None listed
Conditions
Interventions
Intervention1: Nixiyax: standard care of treatment plus Nixiyax 150mg orally in the night for 84 days
Control Intervention1: Standard care of treatment for acne vulgaris: oral standard care of treatme
Sponsors
Curatio Healthcare I Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Must have mild to severe acne Vulgaris 2. Must be willing and able to give informed Consent. 3.Female subjects Non Pregnant and Non lactating
Exclusion criteria
Exclusion criteria: 1 Known conditions that may interfere with the evaluation of acne vulgaris. Such conditions include but are not limited to the following: rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne or folliculitis; carcinoid syndrome; squamous cell carcinoma; mastocytosis; acneiform eruptions caused by make-up or medication; bacterial folliculitis; facial psoriasis; and facial eczema. 2 Subjects allergic to herbal products or any component of the study product 3 Subjects who have been treated topical or oral corticosteroids within 14 days prior to baseline 4 History of uncontrolled disease or immune deficient disorder 5 Any feature in the test areas (face) that according to the investigator may influence the results, for example, but not limited to moles, tattoos, scars, irritated skin, scratches, cuts and excess hair 6 Known HIV or Hepatitis B positive or any other immuno-compromised state 7 Female subjects who are pregnant, nursing or planning to become pregnant during study participation 8 Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 9 Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. changes in stress assessment questionnaire scores 2. Changes in Serum Cortisol LevelTimepoint: Day 0, Day 42, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| changes in 1. Acne lesion count 2. IGA acne severity 3. Dermatology Life Quality Index (DLQI) scoresTimepoint: Day 0. Day 42, Day 84 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Private Limited
Outcome results
None listed