NCT04975412

Brief Summary

Acne Vulgaris is one of the most common dermatologic diagnoses in the world. A number of studies have been conducted comparing serum zinc levels with acne vulgaris; however, no studies have yet been done in the Philippine setting. The objective of this study is to determine the relationship between whole blood zinc levels and the severity of acne vulgaris in Filipino patients and normal controls who are 18-25 years old.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2018

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
Last Updated

August 3, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

July 14, 2021

Last Update Submit

July 27, 2021

Conditions

Acne Vulgaris

Keywords

Acne VulgarisZinc in bloodGlobal Acne Grading System

Outcome Measures

Primary Outcomes (2)

  • Acne severity

    Based on the Global Acne Grading System (GAGS) score. Minimum value 0, maximum value 44. Acne severity is rated as mild (1-18), moderate (19-30), severe (31-38), and very severe (≥39). Control patients have GAGS score of 0.

    initial consult

  • Whole blood zinc level

    whole blood zinc level in µg/mL

    initial consult

Secondary Outcomes (1)

  • demographics

    initial consult

Study Arms (2)

acne vulgaris group (cases)

Filipino patients, aged 18-25 years old with diagnosis of Acne Vulgaris

Diagnostic Test: Whole blood zinc level

control group

healthy Filipino patients, aged 18-25 years old

Diagnostic Test: Whole blood zinc level

Interventions

Whole blood zinc levelDIAGNOSTIC_TEST

whole blood zinc levels determined through ashing acid digestion-inductively coupled plasma (ICP) using Shimadzu ICPS-7510, an inductively coupled plasma emission spectrometer.

acne vulgaris group (cases)control group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The subjects of the study included patients clinically diagnosed with acne vulgaris and healthy controls, aged 18-25 years of age.

You may qualify if:

  • Filipino patients, aged 18-25 years old
  • Diagnosis of acne vulgaris
  • Able to read and write in English or Tagalog
  • Seen at the dermatology out-patient department of East Avenue Medical Center

You may not qualify if:

  • Patients with other chronic dermatoses or systemic disease
  • Taking oral supplements or medications for the past 3 months
  • Patients who are pregnant or lactating
  • Filipino patients, aged 18-25 years old
  • Able to read and write in English or Tagalog
  • Seen at the dermatology out-patient department of East Avenue Medical Center
  • Patients with acne vulgaris or other chronic dermatoses or systemic disease
  • Taking oral supplements or medications for the past 3 months
  • Patients who are pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Avenue Medical Center

Quezon City, National Capital Region, 1100, Philippines

Location

Related Publications (33)

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    PMID: 23210645BACKGROUND

  • 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.

    PMID: 25988117BACKGROUND

  • 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.

    PMID: 25597339BACKGROUND

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    PMID: 24795060BACKGROUND

  • 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. doi: 10.1046/j.1365-4362.2002.01567.x.

    PMID: 12358835BACKGROUND

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

    PMID: 4095368BACKGROUND

  • 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.

    PMID: 25157359BACKGROUND

  • Michaelsson G, Vahlquist A, Juhlin L. Serum zinc and retinol-binding protein in acne. Br J Dermatol. 1977 Mar;96(3):283-6. doi: 10.1111/j.1365-2133.1977.tb06138.x.

    PMID: 139912BACKGROUND

  • Adityan B, Kumari R, Thappa DM. Scoring systems in acne vulgaris. Indian J Dermatol Venereol Leprol. 2009 May-Jun;75(3):323-6. doi: 10.4103/0378-6323.51258. No abstract available.

    PMID: 19439902BACKGROUND

  • 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.

    PMID: 23826827BACKGROUND

  • Ikaraoha CI, Mbadiwe NC, Anyanwu CJ, Odekhian J, Nwadike CN, Amah HC. The Role of Blood Lead, Cadmium, Zinc and Copper in Development and Severity of Acne Vulgaris in a Nigerian Population. Biol Trace Elem Res. 2017 Apr;176(2):251-257. doi: 10.1007/s12011-016-0839-4. Epub 2016 Sep 6.

    PMID: 27600928BACKGROUND

  • 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. doi: 10.1111/j.1365-4362.1982.tb03188.x.

    PMID: 6217164BACKGROUND

  • 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.

    PMID: 27407419BACKGROUND

  • Canavan TN, Chen E, Elewski BE. Optimizing Non-Antibiotic Treatments for Patients with Acne: A Review. Dermatol Ther (Heidelb). 2016 Dec;6(4):555-578. doi: 10.1007/s13555-016-0138-1. Epub 2016 Aug 19.

    PMID: 27541148BACKGROUND

  • 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.

    PMID: 25120566BACKGROUND

  • 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. No abstract available.

    PMID: 24350859BACKGROUND

  • Bray TM, Bettger WJ. The physiological role of zinc as an antioxidant. Free Radic Biol Med. 1990;8(3):281-91. doi: 10.1016/0891-5849(90)90076-u.

    PMID: 2187766BACKGROUND

  • Lim KH, Riddell LJ, Nowson CA, Booth AO, Szymlek-Gay EA. Iron and zinc nutrition in the economically-developed world: a review. Nutrients. 2013 Aug 13;5(8):3184-211. doi: 10.3390/nu5083184.

    PMID: 23945676BACKGROUND

  • Plum LM, Rink L, Haase H. The essential toxin: impact of zinc on human health. Int J Environ Res Public Health. 2010 Apr;7(4):1342-65. doi: 10.3390/ijerph7041342. Epub 2010 Mar 26.

    PMID: 20617034BACKGROUND

  • Oteiza PI. Zinc and the modulation of redox homeostasis. Free Radic Biol Med. 2012 Nov 1;53(9):1748-59. doi: 10.1016/j.freeradbiomed.2012.08.568. Epub 2012 Aug 25.

    PMID: 22960578BACKGROUND

  • Maret W. Zinc biochemistry: from a single zinc enzyme to a key element of life. Adv Nutr. 2013 Jan 1;4(1):82-91. doi: 10.3945/an.112.003038.

    PMID: 23319127BACKGROUND

  • Rangan AM, Samman S. Zinc intake and its dietary sources: results of the 2007 Australian National Children's Nutrition and Physical Activity Survey. Nutrients. 2012 Jul;4(7):611-24. doi: 10.3390/nu4070611. Epub 2012 Jun 26.

    PMID: 22852053BACKGROUND

  • Toyoda M, Morohashi M. Pathogenesis of acne. Med Electron Microsc. 2001 Mar;34(1):29-40. doi: 10.1007/s007950100002.

    PMID: 11479771BACKGROUND

  • Aydemir EH. Acne vulgaris. Turk Pediatri Ars. 2014 Mar 1;49(1):13-6. doi: 10.5152/tpa.2014.1943. eCollection 2014 Mar.

    PMID: 26078626BACKGROUND

  • Akhtar S. Zinc status in South Asian populations--an update. J Health Popul Nutr. 2013 Jun;31(2):139-49. doi: 10.3329/jhpn.v31i2.16378.

    PMID: 23930332BACKGROUND

  • Eady EA, Gloor M, Leyden JJ. Propionibacterium acnes resistance: a worldwide problem. Dermatology. 2003;206(1):54-6. doi: 10.1159/000067822.

    PMID: 12566805BACKGROUND

  • Eady EA, Cove JH, Holland KT, Cunliffe WJ. Erythromycin resistant propionibacteria in antibiotic treated acne patients: association with therapeutic failure. Br J Dermatol. 1989 Jul;121(1):51-7. doi: 10.1111/j.1365-2133.1989.tb01399.x.

    PMID: 2527056BACKGROUND

  • Ross JI, Snelling AM, Carnegie E, Coates P, Cunliffe WJ, Bettoli V, Tosti G, Katsambas A, Galvan Perez Del Pulgar JI, Rollman O, Torok L, Eady EA, Cove JH. Antibiotic-resistant acne: lessons from Europe. Br J Dermatol. 2003 Mar;148(3):467-78. doi: 10.1046/j.1365-2133.2003.05067.x.

    PMID: 12653738BACKGROUND

  • Cooper AJ. Systematic review of Propionibacterium acnes resistance to systemic antibiotics. Med J Aust. 1998 Sep 7;169(5):259-61. doi: 10.5694/j.1326-5377.1998.tb140250.x.

    PMID: 9762064BACKGROUND

  • Leyden JJ, McGinley KJ, Cavalieri S, Webster GF, Mills OH, Kligman AM. Propionibacterium acnes resistance to antibiotics in acne patients. J Am Acad Dermatol. 1983 Jan;8(1):41-5. doi: 10.1016/s0190-9622(83)70005-8.

    PMID: 6219134BACKGROUND

Related Links

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Monique Lianne C. Lim-Ang, MD,MBA,DPDS

    East Avenue Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 14, 2021

First Posted

July 23, 2021

Study Start

November 27, 2017

Primary Completion

March 16, 2018

Study Completion

March 16, 2018

Last Updated

August 3, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

PH(1)