Determine the effect of oral zinc therapy in Acne Vulgaris disease
Design
Clinical trial with a control group, one blind, randomized
Settings and conduct
In this study 100 patients with Acne Vulgaris referred to the clinic Khalij-e-Fars of Bushehr 2 in the year 2017-2018, based on the inclusion and exclusion criteria, were randomly allocated in two groups of intervention and control are included. The control group received routine acne vulgaris treatment alone (including 1% localized clindamycin gel and 1% salicylic acid topical), and the intervention group received routine Acne Vulgaris plus 60 mg daily oral zinc sulfate.Patients are treated for 12 weeks. At the start of the treatment and every visit, the doctor will estimate the number of lesions and at the end of the treatment period, the rate of recovery and possible side effects in both groups of the improvement degree. These data provided in the checklist for information purposes by the researcher. Data will be analyzed by a statistician without knowing the type of patient treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
2nd and 3rd grade of Acne Vulgaris patients based on Pillsburg classification
Exclusion criteria:
The patients with Gastrointestinal disorder
The pregnant patients and breast feeding mothers
Using other topical and oral anti Acne drugs
Patients with Grade 1 and 4 Acne Vulgaris
Female patients with hormonal disorders
Patients with oral Isotretinoin in the last 3 months
In case of no timely referral of the patient to evaluate the treatment
In case of intolerance to the digestive tract by the patient
Intervention groups
Giving 60 mg oral Zinc daily to 50 patients with Acne Vulgaris and examining patients every 2 weeks for recovery.
Choosing 50 Patients with Acne Vulgaris Without oral Zinc tablets
Main outcome variables
Reduce or eliminate signs and symptoms of Acne Vulgaris disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190505043485N1
Registration date:2019-06-01, 1398/03/11
Registration timing:registered_while_recruiting
Last update:2019-06-01, 1398/03/11
Update count:0
Registration date
2019-06-01, 1398/03/11
Registrant information
Name
Sakineh Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3727 9123
Email address
aminboldaji@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-11, 1398/02/21
Expected recruitment end date
2019-06-11, 1398/03/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of the Effect of Oral zinc therapy on the Treatment of Acne vulgaris in Patients with Grade 2 and 3 Acne vulgaris
Public title
Evaluation of oral zinc therapy in Acne Vulgaris disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
2nd and 3rd grade of Acne Vulgaris patients depends on Pillsburg classification
Exclusion criteria:
The patients with Gastrointestinal disorder
The pregnant patients and breast feeding mothers
Using other topical and oral anti Acne drugs
Patients with Grade 1 and 4 Acne Vulgaris
Female patients with hormonal disorders
Patients with oral Isotretinoin in the last 3 months
Age
From 15 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Among the patients with Acne Vulgaris referred to the Khalij-e-Fars clinic of Bushehr, who are eligible for inclusion in the study, 100 patients are randomly selected and divided into Intervention and control groups by block method, each group Includes 50 patients.To do this, 50 sealed envelopes are used as envelopes A and 50 sealed envelopes as B envelopes. People who select envelope A fall into the control group and those who choose B envelope fall into the intervention group
Blinding (investigator's opinion)
Single blinded
Blinding description
Data will be analyzed by a statistician without knowing the type of patient treatment
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Boushehr University of Medical Sciences
Street address
Salman Farsi st
City
Boushehr
Province
Boushehr
Postal code
7514633341
Approval date
2019-05-08, 1398/02/18
Ethics committee reference number
IR.BPUMS.REC.1398.023
Health conditions studied
1
Description of health condition studied
Acne Vulgaris
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
Reduce in number of Acne
Timepoint
Evaluation the number of Acne in 14 days
Method of measurement
Observational
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group in addition to the routine treatment of Acne Vulgaris (containing 1% topical Clindamycin gel and 1% topical Salicylic Acid gel) will receive Zinc Sulfate tablets 60 mg daily orally as a therapeutic intervention for 3 months
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group received only routine Acne Vulgaris treatment without any extra work
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The Khalij e Fars hospital
Full name of responsible person
Doctor Marziyeh Afrouzandeh
Street address
Taleqani blvd
City
Boushehr
Province
Boushehr
Postal code
7517933755
Phone
+98 77 3345 5390
Email
mpgh@bpums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
doctor Gholamreza Khamisi por
Street address
Salman farsi st
City
Boushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
Khamisipoor@bpums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Doctor Marziyeh Afrouzandeh
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Taleqani Blvd
City
Boushehr
Province
Boushehr
Postal code
7517933755
Phone
+98 77 3345 5490
Email
marzieh642004@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Doctor Marziyeh Afrouzandeh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Taleqani Blvd
City
Boushehr
Province
Boushehr
Postal code
7517933755
Phone
+98 77 3345 5390
Email
Marzieh642004@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
doctor Marzieh Afrouzandeh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Taleqani Blvd
City
Boushehr
Province
Boushehr
Postal code
7517933755
Phone
+98 77 2234 5390
Email
Marzieh642004@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available