None listed
Conditions
Interventions
Intervention1: Hexilak acne scar serum: Once or Twice daily as directed by Investigator for 90 days
Sponsors
Menarini India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Healthy participants of either gender from 18-45 years of age after assessing medical history, physical examination and clinical judgment of the investigator. 2) Participants are diagnosed clinically with acne scars with or without hyperpigmentation. 3) Participants who have not undergone any scar treatment in the past 6 months. 4) Willing to refrain from use of all other topical medications as per Investigator discretion, that will significantly affect the study results. the use of other cosmetic products on face during the course of the study. 5) Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures. 6) Having signed a Consent Form, after being informed orally and in writing of all information concerning the study procedures and study objectives.
Exclusion criteria
Exclusion criteria: 1) Pregnant women or lactating women. 2) Participants with a history of allergic dermatitis or contact allergy to cosmetics, with known sensitivity to any of the ingredients in the study product. 3) Presence of any other skin conditions, diseases, or medical conditions in the investigators opinion might require concurrent therapy and interfere with the evaluation of the study medication or compromise patients safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate percentage of subjects showing improvement in acne scars on Physician Global Aesthetic Improvement ScaleTimepoint: Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects showing improvement in acne scars on Physician Global Aesthetic Improvement Scale.Timepoint: Day 30;Mean change in Physician Global Aesthetic Improvement Scale at all follow up of treatment visits.Timepoint: Day 30, Day 60, and Day 90;Percentage of subjects showing improvement in acne scars on Subject Global Aesthetic Improvement Scale at all follow up of treatment visits.Timepoint: Day 30, Day 60, and Day 90;Mean change in Subject Global Aesthetic Improvement Scale at all follow up of treatment visits.Timepoint: Day 30, Day 60, and Day 90;Mean change in Post Acne Hyperpigmentation Index as compared to baseline.Timepoint: Day 1, Day 30, Day 60, and Day 90;Percentage of subjects on Subject satisfaction score.Timepoint: Day 30, Day 60, and Day 90 | — |
Countries
India
Contacts
Public ContactDr TD Rajan
Dr. T. D. Rajans Clinic
Outcome results
None listed