Clinical Study to evaluate the safety and sfficacy of Nixoderm Tin in treating acne vulgaris in adults.

Recruiting

• Conditions: Acne vulgaris,

• Registration Number: CTRI/2025/05/087032
• Lead Sponsor: M/s.SC Johnson & Son Nigeria Ltd

Brief Summary

Acne vulgaris is a common cutaneous inflammatory disorder of the pilosebaceous unit, which runs a chronic course. The condition commonly manifests with papules, pustules, or nodules primarily on the face, although it can also affect the upper arms, trunk, and back. The pathogenesis of acne vulgaris involves the interaction of multiple factors that ultimately lead to the formation of its primary lesion, which is known as "comedo". Although acne vulgaris is commonly observed among adolescents, it is not restricted to this age group and can affect individuals of various ages. The severity of this condition can vary, ranging from a mild presentation with only a few comedones to more severe forms characterized by disfiguring inflammatory manifestations, which can lead to hyperpigmentation, scarring, and adverse psychological effects.Acne vulgaris is commonly observed in adolescents and young adults. Its prevalence rates are estimated to range from 35% to over 90% among adolescents. The natural course of this disease can commence as early as ages 7-12 (preadolescent acne) and resolve by the third decade of an individual’s life. However, there are instances where acne can persist into adulthood or even develop for the first time during adulthood.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-28
• Study Start: 2025-05-26

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Aged between 18-65 years 2.
• Both male and female 3.
• Participants diagnosed with acne vulgaris on face with mild to moderate severity 4.
• Willing to give Informed Consent.
• Willing to complete the study assessments/questionnaires.
• Willing to avoid usage of his/her own skin care products for at least one week before the commencement and during this study.

Exclusion Criteria

• Pregnancy or breast feeding.
• Participants with history of hypersensitivity to skin care products.
• Participants with mild to severe anaphylaxis reaction.
• Participants with pre-existing severe systemic disease necessitating long term medication.
• Participants with any other concomitant skin diseases such as psoriasis, eczema etc.
• Evidence of significant uncontrolled co-morbid disease which in the investigators opinion would jeopardize patient participation.
• History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ.
• Participation in the current or previous clinical trial with any approved or investigational products during the past 1 month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcomes:	Day 0,Day 7,Day 15,Day 30.
• Acne quality of life index	Day 0,Day 7,Day 15,Day 30.
questionnaire (AQOLI) questionnaire	Day 0,Day 7,Day 15,Day 30.
• Sebumeter	Day 0,Day 7,Day 15,Day 30.
• Global Acne Grading System (GAGS)	Day 0,Day 7,Day 15,Day 30.

Secondary Outcome Measures

Name	Time	Method
Dermatological Assessments	Day 7,Day 15,Day 30.

Trial Locations

Locations (1)

The Oxford Medical College ,Hospital & Research Centre; 🇮🇳 Bangalore, KARNATAKA, India

The Oxford Medical College ,Hospital & Research Centre

🇮🇳Bangalore, KARNATAKA, India

Dr Anupama mp

Principal investigator

7702185084

DRANUPAMA.MP@GMAIL.COM