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

Phase 3

Completed

Conditions: Acne vulgaris,

Registration Number: CTRI/2023/09/058098

Lead Sponsor: Pontika Aerotech Limited

Brief Summary: Study Procedure:

The study who fulfilled the inclusion and exclusion criteria will be enrolled in the study . 30 Participants will be randomized in to a single group.

The application of the product will be done at site on each day of assessment throughout the study period by the subject. Subject will wash their test area with a water prior to the application. After pat dry, the test product will be applied on the acne lesions ( approximately 8-12 hours apart) twice daily throughout the study duration. After application, the subject should not wash their test site for at least 2 hours with water or any other product. Subjects will avoid unnecessary sun exposure immediately after morning product application. Take approx 1.0 gm quantity of test product on tip of index finger. Apply dot wise on whole face and then lightly spread test product using only fingers in outward direction. Ensure that you do not rub the product in to your skin. Apply the product twice daily in morning and evening on whole face for the period of 30 days

(As directed by the Dermatologist). Subject will be asked to visit Clinical Facility for their follow up at the end of 15 and 30 days and any other additional visits if needed.

Primary and secondary outcome

1) Global Acne Assessment Score (GAAS)

2) Change from baseline in Inflammatory facial Lesion counts

3) Change from Baseline in Noninflammatory Facial Lesions Counts

4) Microbiological swabs from Acne Lesion Site on baseline and Post study ( day 15 or day 30 based on healing)

5) Percentage of Patients Reporting Very Good or Excellent on Item 10 of the 5-Point Acne Symptom Impact Scale ( ASIS)

6) Overall Improvement of skin health

7) Scoring in terms of Itching

8) Instrument Analysis: Sebumetric Analysis, Corneometer Analysis

9) DLQI

10) Ease of use

11) Pre and Post study Photographic assessments

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

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

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 isotretinoÃ¯ne 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient and Investigator Feedbacks will be obtained	Adverse event monitoring

Trial Locations

Locations (1): Brindaâ€™s Skin Clinic
🇮🇳
Pondicherry, PONDICHERRY, India
Brindaâ€™s Skin Clinic
🇮🇳Pondicherry, PONDICHERRY, India
DrBrinda G David
Principal investigator
9751628254
docbrinz@gmail.com