Determining the effect of topical Hypochlorite sodium 0.005% versus placebo in treatment of mild to moderate acne
Design
Randomized double blind Clinical Trial
Settings and conduct
In dermatology clinic of Shahid Faghihi hospital, the patients were assigned to receive Hypochlorite sodium 0.005% or placebo to be administered topically on each side of their face three times a day for one month. Hypochlorite sodium 0.005% and placebo were applied randomly on each side of the patients' faces. On the other hand, the patients were not aware of the type of solution (placebo or Hypochlorite sodium 0.005%) applied for them.In addition to patients, dermatologist and the recorder person were blind about the solution applied for each patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with mild to moderate Acne Vulgaris diagnosed by dermatologist
Exclusion criteria:
Patients with symptoms such as secondary Acne caused by lactation
Dermatology condition in addition to Acne
Patients who had taken drugs such as Isotretinoin or systemic, topical antibiotics within the last two months
Allergy to Hypochlorite Sodium
Intervention groups
Intervention group:The patients received Hypochlorite sodium 0.005% randomly to be administered topically on the right or left side of their faces three times a day for one month.
Control group: The patients received placebo(distilled water) randomly to be administered topically on the right or left side of their faces three times a day for one month.
The patients were not aware of the type of solution (placebo or Hypochlorite sodium 0.005%) applied for them.In addition to patients, dermatologist and the recorder person were both blind about the solution applied for each side of patient's face.
Main outcome variables
Evaluation of Acne remission on the basis of changes in the number of papules and pustules
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200701047976N1
Registration date:2020-07-14, 1399/04/24
Registration timing:prospective
Last update:2020-07-14, 1399/04/24
Update count:0
Registration date
2020-07-14, 1399/04/24
Registrant information
Name
Nafiseh Todarbary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3870 5548
Email address
ntoodarbary@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Hypochlorite Sodium 0.005% versus placebo in treatment of mild to moderate Acne; A randomized double blind clinical control
Public title
Effect of Hypochlorite Sodium 0.005% in treatment of Acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild to moderate Acne Vulgaris diagnosed by dermatologist
Exclusion criteria:
Patients with symptoms such as secondary Acne caused by lactation
Dermatology condition in addition to Acne
Patients who had taken drugs such as Isotretinoin or systemic/topical antibiotics within the last two months
Allergy to Hypochlorite Sodium
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
We used block randomization method. Our sample includes 40 patients which was divided into 10 blocks with 4 patients in each one.
With random number table, our sample was divided into A and B groups and the data was written on the paper and randomizatin was done by random number table manually. Group A received Hypochlorite sodium 0.005% on the right side of their face and group B received that on the left side of their face; concurrently, group A received placebo on the left side of their face and group B received that on the right side of their face.
Blinding (investigator's opinion)
Double blinded
Blinding description
Although Hypochlorite Sodium and placebo(distilled water) were both put into the same white bottles; each bottle has specific code showing its content. Only the pharmacist is aware about these codes. During study, both dermatologist and patients were blind about using Hypochlorite sodium and placebo on each side of patients' faces.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
School medicine of Shiraz, Emam Hosein Square, Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2018-12-31, 1397/10/10
Ethics committee reference number
IR.SUMS.MED.REC.1397.413
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
Evaluation of Acne remission on the basis of changes in the number of Papules and Pustules
Timepoint
Initiation of study(before starting the treatment), 14 days and 28 days after starting the treatment
Method of measurement
Counting the number of Papules and Pustules
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Solution of Hypochlorite sodium 0.005% was prepared by pharmacist from Hypochlorite sodium 6%. In this study, the concentration of solution was determined according to the formulation used in previous studies. On the other hand, higher concentrations increase the possibility of skin damage. Although Hypochlorite sodium and placebo(distilled water) were both put into the same white bottles; each bottle has specific code showing its content. Only the pharmacist is aware about these codes. The patients received Hypochlorite sodium 0.005% administered topically on the right or left side of their face three times a day for one month. Hypochlorite sodium 0.005% was applied randomly on each side of the patients' faces. The patients were not aware of the type of solution (placebo or Hypochlorite sodium 0.005%) applied for them.In addition to patients, dermatologist and the recorder person were both blind about the solution applied for each side of patient's face.
Category
Treatment - Drugs
2
Description
Control group: The patients received placebo(distilled water)administered topically on the right or left side of their faces three times a day for one month.The placebo was applied randomly on each side of the patients' faces. The patients were not aware of the type of solution (placebo or Hypochlorite sodium 0.005%) applied for them.In addition to patients, dermatologist and the recorder person were both blind about the solution applied for each side of patient's face.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi hospital
Full name of responsible person
Azadeh Dorostkar
Street address
Next to the School medicine of Shiraz, Emam Hosein Square, Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
faghihihsp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Ghahartars
Street address
School medicine of Shiraz, Emam Hosein Square, Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5886
Email
mghahar@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?