Acne Vulgaris
Conditions
Keywords
acne vulgaris, zinc gluconate, inflammation, adapalene, benzoyl peroxide, Global Acne Grading System
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.
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 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening. Improvement in acne severity was then determined and compared.
Interventions
DIETARY_SUPPLEMENTZinc gluconate
oral zinc gluconate 200mg
DRUGAdapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]
Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening
OTHERPlacebo
contains cornstarch
Sponsors
East Avenue Medical Center, Philippines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 27 Years
Healthy volunteers
No
Inclusion criteria
* Filipino patients, aged 18-27 years old * New patients diagnosed with Acne Vulgaris with a Global Acne Grading System score of at least 19 * Able to read and write in English or Tagalog * Seen at the Dermatology out-patient clinic of East Avenue Medical Center
Exclusion criteria
* Patients with other chronic dermatoses or systemic disease * Taking oral supplements or medications within the past 4 weeks * Patients who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Acne Grading System Score | upon enrollment, at 4 weeks, at 8 weeks | changes in Global Acne Grading System (GAGS) score. Minimum score is 0, maximum score is 44. Cut off scores are as follows: no lesion (0), mild (1-18), moderate (19-30), severe (31-38), and very severe (≥39) |
| Inflammatory Score | upon enrollment, at 4 weeks, at 8 weeks | changes in inflammatory score. Minimum score is 0, maximum score is 144. Higher score indicates presence of more inflammation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's Self-assessment Score | at 8 weeks | patient's assessment of acne improvement graded as no improvement (0%), slight improvement (\<50%), marked improvement (≥50%) |
| Examiner's Assessment Score | at 8 weeks | examiner's assessment of acne improvement graded as no improvement (0%), slight improvement (\<50%), marked improvement (≥50%) |
Countries
Philippines
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zinc Gluconate Group interventions: Zinc gluconate (200g/capsule) one capsule once in the morning after breakfast for 60 days.
Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.
Zinc gluconate: oral zinc gluconate 200mg
Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel \[Epiduo\]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening | 8 |
| Placebo Group interventions: Placebo capsule, one capsule once in the morning after breakfast for 60 days. Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days.
Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel \[Epiduo\]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening
Placebo: contains cornstarch | 8 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 4 |
Baseline characteristics
| Characteristic | Zinc Gluconate Group | Placebo Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 5 Participants | 1 Participants | 6 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 7 Participants | 10 Participants |
| Global Acne Grading System score | 32 units on a scale | 30.33 units on a scale | 31.5 units on a scale |
| Inflammatory Score | 70 units on a scale | 48.5 units on a scale | 62.84 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 8 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Philippines | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 12 |
| other Total, other adverse events | 1 / 11 | 0 / 12 |
| serious Total, serious adverse events | 0 / 11 | 0 / 12 |
Outcome results
Primary
Global Acne Grading System Score
changes in Global Acne Grading System (GAGS) score. Minimum score is 0, maximum score is 44. Cut off scores are as follows: no lesion (0), mild (1-18), moderate (19-30), severe (31-38), and very severe (≥39)
Time frame: upon enrollment, at 4 weeks, at 8 weeks
Population: the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Zinc Gluconate Group | Global Acne Grading System Score | Initial | 32 score on a scale |
| Zinc Gluconate Group | Global Acne Grading System Score | 4 weeks | 21.67 score on a scale |
| Zinc Gluconate Group | Global Acne Grading System Score | 8 weeks | 14.34 score on a scale |
| Placebo Group | Global Acne Grading System Score | Initial | 30.33 score on a scale |
| Placebo Group | Global Acne Grading System Score | 4 weeks | 27.5 score on a scale |
| Placebo Group | Global Acne Grading System Score | 8 weeks | 21.67 score on a scale |
Primary
Inflammatory Score
changes in inflammatory score. Minimum score is 0, maximum score is 144. Higher score indicates presence of more inflammation.
Time frame: upon enrollment, at 4 weeks, at 8 weeks
Population: the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Zinc Gluconate Group | Inflammatory Score | Initial | 70 score on a scale |
| Zinc Gluconate Group | Inflammatory Score | 4 weeks | 22.67 score on a scale |
| Zinc Gluconate Group | Inflammatory Score | 8 weeks | 8.34 score on a scale |
| Placebo Group | Inflammatory Score | Initial | 48.5 score on a scale |
| Placebo Group | Inflammatory Score | 4 weeks | 47.5 score on a scale |
| Placebo Group | Inflammatory Score | 8 weeks | 22.67 score on a scale |
Secondary
Examiner's Assessment Score
examiner's assessment of acne improvement graded as no improvement (0%), slight improvement (\<50%), marked improvement (≥50%)
Time frame: at 8 weeks
Population: the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zinc Gluconate Group | Examiner's Assessment Score | No Improvement | 0 Participants |
| Zinc Gluconate Group | Examiner's Assessment Score | Slight Improvement (<50%) | 0 Participants |
| Zinc Gluconate Group | Examiner's Assessment Score | Marked Improvement (≥50%) | 8 Participants |
| Placebo Group | Examiner's Assessment Score | No Improvement | 0 Participants |
| Placebo Group | Examiner's Assessment Score | Slight Improvement (<50%) | 0 Participants |
| Placebo Group | Examiner's Assessment Score | Marked Improvement (≥50%) | 8 Participants |
Secondary
Patient's Self-assessment Score
patient's assessment of acne improvement graded as no improvement (0%), slight improvement (\<50%), marked improvement (≥50%)
Time frame: at 8 weeks
Population: the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zinc Gluconate Group | Patient's Self-assessment Score | Marked improvement (≥50%) | 8 Participants |
| Zinc Gluconate Group | Patient's Self-assessment Score | No improvement | 0 Participants |
| Zinc Gluconate Group | Patient's Self-assessment Score | Slight improvement (<50%) | 0 Participants |
| Placebo Group | Patient's Self-assessment Score | Slight improvement (<50%) | 0 Participants |
| Placebo Group | Patient's Self-assessment Score | No improvement | 0 Participants |
| Placebo Group | Patient's Self-assessment Score | Marked improvement (≥50%) | 8 Participants |