Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients

NCT05096312 | Completed Phase 4 Results FDA Drug

• 1 other identifier: EAMC IERB 2018-52
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Keywords

acne vulgaris; zinc gluconate; inflammation; adapalene; benzoyl peroxide; Global Acne Grading System

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Examiner's Assessment Score

  at 8 weeks

• Patient's Self-assessment Score

  at 8 weeks

Study Arms (2)

Zinc gluconate group

ACTIVE COMPARATOR

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.

Dietary Supplement: Zinc gluconate; Drug: Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]

Placebo group

PLACEBO COMPARATOR

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.

Drug: Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]; Other: Placebo

Interventions

Zinc gluconate DIETARY_SUPPLEMENT

oral zinc gluconate 200mg

Also known as: Solgar zinc gluconate

Zinc gluconate group

Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo] DRUG

Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening

Also known as: Epiduo Forte

Placebo group; Zinc gluconate group

Placebo OTHER

contains cornstarch

Placebo group

Eligibility Criteria

• Age: 18 Years - 27 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients with other chronic dermatoses or systemic disease
• Taking oral supplements or medications within the past 4 weeks
• Patients who are pregnant or lactating

Sponsors & Collaborators

• East Avenue Medical Center, Philippines: lead

Study Sites (1)

East Avenue Medical Center

Quezon City, National Capital Region, Philippines

Location

Related Publications (32)

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Related Links

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

MeSH Terms

Conditions

Acne Vulgaris; Inflammation

Interventions

gluconic acid; Adapalene; Benzoyl Peroxide; Gels; Adapalene, Benzoyl Peroxide Drug Combination

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Drug Combinations

Results Point of Contact

• Title: Dr. Monqiue Lianne Lim-Ang
• Organization: East Avenue Medical Center

moniquelianne.lim@gmail.com

0287100957

Study Officials

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

  East Avenue Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 27, 2021
• Study Start: December 21, 2018
• Primary Completion: July 19, 2019
• Study Completion: July 20, 2019
• Last Updated: May 11, 2022
• Results First Posted: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)