consideration of clinical safety and efficacy of topical formulation of polyphenolic extract of punica granatum on patients with mild to moderate forms of melasma
Assessment of safety and efficacy of a cream containing pomegranate peel extract on patients with mild to moderate melasma
Design
Clinical trial without control group, non-blinded and non-randomised in phase 2 on 20 patients.
Settings and conduct
The study would be done as before-after trial with prescription of a cream containing pomegranate peel extract on the skin of patients with mild to moderate melasma in Center for Research and Training in Skin Diseases And Leprosy
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mild to moderate melasma with minimum grade of
Melasma Area and Severity Index=1; Age range 18-50; signing consent form. Exclusion criteria: Pregnancy or lactation; Use of systemic corticosteroid or isotretinoin; using any light sensitizing medicine; Active skin disease at test area; Use of topical lightening products like beta hydroxy acid, alpha hydroxy acid and products containing retinoid; Documented allergies to components of cream؛ History of laser treatment or dermabrasion or deep facial peels
Intervention groups
Intervention group involves patients receiving cream containing pomegranate peel extract, who apply the cream on melasma areas, two times a day (morning and night).
Main outcome variables
Modified melasma severity index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161207031288N6
Registration date:2020-10-12, 1399/07/21
Registration timing:prospective
Last update:2020-10-12, 1399/07/21
Update count:0
Registration date
2020-10-12, 1399/07/21
Registrant information
Name
Saman Ahmad Nasrollahi
Name of organization / entity
Center for Research and Training in Skin Diseases and Leprosy Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 8190
Email address
snasrollahi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
consideration of clinical safety and efficacy of topical formulation of polyphenolic extract of punica granatum on patients with mild to moderate forms of melasma
Public title
Assessment of pomegranate whitening cream on melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mild to moderate melasma with minimum grade of Melasma area and severity index = 1
Age range 18-50
Signing consent form, voluntarily and knowingly
Exclusion criteria:
Pregnancy or lactation
Using oral corticosteroids or isotretinoin within 28 days prior to the study
Any active skin disease at test area including rosacea, eczema, atrophy, acne
Using any light sensitizing medicine within 3 months prior to the study
Use of topical lightening products like alpha hydroxy acid, beta hydroxy acid, and retinoid component within 21 days prior to the study
Documented allergy to components of the cream
History of laser treatment or dermabrasion or deep facial peeling within the past 3 months prior to the study
Using contraceptive or hormonal medicines
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Research and Technology Dept, 6th floor, Central Organization of the University, Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-12-31, 1398/10/10
Ethics committee reference number
IR.TUMS.VCR.REC.1398.763
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
modified melasma severity index
Timepoint
Before intervention, 4 weeks later, 8 weeks after intervention
Method of measurement
Modified Melasma Area and Severity Index
Secondary outcomes
1
Description
skin pH
Timepoint
At the beginning (before start of the intervention) and 4 and 8 weeks after start of the intervention
Method of measurement
Cutometer MPA 580
2
Description
Skin sebum
Timepoint
At the beginning (before start of the intervention) and 4 and 8 weeks after start of the intervention
Method of measurement
Cutometer MPA 580
3
Description
Skin melanin and erythem
Timepoint
At the beginning (before start of the intervention) and 4 and 8 weeks after start of the intervention
Method of measurement
Cutometer MPA 580
4
Description
Transepidermal watre loss
Timepoint
At the beginning (before start of the intervention) and 4 and 8 weeks after start of the intervention
Method of measurement
Cutometer MPA 580
5
Description
Size and value of skin spot
Timepoint
At the beginning (before start of the intervention) and 4 and 8 weeks after start of the intervention
Method of measurement
Visio face device
Intervention groups
1
Description
Intervention group: Approving the whitening cream on patient with mild to moderate melasma (single arm study)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for Research and Training in skin Diseases and Laprosy
Full name of responsible person
Saman Ahmad Nasrollahi
Street address
415, Taleghani Ave. ,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
samannasrol@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Ali Sahraeian
Street address
6th floor, Vice chancellor in research affairs, Qods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Center For Research And Training In Skin Diseases And Leprosy
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Whole data is publishable after making patients identity unrecognisable
When the data will become available and for how long
Beginning of access to data would be six months after publishing of data
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Any sort of application of data is allowed, except using for making medicine based on the research
From where data/document is obtainable
For accessing data refer to Dr. Mahdi Vazirian. Address: Faculty of Pharmacy, In fron ot Nosrat Ave., 16th Azar Ave., Keshavarz Blvd., Tehran, Iran.
What processes are involved for a request to access data/document
Sending an E. mail request (mehdivazirian@gmail.com) or in-person referring to mentioned address. Data would be presentable within one week after request.