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Effect Of Glaze 5-In-1 Acne Control gel to treat ACNE(pimples).

A Prospective, Single Arm, Clinical Study To Evaluate The Efficacy And Safety Of Glaze 5-In-1 Acne Control Formula In Patients With Acne Vulgaris - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/058098
Enrollment
30
Registered
2023-09-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Health Condition 1: L700- Acne vulgaris

Interventions

Intervention1: GLAZE 5-IN-1 ACNE CONTROL FORMULA: To be Applied topically morning and night by taking adequate amount to cover the lesion . For 4 weeks. Control Intervention1: Not Applicable: Not App

Sponsors

Pontika Aerotech Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy male or female subjects in the age group of 18-45 years 2. Healthy skin in the test areas; 3. Subjects willing and capable to follow the study rules and a fixed schedule; 4. Ability of giving consent for participation in the study; 5. Subjects with good health in general and good mental condition; 6. Subjects who present at least 10 inflammatory lesions; 7. Oily skin on the face

Exclusion criteria

Exclusion criteria: 1. Pregnancy or breastfeeding; 2. Subjects who present severe acne; 3. Subjects who present more than two nodular lesions; 4. Subjects who changed their oral contraception method up to three months before the study beginning; 5. Subjects who did acne hormonal treatment less than 6 months before the study; 6. Subjects who did oral isotretinoïne treatment less than 1 month before the study; 7. Subjects who did topical acne treatment less than 90 months before the study; 8. Subjects who did aesthetic treatment less than 6 months before the study (like laser and peeling); 9. Subjects who did treatment with antibiotics within the last 4 months; 10. Simultaneous participation in different studies from external research institutes on the same test sites 11. Hypersensitivity to any of the ingredients of the test product. 12. Pregnant or lactating women 13. Patients on steroid therapy or any other immunomodulatory agents

Design outcomes

Primary

MeasureTime frame
1) Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5- point Global Acne Assessment Score (GAAS) 2)Change From Baseline in Inflammatory Facial Lesion Counts 3)Change From Baseline in Noninflammatory Facial Lesion Counts 4) From Baseline in Total Lesion Counts 5)Microbiological Swab from the Acne lesion site will be taken 6)Instrumental Assessment: -Sebumetric analysis (Baseline, 1Hr, 2Hr, 6Hr, 12Hr and 24Hrs post application) and also post study at day 30. - Corneometer analysis for skin Moisturization (Baseline, 1Hr, 2Hr, 6Hr, 12Hr and 24Hrs post application) 7) Dermatology Life Quality Index (DLQI) questionnaire Timepoint: Day 0, 15 and 30

Secondary

MeasureTime frame
Patient and Investigator Feedbacks will be obtained Adverse event monitoringTimepoint: BAseline, Day 0, Day 15,Day 30

Countries

India

Contacts

Public ContactDr Gayathri Sivakumar

Thirumalai medical Centre, ki3

saheerose@gmail.com9443627722

Outcome results

None listed

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