Trial Outcomes & Findings for Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients (NCT NCT05096312)

Last Updated: 2022-05-11

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

23 participants

Primary outcome timeframe

upon enrollment, at 4 weeks, at 8 weeks

Results posted on

2022-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	11	12
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Lost to Follow-up	2	4
Overall Study Adverse Event	1	0

Baseline Characteristics

the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Zinc Gluconate Group n=8 Participants 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	Placebo Group n=8 Participants 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
Global Acne Grading System Score Initial	32 score on a scale Interval 25.67 to 43.0	30.33 score on a scale Interval 21.0 to 38.33
Global Acne Grading System Score 4 weeks	21.67 score on a scale Interval 19.0 to 29.0	27.5 score on a scale Interval 11.0 to 36.0
Global Acne Grading System Score 8 weeks	14.34 score on a scale Interval 2.0 to 24.67	21.67 score on a scale Interval 7.67 to 27.67

PRIMARY outcome

Timeframe: 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.

changes in inflammatory score. Minimum score is 0, maximum score is 144. Higher score indicates presence of more inflammation.

Outcome measures

Outcome measures
Measure	Zinc Gluconate Group n=8 Participants 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	Placebo Group n=8 Participants 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
Inflammatory Score Initial	70 score on a scale Interval 43.0 to 110.67	48.5 score on a scale Interval 19.67 to 72.33
Inflammatory Score 4 weeks	22.67 score on a scale Interval 12.67 to 42.38	47.5 score on a scale Interval 10.67 to 73.67
Inflammatory Score 8 weeks	8.34 score on a scale Interval 3.0 to 32.33	22.67 score on a scale Interval 10.67 to 51.0

SECONDARY outcome

Timeframe: at 8 weeks

Population: the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.

examiner's assessment of acne improvement graded as no improvement (0%), slight improvement (\<50%), marked improvement (≥50%)

Outcome measures

Outcome measures
Measure	Zinc Gluconate Group n=8 Participants 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	Placebo Group n=8 Participants 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
Examiner's Assessment Score No Improvement	0 Participants	0 Participants
Examiner's Assessment Score Slight Improvement (<50%)	0 Participants	0 Participants
Examiner's Assessment Score Marked Improvement (≥50%)	8 Participants	8 Participants

SECONDARY outcome

Timeframe: at 8 weeks

Population: the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.

patient's assessment of acne improvement graded as no improvement (0%), slight improvement (\<50%), marked improvement (≥50%)

Outcome measures

Outcome measures
Measure	Zinc Gluconate Group n=8 Participants 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	Placebo Group n=8 Participants 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
Patient's Self-assessment Score No improvement	0 Participants	0 Participants
Patient's Self-assessment Score Slight improvement (<50%)	0 Participants	0 Participants
Patient's Self-assessment Score Marked improvement (≥50%)	8 Participants	8 Participants

Adverse Events

Zinc Gluconate Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Zinc Gluconate Group n=11 participants at risk 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	Placebo Group n=12 participants at risk 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
Gastrointestinal disorders vomiting	9.1% 1/11 • Number of events 1 • 6 months	0.00% 0/12 • 6 months

Additional Information

Dr. Monqiue Lianne Lim-Ang

East Avenue Medical Center

Phone: 0287100957

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Zinc Gluconate Group n=8 Participants 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	Placebo Group n=8 Participants 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	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	5 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	1 Participants n=7 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	6 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	7 Participants n=7 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	10 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
Age, Categorical >=65 years	0 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	0 Participants n=7 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	0 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
Sex: Female, Male Female	6 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	6 Participants n=7 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	12 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
Sex: Female, Male Male	2 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	2 Participants n=7 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	4 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	0 Participants n=7 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	0 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
Race (NIH/OMB) Asian	8 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	8 Participants n=7 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	16 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	0 Participants n=7 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	0 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	0 Participants n=7 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	0 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
Race (NIH/OMB) White	0 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	0 Participants n=7 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	0 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	0 Participants n=7 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	0 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	0 Participants n=7 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	0 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
Region of Enrollment Philippines	8 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	8 Participants n=7 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	16 Participants n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
Inflammatory Score	70 units on a scale n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	48.5 units on a scale n=7 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	62.84 units on a scale n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.
Global Acne Grading System score	32 units on a scale n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	30.33 units on a scale n=7 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.	31.5 units on a scale n=5 Participants • the analysis population only consisted of participants who were able to complete 8 weeks of the intervention.