None listed
Conditions
Interventions
None listed
Sponsors
MS Vee Herbal Care Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1)Male/females of = 18 years of age at the time of consent 2)Patient / Legally Acceptable Representative who can and willing to provide Informed Consent 3)Facial redness associated with rosacea with or without bumps or blemishes 4)Facial redness (IGA-R) score of 2 or 3 (i.e., mild or moderate) 5)IGA score of 2 or 3 (i.e., mild or moderate). 6)Willing to forego any other topical or non-topical treatment on the study areas during treatment (other than sun protection or the study specified face wash and moisturizer) 7)Willing to use the provided skincare regimen (e.g., face wash and moisturizer) over the duration of the study 8)Absence of any skin conditions that could interfere with the visual erythema assessments 9)Subjects who are willing to be photographed and video-recorded during study visits and willing to sign photographic release forms
Exclusion criteria
Exclusion criteria: 1)Known hypersensitivity or previous allergic reaction to any constituent of the Investigational Products (i.e., essential oils, fragrance, choline, phosphatidylcholine, etc.) 2)History or presence of a skin condition/disease that is located in the treatment area(s) and might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, psoriasis, significant actinic damage, vitiligo, open wounds, infection, etc.) 3)Uncontrolled systemic disease 4)Any transient flushing syndrome. 5)History of basal cell carcinoma within 6 months of Visit 1 6)Foreseen unprotected and intense/excessive UV exposure during the course of the study 7)Use of any of the following concomitant medications/procedures: a)Cosmetic and/or OTC products for redness reduction and/or skin clearing b)Topical medications for rosacea c)Systemic antibiotics or corticosteroids d)Topical antibiotics, corticosteroids, or antiparasitic agents e)Intense/excessive ultraviolet (UV) radiation f)Phototherapy, energy-based therapy, facials, chemical peels, microdermabrasion 8)Exposure to any other investigational drug/device within 30 days prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Change in Investigator Global Assessment (IGA) from baseline to end of the study. 5-point scale (0-Clear skin with no signs of bumps or blemishes,1-Almost clear, minimal lesions (less than 5 bumps or blemishes),2- Mild facial lesions (6-10 bumps or blemishes) 3 - Moderate lesions, marked redness (11-25 bumps or blemishes) 4 - Severe lesions, fiery redness (greater than 25 bumps or blemishes) 2)Change in Investigator Global Assessment of Redness (IGA-R) from baseline to end of the study 5-point scale (0-Clear skin with no signs of redness to 4-Severe, fiery redness) 3)Number of Treatment Emergent Adverse Event (TEAE) (serious or non-serious, expected or unexpected, related or non-related).(Time Frame From baseline up to EOS).Timepoint: 30 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Change in the number of acne lesions from baseline to end of the study. 2)Improvement in Post acne Hyper Pigmentation Index (PAHPI) severity scale score based on changes from baseline to end of the study. 3)Improvement in Global Acne Grading System (GAGS) score that gives a weight to each region (face and back) with a severity score (1–18, mild, 19–30,moderate,31–38, severe) 4)Assessment of skin tone improvement at End of study measured by visual analogue scale (VAS) score Timepoint: 30 Days | — |
Countries
India
Contacts
Public ContactDr MS Ramasamy
Sanjeev Biomedical Research Center
Outcome results
None listed