Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients

Acne Vulgaris Clinical Trial

Official title:

A Randomized, Double Blind, Placebo-Controlled Clinical Trial of the Effects of Oral Zinc Gluconate Among Diagnosed Acne Vulgaris Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05096312
• Other study ID #: EAMC IERB 2018-52
• Status: Completed
• Phase: Phase 4
• Start date: December 21, 2018
• Est. completion date: July 20, 2019

Study information

• Verified date: April 2022
• Source: East Avenue Medical Center, Philippines
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 20, 2019
• Est. primary completion date: July 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 27 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Dietary Supplement:
• Zinc gluconate
oral zinc gluconate 200mg

Drug:
• 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

Other:
• Placebo
contains cornstarch

Locations

Country	Name	City	State
Philippines	East Avenue Medical Center	Quezon City	Metro Manila

Sponsors (1)

Lead Sponsor	Collaborator
East Avenue Medical Center, Philippines

Country where clinical trial is conducted

Philippines, 

References & Publications (32)

Al-Shobaili HA. Oxidants and anti-oxidants status in acne vulgaris patients with varying severity. Ann Clin Lab Sci. 2014 Spring;44(2):202-7. — View Citation

Amer M, Bahgat MR, Tosson Z, Abdel Mowla MY, Amer K. Serum zinc in acne vulgaris. Int J Dermatol. 1982 Oct;21(8):481-4. — View Citation

Arora PN, Dhillon KS, Rajan SR, Sayal SK, Das AL. Serum Zinc Levels in Cutaneous Disorders. Med J Armed Forces India. 2002 Oct;58(4):304-6. doi: 10.1016/S0377-1237(02)80083-1. Epub 2011 Jul 21. — View Citation

Bae YS, Hill ND, Bibi Y, Dreiher J, Cohen AD. Innovative uses for zinc in dermatology. Dermatol Clin. 2010 Jul;28(3):587-97. doi: 10.1016/j.det.2010.03.006. Review. — View Citation

Bhate K, Williams HC. Epidemiology of acne vulgaris. Br J Dermatol. 2013 Mar;168(3):474-85. doi: 10.1111/bjd.12149. Review. — View Citation

Bibi Nitzan Y, Cohen AD. Zinc in skin pathology and care. J Dermatolog Treat. 2006;17(4):205-10. Review. — View Citation

Bray TM, Bettger WJ. The physiological role of zinc as an antioxidant. Free Radic Biol Med. 1990;8(3):281-91. Review. — View Citation

Buxaderas SC, Farré-Rovira R. Whole blood and serum zinc levels in relation to sex and age. Rev Esp Fisiol. 1985 Dec;41(4):463-70. — View Citation

Collier CN, Harper JC, Cafardi JA, Cantrell WC, Wang W, Foster KW, Elewski BE. The prevalence of acne in adults 20 years and older. J Am Acad Dermatol. 2008 Jan;58(1):56-9. Epub 2007 Oct 22. Erratum in: J Am Acad Dermatol. 2008 May;58(5):874. Cafardi, Jennifer A [added]. — View Citation

Cunliffe WJ, Burke B, Dodman B, Gould DJ. A double-blind trial of a zinc sulphate/citrate complex and tetracycline in the treatment of acne vulgaris. Br J Dermatol. 1979 Sep;101(3):321-5. — View Citation

Dreno B, Amblard P, Agache P, Sirot S, Litoux P. Low doses of zinc gluconate for inflammatory acne. Acta Derm Venereol. 1989;69(6):541-3. — View Citation

Dreno B, Foulc P, Reynaud A, Moyse D, Habert H, Richet H. Effect of zinc gluconate on propionibacterium acnes resistance to erythromycin in patients with inflammatory acne: in vitro and in vivo study. Eur J Dermatol. 2005 May-Jun;15(3):152-5. — View Citation

Dreno B, Moyse D, Alirezai M, Amblard P, Auffret N, Beylot C, Bodokh I, Chivot M, Daniel F, Humbert P, Meynadier J, Poli F; Acne Research and Study Group. Multicenter randomized comparative double-blind controlled clinical trial of the safety and efficacy of zinc gluconate versus minocycline hydrochloride in the treatment of inflammatory acne vulgaris. Dermatology. 2001;203(2):135-40. — View Citation

Göransson K, Lidén S, Odsell L. Oral zinc in acne vulgaris: a clinical and methodological study. Acta Derm Venereol. 1978;58(5):443-8. — View Citation

Goulden V, Stables GI, Cunliffe WJ. Prevalence of facial acne in adults. J Am Acad Dermatol. 1999 Oct;41(4):577-80. — View Citation

Gupta M, Mahajan VK, Mehta KS, Chauhan PS. Zinc therapy in dermatology: a review. Dermatol Res Pract. 2014;2014:709152. doi: 10.1155/2014/709152. Epub 2014 Jul 10. Review. — View Citation

Hillström L, Pettersson L, Hellbe L, Kjellin A, Leczinsky CG, Nordwall C. Comparison of oral treatment with zinc sulphate and placebo in acne vulgaris. Br J Dermatol. 1977 Dec;97(6):681-4. — View Citation

Humphrey S. Antibiotic resistance in acne treatment. Skin Therapy Lett. 2012 Oct;17(9):1-3. Review. — View Citation

Jarrousse V, Castex-Rizzi N, Khammari A, Charveron M, Dréno B. Zinc salts inhibit in vitro Toll-like receptor 2 surface expression by keratinocytes. Eur J Dermatol. 2007 Nov-Dec;17(6):492-6. Epub 2007 Oct 19. — View Citation

Michaëlsson G, Juhlin L, Ljunghall K. A double-blind study of the effect of zinc and oxytetracycline in acne vulgaris. Br J Dermatol. 1977 Nov;97(5):561-6. — View Citation

Michaëlsson G, Vahlquist A, Juhlin L. Serum zinc and retinol-binding protein in acne. Br J Dermatol. 1977 Mar;96(3):283-6. — View Citation

Ozuguz P, Dogruk Kacar S, Ekiz O, Takci Z, Balta I, Kalkan G. Evaluation of serum vitamins A and E and zinc levels according to the severity of acne vulgaris. Cutan Ocul Toxicol. 2014 Jun;33(2):99-102. doi: 10.3109/15569527.2013.808656. Epub 2013 Jul 5. — View Citation

Prasad AS. Zinc is an Antioxidant and Anti-Inflammatory Agent: Its Role in Human Health. Front Nutr. 2014 Sep 1;1:14. doi: 10.3389/fnut.2014.00014. eCollection 2014. Review. — View Citation

Rostami Mogaddam M, Safavi Ardabili N, Maleki N, Soflaee M. Correlation between the severity and type of acne lesions with serum zinc levels in patients with acne vulgaris. Biomed Res Int. 2014;2014:474108. doi: 10.1155/2014/474108. Epub 2014 Jul 24. — View Citation

Rostan EF, DeBuys HV, Madey DL, Pinnell SR. Evidence supporting zinc as an important antioxidant for skin. Int J Dermatol. 2002 Sep;41(9):606-11. Review. — View Citation

Sardana K, Chugh S, Garg VK. The role of zinc in acne and prevention of resistance: have we missed the "base" effect? Int J Dermatol. 2014 Jan;53(1):125-7. doi: 10.1111/ijd.12264. — View Citation

Sardana K, Garg VK. An observational study of methionine-bound zinc with antioxidants for mild to moderate acne vulgaris. Dermatol Ther. 2010 Jul-Aug;23(4):411-8. doi: 10.1111/j.1529-8019.2010.01342.x. — View Citation

Stein Gold L, Weiss J, Rueda MJ, Liu H, Tanghetti E. Moderate and Severe Inflammatory Acne Vulgaris Effectively Treated with Single-Agent Therapy by a New Fixed-Dose Combination Adapalene 0.3 %/Benzoyl Peroxide 2.5 % Gel: A Randomized, Double-Blind, Parallel-Group, Controlled Study. Am J Clin Dermatol. 2016 Jun;17(3):293-303. doi: 10.1007/s40257-016-0178-4. — View Citation

Tan JK, Bhate K. A global perspective on the epidemiology of acne. Br J Dermatol. 2015 Jul;172 Suppl 1:3-12. doi: 10.1111/bjd.13462. Review. — View Citation

Thiboutot DM, Dréno B, Abanmi A, Alexis AF, Araviiskaia E, Barona Cabal MI, Bettoli V, Casintahan F, Chow S, da Costa A, El Ouazzani T, Goh CL, Gollnick HPM, Gomez M, Hayashi N, Herane MI, Honeyman J, Kang S, Kemeny L, Kubba R, Lambert J, Layton AM, Leyden JJ, López-Estebaranz JL, Noppakun N, Ochsendorf F, Oprica C, Orozco B, Perez M, Piquero-Martin J, See JA, Suh DH, Tan J, Lozada VT, Troielli P, Xiang LF. Practical management of acne for clinicians: An international consensus from the Global Alliance to Improve Outcomes in Acne. J Am Acad Dermatol. 2018 Feb;78(2 Suppl 1):S1-S23.e1. doi: 10.1016/j.jaad.2017.09.078. Epub 2017 Nov 8. Review. — View Citation

Vahlquist A, Michaëlsson G, Juhlin L. Acne treatment with oral zinc and vitamin A: effects on the serum levels of zinc and retinol binding protein (RBP). Acta Derm Venereol. 1978;58(5):437-42. — View Citation

Verma KC, Saini AS, Dhamija SK. Oral zinc sulphate therapy in acne vulgaris: a double-blind trial. Acta Derm Venereol. 1980;60(4):337-40. doi: 10.2340/0001555560337340. — View Citation

* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	upon enrollment, at 4 weeks, at 8 weeks
Primary	Inflammatory Score	changes in inflammatory score. Minimum score is 0, maximum score is 144. Higher score indicates presence of more inflammation.	upon enrollment, at 4 weeks, at 8 weeks
Secondary	Examiner's Assessment Score	examiner's assessment of acne improvement graded as no improvement (0%), slight improvement (<50%), marked improvement (=50%)	at 8 weeks
Secondary	Patient's Self-assessment Score	patient's assessment of acne improvement graded as no improvement (0%), slight improvement (<50%), marked improvement (=50%)	at 8 weeks

External Links

•   A Cross-Sectional Study on the Impact of Acne Vulgaris on the Quality of Life among High School Students in Pasig City, Philippines
•   Drug Bank zinc gluconate
•   Evaluation of Severity in Patients of Acne Vulgaris by Global Acne Grading System in Bangladesh
•   Kahalagahan ng zinc sa kalusugan (importance of zinc for health)
•   NIH Zinc fact sheet
•   Serum Trace Elements (Zinc, Copper and Magnesium) Status in Iraqi Patients with Acne Vulgaris: (Case- Controlled Study)
•   summary of zinc
•   Zinc for testosterone
•   Zinc levels in patients with acne vulgaris
•   Zinc status of Filipinos by serum zinc level