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

A multicentric, double arm, open-label prospective clinical study to evaluate the efficacy & safety of the Investigational ayurvedic antiseptic products as Boroline Suthol Active Neem and Boroline Suthol Active Neem Gel in subjects having mild to moderate facial acne. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/058690
Enrollment
100
Registered
2023-10-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Boroline Suthol Active Neem: Product will be applied on the affected areas or facial acne prone areas for consecutively 30 days in a time gap of 8-12 hours. Study Duration 30 days Ther

Sponsors

GD Pharmaceuticals Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Secondary

MeasureTime frame
Effectiveness against AcneTimepoint: Day 0 Day 10 Day 20 Day 30

Primary

MeasureTime frame
1 Reduction in lesion 2 Reduction in pore size count 3 Improvement in skin texture 4 Skin brightness and overall appearance 5 Reduction in redness associated with acne 6 Reduction in size of inflammatory acne lesions 7 Improvement in existing comedones 8 Reduction in symptoms like burning itching stinging and tingling Timepoint: Day 0 Day 10 Day 20 Day 30

Countries

India

Contacts

Public ContactPurushotam Yadav

Auriga Research Private Limited

ct@aurigaresearch.com7889161551

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026