Evaluating Ayurvedic Antiseptic Products Boroline Suthol Antiseptic Neem, Boroline Suthol Antiseptic Neem gel for Facial Acne.

Phase 4

Completed

• Conditions: Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue

• Registration Number: CTRI/2023/10/058690
• Lead Sponsor: GD Pharmaceuticals Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. Healthy males & female subjects in the age group of 13-45 years (both age inclusive)

2. Subject has a valid proof of identity and age.

3. Subject has apparently healthy skin on the test area.

4. Subjects must have a facial acne score of 1.5 to 3.5 that will be clinically determined to be mild to moderate.

5. Subjects having 5-30 non-inflammatory and 5-20 inflammatory active lesions. No treatment for acne/facial in the past 1 month.

6. Subjects representing normal, oily, dry, and combination skin.

7. Subjects willing to give voluntary written informed consent.

8. Subjects willing to come for regular follow-up visits.

9. Subjects ready to follow instructions during the study period.

10. Subjects without any open wounds, cuts, abrasions, irritation symptoms on the test area.

11. Subject willing to perform UPT (for females only).

Exclusion Criteria

1. Subjects with Known hypersensitivity to any of the study products or constituents.

2. Subjects having any significant pathology in the test area.

3.Dark spots and post-acne scars on the instrument measurement area.

4. Subjects with any kind of skin allergy, antecedents, or cutaneous disease which may influence the study results.

5. Subjects having topical or systemic treatment in the last month prior to participation in the study and during the study that could interfere with the study treatments/assessments.

6. Subject is Pregnant or Lactating.

7. Subject with any significant medical condition that would interfere with the participation in the trial.

8. Subjects participated in any other cosmetic or therapeutic trial or in a similar investigation.

9. Subject is having Scars, excessive terminal hair, or tattoos on the test area.

10. Any antifungal or antibiotic use 14 days prior to enrolment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified