Health Condition 1: L700- Acne vulgaris
Conditions
Interventions
None listed
Sponsors
Hapdco Lifesciences
Eligibility
Inclusion criteria
Inclusion criteria: Participants will be eligible to participate if they nEet all of the following criteria: - Adults of either gender, aged 18 to 55 years at the time of enrollment. - No use of anti-acne treatnEnts (topical or systemic) within 1 month prior to screening. - Participants with normal to oily (greasy) skin types. - Participants willing to provide written informed consent and comply with study procedures and visit schedule.
Exclusion criteria
Exclusion criteria: Participants will be excluded if they nEet any of the following criteria: - Pregnant, lactating, or planning to become pregnant during the study period. - Participation in another clinical trial within the last 30 days prior to enrollnEnt. - Presence of active skin disease (e.g., eczema, psoriasis, dermatitis, infection) in the test area (face). - Participants with sensitive skin prone to irritation or reactions. - History of allergic or contact dermatitis. - Currently undergoing treatment for any skin condition on the face or body. - Known hypersensitivity or allergic reaction to any component of investigational product. - Presence of open wounds, cuts, or broken skin at the application site. - Presence of any uncontrolled systemic illness or significant psychiatric disorder that, in the opinion of the Investigator, may interfere with study participation, safety, or evaluation of study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction in Acne Severity IGA Score 1. Definition Evaluation of improvement in Acne Vulgaris severity 2. Assessment Method Acne severity will be assessed using the Investigators Global Assessment IGA scale ranging from 0 Clear to 4 Severe 3. Time Points Baseline Day 0 and Day 90 plus or minus 2 days 4. Endpoint Measure Mean change in IGA score from Baseline to Day 90 2. Change in Systemic Inflammation hs CRP Levels 1. Definition Evaluation of change in systemic inflammatory status 2. Assessment Method Serum high sensitivity C reactive protein hs CRP levels will be measured using standard laboratory methods 3. Time Points Baseline Day 0 and Day 90 plus or minus 2 days 4. Endpoint Measure Mean change in hs CRP levels from Baseline to Day 90 Timepoint: Screening & Baseline (Day 0) Follow-up (Day 30 2 days) Follow-up (Day 60 2 days) End of Study(Day 90 2 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of Life Assessment 1. Definition Evaluation of the effect of Aqui Plus Cream on participants quality of life 2. Assessment Method Using the Acne QoL questionnaire to assess emotional well being self perception social functioning and acne related symptoms 3. Time Points Baseline Day 0 and Day 90 plus or minus 2 days 4. Endpoint Measure Change in Acne QoL scores from Baseline to Day 90 2. Safety and Tolerability 1. Definition Evaluation of safety and tolerability during the study period 2. Assessment Method Monitoring adverse events vital signs and physical examination findings 3. Time Points All study visits 4. Endpoint Measure Incidence severity and relationship of adverse events and clinically significant changes in vital signs and physical examination findings during the study period Timepoint: Screening & Baseline (Day 0) Follow-up (Day 30 2 days) Follow-up (Day 60 2 days) End of Study(Day 90 2 days) | — |
Countries
India
Contacts
Public ContactMamatha B Gokavi
Hapdco Lifesciences
Outcome results
None listed