Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: GUGGULCERA: The investigational product is a herbal formulation of Commiphora wightii (guggul) and Amorphophallus konjac extracts. The formulation 100 % natural formulation with charac
Sponsors
Vidya Herbs Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male or female aged 18 â?? 40 years of age both inclusive in general good health Must have a definite clinical diagnosis of mild to severe acne vulgaris Grade 2 Grade 3 or Grade 4 on the Investigators Global Assessment IGA of acne severity 1 Must be willing and able to give informed consent and comply with the study procedures Female patients of childbearing potential must have been using accepted methods of birth control or must agree to continue to practice abstinence from 30 days prior to study entry to 30 days after the last administration of study drug
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 |
|---|---|
| Assess the Effectiveness and Safety of GUGGULCERA in the Treatment of Mild to Severe Acne Vulgaris and overall skin healthTimepoint: Proportion of subjects in each treatment group achieving success at Week 12, with success defined as IGA score of clear or almost clear and at least a one-point reduction in IGA score compared to Baseline. Mean percentage change in total acne, inflammatory and non-inflammatory lesion count from baseline to end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of the treatment arm in comparison with placebo on the â??The Cardiff acne disability indexâ?? To assess the safety and tolerability of the test product. To assess the effect of the treatment arm in comparison with placebo through following scale and questionnaire: Allergan Fine Line Scale Allergan Skin Roughness Scale Felix Von Lushan Skin Color Chart Modified Fitzpatrick Wrinkle Scale Skin Hydration Scale Patient Satisfaction Questionnaire Timepoint: Change in scores on the Cardiff Acne Disability Index scoring from baseline to end of the study Change in scores on following scale and questionnaire from Baseline to End of Study Allergan Fine Line Scale Allergan Skin Roughness Scale Felix Von Lushan Skin Color Chart Modified Fitzpatrick Wrinkle Scale Skin Hydration Scale Patient Satisfaction Questionnaire Change in laboratory parameters (safety) from baseline to end of the study | — |
Countries
India
Contacts
Public ContactDivya C
Bioagile Therapeutics Pvt. Ltd
Outcome results
None listed