Effect of Phytochemical and skin lightening of herbal formulation of Punica granatum and Crocus sativus versus Azelaic acid cream in patients with post inflammatory hyperpigmentation: a double-blind randomized clinical trial
To assess the effect of Phytochemical and skin lightening of herbal formulation of Punica granatum and Crocus sativus versus Azelaic acid cream in patients with post inflammatory hyperpigmentation
Design
This is a double-blind randomized clinical trial with control group, phase III, in which right and left side of the eligible patients will be randomly assigned through the drawing of lots to the intervention and control groups
Settings and conduct
This study will be performed in the Sina Hospital in Hamadan city on 40 eligible patients. The patients will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be double-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 60 years;
Post-inflammatory hyperpigmentation.
Exclusion criteria:
Pregnancy or breastfeeding;
Having a skin disease;
Taking retinoid drugs in the last three months;
Taking contraceptive or anti-inflammatory or immunosuppressive drugs.
Intervention groups
Intervention group:
Herbal cream containing pomegranate and saffron extract on the left side of the face twice a day for 12 weeks
Control group:
Cream Azelaic acid 20% on the right side of the face twice a day for 12 weeks
Main outcome variables
Hyperpigmentation; side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N450
Registration date:2022-12-19, 1401/09/28
Registration timing:prospective
Last update:2022-12-19, 1401/09/28
Update count:0
Registration date
2022-12-19, 1401/09/28
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Phytochemical and skin lightening of herbal formulation of Punica granatum and Crocus sativus versus Azelaic acid cream in patients with post inflammatory hyperpigmentation: a double-blind randomized clinical trial
Public title
Effect of Phytochemical and skin lightening of herbal formulation of Punica granatum and Crocus sativus versus Azelaic acid cream in patients with post inflammatory hyperpigmentation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years
Post-inflammatory hyperpigmentation
Exclusion criteria:
Pregnancy or breastfeeding
Having a skin disease
Taking retinoid drugs in the last three months
Taking contraceptive or anti-inflammatory or immunosuppressive drugs
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the right and left sides of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "right" on one sheet and "left" on another. Then, by referring to every patient, one of the sheets will be randomly taken. According to whether the sheet is taken right or left is assigned to the intervention group and the other side to the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-12-03, 1401/09/12
Ethics committee reference number
IR.UMSHA.REC.1401.735
Health conditions studied
1
Description of health condition studied
Postinflammatory hyperpigmentation
ICD-10 code
L81.0
ICD-10 code description
Postinflammatory hyperpigmentation
Primary outcomes
1
Description
Improvement of hyperpigmentation signs
Timepoint
Before treatment and 4, 8 and 12 weeks after treatment
Method of measurement
Using post acne hyperpigmentation index (PAHPI)
Secondary outcomes
1
Description
Side effects (including dryness, redness or peeling of the skin at the site of application of the cream)
Timepoint
At weeks 4 and 12
Method of measurement
By taking a history
Intervention groups
1
Description
Intervention group: Herbal cream containing pomegranate and saffron extract on the left side of the face twice a day for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: Cream Azelaic acid 20% on the right side of the face twice a day for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Hamadan city
Full name of responsible person
Fatemeh Hamidbeigi
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
fh.moghadam1999@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Hamidbeigi
Position
Student of Pharmacology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
fh.moghadam1999@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Dara Dastan
Position
Pharmacologist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
d.dastan@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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