Health Condition 1: L089- Local infection of the skin and subcutaneous tissue, unspecified
Conditions
Interventions
None listed
Sponsors
Surabhi Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 to 65 years at the time of enrollment. 2. Presence of minor open wounds or superficial skin infections, as clinically assessed by the Investigator. 3. Participants who are willing to avoid the use of other topical antiseptics, antibiotics, antifungals, or medicated products on the affected area during the study period. 4. Participants who are willing and able to provide written informed consent. 5. Participants who are willing to comply with the study requirements, including completing all scheduled visits and questionnaires.
Exclusion criteria
Exclusion criteria: 1. Presence of severe or chronic wounds, including but not limited to diabetic ulcers, burns, pressure ulcers, or surgical wounds requiring systemic therapy. 2. Presence of severe skin conditions requiring systemic treatment. 3. Participants with uncontrolled systemic illnesses that may interfere with study participation or interpretation of results (e.g., uncontrolled diabetes, autoimmune diseases). 4. History or evidence of HIV, Hepatitis B, Hepatitis C, or active/latent tuberculosis infection. 5. Known hypersensitivity or allergy to any ingredient of the investigational product. Use of systemic antibiotics, corticosteroids, or immunosuppressive therapy for wound or skin infection management within 14 days prior to screening. 6. Participation in another clinical trial within 3 months prior to screening. 7. History of drug or alcohol abuse or addiction within the past 5 years. 8. Uncontrolled hypertension or any other clinically significant condition that, in the Investigator s opinion, may make the participant unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Wound Healing and Infection Status: 1. Change in Investigator s Global Assessment (IGA) score from Baseline (Day 0) to End of Treatment (Day 30). 2. Assesses improvement in overall wound healing and reduction in clinical signs of infection, including redness, discharge, swelling, and pain/tenderness.Timepoint: Baseline (Day 0) Visit 2 (Day 15 2 days) EOS (Day 30 2 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Overall Wound Condition: a. Change in standardized clinical wound assessment parameters from Baseline to Day 15 and Day 30, including wound size, appearance, exudate, erythema, swelling, pain, and evidence of granulation tissue and epithelialization. b. Evaluates the progression of wound healing during the study period. Timepoint: Baseline (Day 0) Visit 2 (Day 15 2 days) EOS (Day 30 2 days);2. Change in Health-Related Quality of Life: c. Change in EQ-5D-5L questionnaire score from Baseline to Day 30. d. Measures participant-reported impact of wound condition on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Timepoint: Baseline (Day 0) Visit 2 (Day 15 2 days) EOS (Day 30 2 days);3. Safety and Tolerability a. Incidence, type, severity, and causality of Adverse Events (AEs) throughout the study. b. Any serious adverse events (SAEs) reported throughout the study period. c. Incidence and grading of local application-site reactions, including redness, irritation, itching, burning sensation, pain, or worsening of wound condition. a. Investigator s safety/tolerability assessment at each study visit.Timepoint: Baseline (Day 0) Visit 2 (Day 15 2 days) EOS (Day 30 2 days) | — |
Countries
India
Contacts
Public ContactMs Mamatha B Gokavi
Samahitha Research Solutions
Outcome results
None listed