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
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
Dr Prathambigai S S
Saveetha Medical College and Hospital
