Skip to main content
Clinical Trials/CTRI/2025/02/080180
CTRI/2025/02/080180Not yet recruitingNot Applicable

To study the effectiveness of novel combination hydrogel pimple patch containing Azelaic acid, Salicylic acid and Zinc oxide versus conventional topical spot treatment available for the treatment of acne vulgaris : a randomized control trial

Dr Prathambigai S S1 site in 1 country50 target enrollmentStarted: February 17, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
erythema, diameter of lesions and pigmentation

Study Overview

Brief Summary

This is a randomized, open labelled, parallel group, single-centre trial comparing the safety and efficacy of a novel combination pimple patch containing 1% Salicylic acid, 3% Azelaic acid and Zinc oxide and a conventional spot treatment of 0.1% Adapalene and 1% Clindamycin combination gel for 6 months in 50 patients with acne vulgaris that will be conducted in Saveetha Medical College and Hospital, a tertiary care hospital in India. The primary outcome measures erythema, diameter and pigmentation at day 1,3,5, 7 and 10 of treatment .

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients aged between 18 and 40 years.
  • 2.Patients clinically diagnosed with Pillsbury Grade 1 and 2 acne where lesion size is less than 1cm
  • Patients not on any other topical treatment for acne vulgaris
  • Patients who are reliable and compliant for regular follow-up.

Exclusion Criteria

  • Patients with Pillsbury Grade 3 and greater acne
  • Patients on other topical treatments for acne vulgaris
  • Patients having other dermatological conditions like Psoriasis, eczema
  • Children below the age of 18 years
  • Pregnant and lactating women
  • Patients with hypersensitivity/ allergy to Aspirin
  • Patients with hypersensitivity to hydrogel patch.

Outcomes

Primary Outcomes

erythema, diameter of lesions and pigmentation

Time Frame: Days 1,3,5,7,10 after application

Secondary Outcomes

  • physician assessment grading of lesions(Days 1,3,5,7,10 after application)

Investigators

Sponsor
Dr Prathambigai S S
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Prathambigai S S

Saveetha Medical College and Hospital

Study Sites (1)

Loading locations...

Similar Trials