Evaluaion of tolerability and efficacy of Melatrance lightening cream for the treatment of mild to moderate melasma
Design
Single group, phase 2, before -after clinical study. sample size is 19. The study is not randomized.
Settings and conduct
he study will be performed in Center for the Study and Research of Diseases of the Skin and Leprosy, 20 Cases of mild to moderate melasma will be selected and enrolled in the study after signing consent form. Volunteers will be taught to use Melatrance lightening cream for 12 weeks, twice in a day. Before intervention and 6 and 12 weeks after using changing in modified melasma severity index(mMASI), skin melanin content, size and amount of skin spots will be measured. This study is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
18 - 50 years old men and women, Cases of mild to moderate melasma (MGSC=1& 2), General health, Signing the consent form for participation in the study
Exclusion criteria:
Documented allergies to components of cream, Use of topical lightening products like AHA ,BHA and retinoid component within 21 days prior to the study, Pregnancy or lactating
Intervention groups
Using Melatrance lightening cream(Contains Tranexamic acid, Carica papaya, Psidium guajava, saxifragaceae and Pisum sativum)produced by Knowledge-based company of Janus on patient with mild to moderate melasma twice in a day for 12 weeks.
Main outcome variables
modified melasma severity index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042676N25
Registration date:2022-07-07, 1401/04/16
Registration timing:prospective
Last update:2022-07-07, 1401/04/16
Update count:0
Registration date
2022-07-07, 1401/04/16
Registrant information
Name
Aniseh Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 2220
Email address
a_samadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluaion of tolerability and efficacy of Melatrance lightening cream for the treatment of mild to moderate melasma
Public title
Evaluaion of tolerability and efficacy of Melatrance lightening cream for the treatment of melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 - 50 years old men and women
Cases of mild to moderate melasma (MGSC=1& 2)
General health
Signing the consent form for participation in the study
Exclusion criteria:
Documented allergies to components of cream
Use of topical lightening products like AHA ,BHA and retinoid component within 21 days prior to the study
Pregnancy or lactating
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 in research of medical school-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
2022-06-21, 1401/03/31
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.233
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, 6 weeks later and 12 weeks after intervention
Method of measurement
Using mMASI index
Secondary outcomes
1
Description
Skin melanin content changes
Timepoint
Before intervention,6 and 12 weeks after using
Method of measurement
mexameter
2
Description
Size and amount of skin spots
Timepoint
Before intervention, 6 and 12 weeks after using
Method of measurement
Visio face
Intervention groups
1
Description
Intervention group: Using Melatrance lightening cream(Contains Tranexamic acid, Carica papaya, Psidium guajava, saxifragaceae and Pisum sativum)produced by Knowledge-based company of Janus on patient with mild to moderate melasma twice in a day for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy