Clinical study on Anti-acne face pack in pimples

Evaluation of Efficacy and Safety of Anti-acne Face Pack in participants suffering from Acne Vulgaris- An open label, non-comparative, interventional, prospective, clinical study - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/07/044012

Enrollment

Registered

2022-07-14

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects suffering from acne vulgaris [mild and moderate as per Global Acne Grading System (GAGS)] as diagnosed by physician or dermatologist 2. Subjects willing to follow study instructions given by the investigator

Exclusion criteria

Exclusion criteria: 1. Subjects with known pre-existing systemic disease necessitating long-term medications. 2. Subjects with known current endocrinal disorders. 3. Subjects taking treatment for menstrual disorders 4. Subjects having systemic treatment for acne vulgaris. 5. Subjects on any other investigational products within 1 month prior to randomization; 6. Subjects with known current tuberculosis, HIV, ischemic heart disease, cancer, kidney failure. 7. Pregnant and lactating women 8. Known hypersensitivity to any of the ingredients of Anti-acne Face Pack 9. Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study

Design outcomes

Primary

Measure	Time frame
Changes in total number of inflammatory acne lesions on faceTimepoint: Screening / Baseline visit (Day 0), visit 1 (Day 15), visit 2 (Day 30), visit 3 (Day 45)	—

Secondary

Measure	Time frame
1. Changes in total numbers of non-inflammatory acne lesions 2. Changes in total lesion count (inflammatory and non-inflammatory) 3. Difference in number of comedones (blackheads and whiteheads) 4. Changes in severity of acne vulgaris 5. Changes in signs and symptoms of acne vulgaris 6. Changes in acne scarring 7. Changes in skin lightening effect 8. Changes in post acne dark spots 9. Global assessment for overall change by participants and by physician 10. Assessment of post treatment tolerability of study drug by participants and physician. 11. Assessment of adverse events/adverse drug reactions including vitals Timepoint: Screening / Baseline visit (Day 0), visit 1 (Day 15), visit 2 (Day 30), visit 3 (Day 45)	—

Measure

Time frame

1. Changes in total numbers of non-inflammatory acne lesions 2. Changes in total lesion count (inflammatory and non-inflammatory) 3. Difference in number of comedones (blackheads and whiteheads) 4. Changes in severity of acne vulgaris 5. Changes in signs and symptoms of acne vulgaris 6. Changes in acne scarring 7. Changes in skin lightening effect 8. Changes in post acne dark spots 9. Global assessment for overall change by participants and by physician 10. Assessment of post treatment tolerability of study drug by participants and physician. 11. Assessment of adverse events/adverse drug reactions including vitals Timepoint: Screening / Baseline visit (Day 0), visit 1 (Day 15), visit 2 (Day 30), visit 3 (Day 45)

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Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research Pvt. Ltd.

targetinstitute@yahoo.com9322522252

Outcome results