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Process Standardization in Skin Health: Assessing Wound Creation Methods and Effectiveness of Test Treatments in Wound-healing.

Process Validation in Dermatology: Assessing Wound Creation Methods and Treatment Efficacy - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/05/067560
Enrollment
5
Registered
2024-05-17
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

None listed

Interventions

Intervention1: NIL: NIL Intervention2: Test Product B: Topical Moisturizing Cream (10%) Intervention3: Test Product C: Parachute Coconut Oil Control Intervention1: NIL: NIL

Sponsors

NovoBliss Research Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 55 years (both inclusive). 2. Good general health as determined from recent medical history. 3. No previous history of adverse skin conditions, and not under any medication likely to interfere with the results.

Exclusion criteria

Exclusion criteria: Subjects were not included if they had a history of allergies or specific allergic reactions upon using dermatological/cosmetic products.

Design outcomes

Primary

MeasureTime frame
1. Trans Epidermal Water Loss Measurement - To assess the ability of skin to retain water and evaluate the impact of treatments on skin barrier function using Tewameter TM Hex. 2. Skin Hydration Levels by Corneometer CM 825 - To measure the hydration status of the skin and determine the moisturizing effects of the treatments. 3. Skin Surface Topography by Visioscan VC 20plus - Analysis of skin surface characteristics, including smoothness, scaliness, roughness, and wrinkles, to understand the overall skin texture and appearance.Timepoint: 1. Visit 01 (Day -02) 2. Visit 02 (Day -01) 3. Visit 03 (Day 01) 4. Visit 04 (Day 02, 24 hours post-dose) 5. Visit 05 (Day 05) 6. Visit 06 (Day 08) 7. Visit 07 (Day 28, End of Study Visit)—

Secondary

MeasureTime frame
Photographic Documentation: To visually capture changes in the appearance of the skin at each stage and time-point, providing a comprehensive record for analysis.Timepoint: 1. Visit 01 (Day -02) 2. Visit 02 (Day -01) 3. Visit 03 (Day 01) 4. Visit 04 (Day 02, 24 hours post-dose) 5. Visit 05 (Day 05) 6. Visit 06 (Day 08) 7. Visit 07 (Day 28, End of Study Visit);Visual Assessment using Draize Scale: A standardized scale for visually grading skin irritation and assessing the overall skin condition.Timepoint: 1. Visit 01 (Day -02) 2. Visit 02 (Day -01) 3. Visit 03 (Day 01) 4. Visit 04 (Day 02, 24 hours post-dose) 5. Visit 05 (Day 05) 6. Visit 06 (Day 08) 7. Visit 07 (Day 28, End of Study Visit)—

Countries

India

Contacts

Public ContactDr Nayan Patel

NovoBliss Research Private Limited

dr.nayan@novobliss.in09909013286

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026