The aim of this study is to assess the efficacy and safety of Januluma cream for treatment of moderate to severe melasma in Iranian patients. It is a single arm, phase III clinical trial. 20 patients with melasma global severity score >2 recruited in the study. They are not allowed to use systemic corticosteroid and isotretinoin within past 28 days. Eligible subjects will receive Januluma cream once a day for four weeks. All subjects will be asked to return for follow-up 4 and 8 weeks after finishing the treatment. Digital photographs will be taken by VisioFace and subjects will be assessed for the Modified melasma severity index at baseline and follow-up visits. Also, Corneometer, TEWAmeter, Mexameter, Sebumeter, pH meter and ultrasonographic measurements will be determined at baseline and follow-up visits. Subjects will also rate overall satisfaction based on Visual Analogue scale (0-No satisfaction, 10- very much satisfaction) on both follow-up visits. Primary outcome will be change in Modified melasma severity index after 8 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121031288N2
Registration date:2017-04-07, 1396/01/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-07, 1396/01/18
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
Jarfandishan-e Navid-e Salamat (Janus) knowledge-based company
Expected recruitment start date
2016-12-20, 1395/09/30
Expected recruitment end date
2017-12-20, 1396/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety assessment of Januluma cream for treatment of moderate to severe melasma . A single arm, phase II clinical trial
Public title
Effect of whitening cream on melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion : Case of moderate to severe melasma (MGSC>2); age range 18-50 (men or women); signed informed consent voluntarily and knowingly Exclusion :pregnancy or lactation؛ use of systemic corticosteroid, isotretinoin within 28 days prior to the study; use any light sensitive drug within 3 months prior to the study؛ Active skin disease at test area: rosacea, atrophy, acne, eczema; Use of topical lightening products like AHA ,BHA and retinoid component within 21 days prior to the study; Documented allergies to components of Januluma cream؛ Use of contraceptive or any hormonal drugs؛ History of laser treatment or dermabrasion or deep facial peels within the past 3 months
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
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
Pharmaceutical Sciences Branch,Ethic committee of Islamic Azad University
Street address
Yakhchal street ,Gholhak,Tehran
City
Tehran
Postal code
19395-6466
Approval date
2016-05-17, 1395/02/28
Ethics committee reference number
IR.IAU.PS.REC.1395.13
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, one month later, two month after intervention
Method of measurement
mMASI
Secondary outcomes
1
Description
skin pH
Timepoint
before and after 4and 8 weeks
Method of measurement
MPA 580
2
Description
Skin sebum
Timepoint
Before and after 4and 8 weeks
Method of measurement
MPA 580
3
Description
Skin melanin and erythem
Timepoint
before and after 4 and 8 weeks
Method of measurement
MPA 580
4
Description
TEWL
Timepoint
before and after 4 and 8 weeks
Method of measurement
MPA 580
5
Description
Size and value of skin spot
Timepoint
before and after 4 and 8 weeks
Method of measurement
Visioface
Intervention groups
1
Description
Approving the Januluma whitening cream on patient with moderate to severe 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 Leprosy
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jarfandishan-e Navid-e Salamat (Janus) knowledge-based company
Full name of responsible person
Najva Kashani
Street address
No. 415, Taleqni Ave., Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jarfandishan-e Navid-e Salamat (Janus) knowledge-based company
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Center For Research And Training In Skin Diseases And Leprosy
Full name of responsible person
Saman Ahmad Nasrollahi
Position
assistant professor
Other areas of specialty/work
Street address
No. 415, Taleqni Ave., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8897 7921
Fax
Email
samannasrol@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical science
Full name of responsible person
Alireza firooz
Position
professor
Other areas of specialty/work
Street address
No. 415, Taleqni Ave., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8897 7921
Fax
Email
firozali@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic azad university of pharmaceutical science
Full name of responsible person
Maedeh Sabet
Position
student
Other areas of specialty/work
Street address
Yakhchal street - Islamic Azad University Of Pharmaceutical Sciences Branch
City
Tehran
Postal code
1941933111
Phone
+98 212264005155
Fax
+98 21 2260 0099
Email
maedesabet@yahoo.com
Web page address
www.fa.iaups.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)