •3.Patients with superficial fungal infection.
- •4.Participants with alopecia areata with at least 30% scalp hair loss (SALT score ≥ 30).
- •5.Patients presenting symptoms of dry eczema such as swelling, pricking sensation, intense itching, swelling of the body with itching, fatigue, giddiness, emaciation, blabbering, fleshy odor.
- •6.Willingness to attend regular follow up visits.
- •7.Written informed consent.
- •8.Subjects who have not participated in a similar study in the last 4 weeks.
排除标准
- •1.History of adverse reactions to Cosyntropin or similar test reagents.
- •2.Psoriasis involving only the scalp, face, groin, axillae, and/or other intertriginous areas.
- •3.Current diagnosis of types of psoriasis other than stable plaque psoriasis.
- •4.History of psoriasis unresponsive to topical corticosteroid therapy.
- •5.Known history of androgenic alopecia or female pattern hair loss prior to alopecia areata.
- •6.Use of topical or systemic treatments that could interfere with psoriasis status or HPA axis function.
- •7.Other dermatological conditions that may interfere with the assessment of psoriasis.
结局指标
主要结局
1.Change in PASI score at day 90 compared to baseline.
时间窗: Day 1, Day 30, Day 60 and Day 90
Psoriasis
时间窗: Day 1, Day 30, Day 60 and Day 90
2.Change in PGA score at day 30, 60, 90 compared to baseline.
时间窗: Day 1, Day 30, Day 60 and Day 90
次要结局
- 1.Fungal Infections:Clinical cure rate at day 90 and mycological cure rate at day 30, 60, 90.(2.Alopecia Areata:Change in SALT score at day 90 compared to baseline and hair regrowth as assessed by photographic and investigator assessments at day 30, 60, 90.)
研究者
Dr Uday Kumar S
Dr. Uday’s Advance Skin and Hair clinic