A Study to Test the Safety and Effects of Ethniq Skin Revive in Patients with Different Skin Problems.

A Phase 3, Open-Label, Randomised, Multi-Arm, Single-Centered Clinical Study To Evaluate The Safety, Tolerability, And Efficacy Of Ethniq Skin Revive. - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075477

Enrollment

200

Registered

2024-10-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

Health Condition 1: B49- Unspecified mycosis Health Condition 2: L409- Psoriasis, unspecified Health Condition 3: L639- Alopecia areata, unspecified Health Condition 4: L309- Dermatitis, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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. 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Psoriasis 1.Change in PASI score at day 90 compared to baseline. 2.Change in PGA score at day 30, 60, 90 compared to baseline. Timepoint: Day 1, Day 30, Day 60 and Day 90	—

Secondary

Measure	Time frame
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. 3.Dry Eczema:Change in severity of symptoms score from baseline to day 90 and improvement in skin hydration and barrier function at day 30, 60, 90. Timepoint: Day 1, Day 30, Day 60 and Day 90	—

Measure

Time frame

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. 3.Dry Eczema:Change in severity of symptoms score from baseline to day 90 and improvement in skin hydration and barrier function at day 30, 60, 90. Timepoint: Day 1, Day 30, Day 60 and Day 90

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Countries

India

Contacts

Public ContactMs Arpita Malgi

Samahitha Research Solutions

satyalm@samahitha.com9739001749

Outcome results