Ignite Creation Date:
2024-05-06 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05096312
Status:
COMPLETED
Last Update Posted:
2022-05-11
First Post:
2021-10-14
Brief Title:
Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients
Sponsor:
East Avenue Medical Center Philippines
Organization:
East Avenue Medical Center Philippines
Study Overview
Official Title:
A Randomized Double Blind Placebo-Controlled Clinical Trial of the Effects of Oral Zinc Gluconate Among Diagnosed Acne Vulgaris Patients
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acne Vulgaris is one of the most common dermatologic diagnoses requiring long-term maintenance therapy Promising results of oral zinc gluconate in improving acne vulgaris has been described
A randomized double blind placebo-controlled clinical trial was utilized for this study with the objective to assess the efficacy of oral zinc gluconate in the improvement of disease activity in acne vulgaris patients as measured by the inflammatory score and Global Acne Grading System GAGS score
A randomized double blind placebo-controlled clinical trial was utilized for this study with the objective to assess the efficacy of oral zinc gluconate in the improvement of disease activity in acne vulgaris patients as measured by the inflammatory score and Global Acne Grading System GAGS score
Detailed Description:
Acne has four main pathogenic contributors follicular hyperkeratinization increased sebum production Propionibacterium acnes P acnes within the follicle and inflammation Treatment options for acne vulgaris include benzoyl peroxide topical and oral retinoids topical and oral antimicrobials oral corticosteroids and physical modalities such as acne surgery laser and light therapy Reports show that antibiotic resistance is a growing issue in the treatment regimen of acne vulgaris making it less and less suitable for long-term treatment hence other options that can be substitutes or adjuncts to treatment may be useful in this condition For long-term or maintenance therapy physicians should consider effectivity cost and adverse effects Several studies have explored the effect of oral zinc on acne vulgaris Since zinc is more cost-effective and has less adverse effects compared to most antibiotics this may prove helpful for the Filipino patient in terms of safety and economy for long-term therapy
The aim of this study is to assess the efficacy of oral zinc gluconate in the improvement of disease activity in acne vulgaris patients to determine the demographic and clinical profile of Acne Vulgaris patients to determine the disease activity measured by the inflammatory score and GAGS score of acne vulgaris patients on initial consult at 4 weeks and at 8 weeks and to determine if there is a significant difference in disease activity as measured by the inflammatory score and GAGS score among acne vulgaris patients given placebo and oral zinc gluconate
A randomized double blind placebo-controlled clinical trial was utilized Adults with moderate to severe acne vulgaris were included in the study Patients were evaluated using the inflammatory score and Global Acne Grading System GAGS at the start at midpoint and at the end of the trial One group of participants received zinc gluconate supplementation and another group received placebo for 60 days All participants received topical adapalene 03 Benzoyl peroxide 25 gel applied once daily in the evening Improvement in acne severity was then determined and compared
The aim of this study is to assess the efficacy of oral zinc gluconate in the improvement of disease activity in acne vulgaris patients to determine the demographic and clinical profile of Acne Vulgaris patients to determine the disease activity measured by the inflammatory score and GAGS score of acne vulgaris patients on initial consult at 4 weeks and at 8 weeks and to determine if there is a significant difference in disease activity as measured by the inflammatory score and GAGS score among acne vulgaris patients given placebo and oral zinc gluconate
A randomized double blind placebo-controlled clinical trial was utilized Adults with moderate to severe acne vulgaris were included in the study Patients were evaluated using the inflammatory score and Global Acne Grading System GAGS at the start at midpoint and at the end of the trial One group of participants received zinc gluconate supplementation and another group received placebo for 60 days All participants received topical adapalene 03 Benzoyl peroxide 25 gel applied once daily in the evening Improvement in acne severity was then determined and compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None