Checking if RSO Plus Oil is Safe and Works for People with skin infection

An Open-Label, Single-Arm, Single-Center, Phase III Clinical Study to Evaluate the Safety and Efficacy of RSO Plus oil in Subjects with Cellulitis - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097125

Enrollment

Registered

2025-11-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: L039- Cellulitis and acute lymphangitis,unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female participants aged 18 50 years. 2. Clinically diagnosed cellulitis of mild-to-moderate severity (as per investigator s judgment). 3. No active dermatologic conditions or recent skin infections in the treatment area that could interfere with topical application. 4. Stable general health without chronic medical conditions requiring systemic therapy during the study period. 5. Willing and able to provide written informed consent prior to any study-related procedures. 6. Willing to comply with study requirements, including scheduled visits, questionnaires, and use of the investigational product as instructed.

Exclusion criteria

Exclusion criteria: 1. History of skin allergy, eczema, or hypersensitivity in the treatment area. 2. Pregnant or breastfeeding women, or those planning pregnancy during the study period. 3. Known allergy or intolerance to any component of RSO Plus Oil. 4. Presence of severe cellulitis requiring immediate systemic antibiotic therapy or hospitalization. 5. Participation in another clinical study or use of investigational drugs within the last 30 days prior to screening. 6. Current use of other topical medicated/herbal treatments on the affected area. 7. Any condition that, in the opinion of the investigator, may compromise subject safety, compliance, or study integrity.

Design outcomes

Primary

Measure	Time frame
1. Change in incidence and severity of cellulitis symptoms (erythema, skin irritation, burning sensation, hypersensitivity) from baseline to Day 20 and Day 40. -Assessment tools: a. Physician s global assessment (clinical grading scale: none, mild, moderate, severe). b. Patient-reported symptom severity using Visual Analog Scale (VAS; 0 10 cm). -Endpoint definition: Mean change in composite symptom scores compared to baseline.Timepoint: Screening / Baseline (Day 0) Visit 2 (Day 20 2) Visit 3 (Day 40 2; EOS)	—

Measure

Time frame

1. Change in incidence and severity of cellulitis symptoms (erythema, skin irritation, burning sensation, hypersensitivity) from baseline to Day 20 and Day 40. -Assessment tools: a. Physician s global assessment (clinical grading scale: none, mild, moderate, severe). b. Patient-reported symptom severity using Visual Analog Scale (VAS; 0 10 cm). -Endpoint definition: Mean change in composite symptom scores compared to baseline.Timepoint: Screening / Baseline (Day 0) Visit 2 (Day 20 2) Visit 3 (Day 40 2; EOS)

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Secondary

Measure	Time frame
1. Improvement in cellulite grade & skin firmness/texture - Measured using the Cellulite Severity Scale (CSS), a validated 5-item scale (range 0 15). - Evaluated at baseline, Day 20, & Day 40. 2. Improvement in quality of life (QoL) - Assessed using the Dermatology Life Quality Index (DLQI) or equivalent validated dermatology-specific questionnaire. - Mean change from baseline to Day 20 & Day 40. 3. Subject satisfaction & cosmetic acceptability - Measured through a structured questionnaire rating texture, smoothness, fragrance, & overall product satisfaction (5-point Likert scale). 4. Safety & tolerability - Incidence, severity, & causality of adverse events (AEs) & adverse drug reactions (ADRs). - Changes in vital signs (Baseline & Day 40).Timepoint: Screening / Baseline (Day 0) Visit 2 (Day 20 2) Visit 3 (Day 40 2; EOS)	—

Measure

Time frame

1. Improvement in cellulite grade & skin firmness/texture - Measured using the Cellulite Severity Scale (CSS), a validated 5-item scale (range 0 15). - Evaluated at baseline, Day 20, & Day 40. 2. Improvement in quality of life (QoL) - Assessed using the Dermatology Life Quality Index (DLQI) or equivalent validated dermatology-specific questionnaire. - Mean change from baseline to Day 20 & Day 40. 3. Subject satisfaction & cosmetic acceptability - Measured through a structured questionnaire rating texture, smoothness, fragrance, & overall product satisfaction (5-point Likert scale). 4. Safety & tolerability - Incidence, severity, & causality of adverse events (AEs) & adverse drug reactions (ADRs). - Changes in vital signs (Baseline & Day 40).Timepoint: Screening / Baseline (Day 0) Visit 2 (Day 20 2) Visit 3 (Day 40 2; EOS)

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Countries

India

Contacts

Public ContactMs Arpita Malgi

Samahitha Research Solutions

satyalm@samahitha.com09739001749

Outcome results