Clinical trial NCT04899843: Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients
Official title: Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients: A Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: AV Zinc GAGS Serum zinc level
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 122
Sex: ALL
Minimum age (years): 11
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Newly diagnosed Acne vulgaris patients
Primary purpose: TREATMENT

Brief summary: The study was 8 weeks, randomized, double-blind, placebo-controlled trial to assess the effect of zinc sulphate on symptoms of mild and moderate acne vulgaris in 122 patients. Participants was assessed at baseline, and 8 weeks. Subjects was randomized to receive either 20 mg elemental zinc daily or 20 mg placebo tablet daily for 8 weeks. The primary outcome was the measure of the GAGS score and the secondary measure includes serum zinc level and evaluate adverse effects.

Detailed description: Acne vulgaris (AV) is the eighth most prevalent disease worldwide. Acne is a self-limiting condition, it may cause significant psychological and social problems, depression, disfigurement, and scarring that can persist for a lifetime. Multiple factors contribute to acne pathogenesis including increased sebum production, aberrant keratinization of the pilosebaceous duct, bacteria such as Propionibacterium acnes, hormonal influences, the skin microbiome, and chronic inflammation. Relapse rates in patients with acne after treatment with standard of care vary between 10% and 60%. Recent trials attempted to assess the effect of zinc in reducing the severity of symptoms of acne vulgaris patients. This study evaluates whether there is any role of zinc in reducing acne symptoms between those who did and did not receive zinc in an 8 weeks period. This includes 122 acne vulgaris patients who were recruited from Dermatology and Venereology OPD of BSMMU. Participants took either 20 mg elemental zinc daily in the form of zinc sulphate tablet or 20 mg placebo tablet daily for 8 weeks. Initially, baseline serum zinc level was measured and repeated again after 8 weeks of intervention. A baseline acne symptoms survey was done by GAGS score and also repeated at 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed mild and moderate AV patients diagnosed by a dermatologist at the outpatient Department of Dermatology and Venereology,
* Age: 11-35 years,
* Gender: Both male and female

Exclusion Criteria:

* Pregnancy and lactation,
* History of oral contraceptive pills, zinc, and iron intake,
* Suffering from any cosmetic induced acne

Primary outcomes:
measure: Acne vulgaris severity score assessment
timeFrame: 8 weeks
Secondary outcomes:
measure: Biochemical assessment and evaluate the adverse effects
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Basic Science and Paraclinical Science of BSMMU
Study officials:
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: Prof. Md. Sayedur Rahman, MBBS, Mphil, FCPS
role: STUDY_CHAIR
References: