Efficacy and safety assessment of a formulated topical cream containing Ginger for treatment of mild to moderate melasma
Design
parallel group, phase 3, treatment-control clinical study. sample size is 30.Randomization is done by random block method.
Settings and conduct
The study will be performed in Center for the Study and Research of Diseases of the Skin and Leprosy. 30 healthy volunteers will be selected and enrolled in the study after signing consent form.Individuals enter one of two intervention groups based on the randomization list (topical cream containing Ginger or 2% hydroquinone cream).Valenteers are taught to use the product assigned to the group for 12 weeks twice a day on their spots.At the end of weeks 6 and 12 as well as 3 months later , the severity of skin spots measured by mMASI.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Case 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, Active skin disease at test area: rosacea, atrophy, acne and eczema, Pregnancy or lactating, Use of systemic corticosteroid, isotretinoin within 28 days prior to the study, History of laser treatment or dermabrasion or deep facialpeels within the past 3 months
Intervention groups
Apply the topical cream containing Ginger and 2% hydroquinone cream as a control, for 12 weeks twice a day on the facial spots
Main outcome variables
modified melasma severity index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042676N8
Registration date:2020-05-31, 1399/03/11
Registration timing:prospective
Last update:2020-05-31, 1399/03/11
Update count:0
Registration date
2020-05-31, 1399/03/11
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
2020-07-05, 1399/04/15
Expected recruitment end date
2021-01-04, 1399/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety assessment of a formulated topical cream containing Ginger for treatment of mild to moderate melasma
Public title
Effect of anti-stain cream containing Ginger melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Active skin disease at test area: rosacea, atrophy, acne and eczema
Pregnancy or lactating
Use of systemic corticosteroid and isotretinoin within 28 days prior to the study
History of laser treatment or dermabrasion or deep facialpeels within the past 3 months
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Investigator
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
volunteers enter one of two intervention groups based on the randomization list (topical cream containing Ginger or 2% hydroquinone cream).Randomization is done by random block method. According to the random block method and considering the four blocks, 7 blocks will be produced for 28patients.
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessor doesn't know that each volunteer uses the control or studying cream
Placebo
Not used
Assignment
Parallel
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
2020-04-07, 1399/01/19
Ethics committee reference number
IR.TUMS.VCR.REC.1399.161
Health conditions studied
1
Description of health condition studied
melasma
ICD-10 code
L81.4
ICD-10 code description
Other melanin hyperpigmentation
Primary outcomes
1
Description
Modified melasma severity index
Timepoint
Before intervention, 6 and 12weeks after intervention and 3 months after stop using
Method of measurement
mMASI
Secondary outcomes
1
Description
Size and amount of skin spots
Timepoint
Before intervention, 6 and 12 weeks after using and 3 months after stop using
Method of measurement
Visio face
2
Description
Melanin content changes
Timepoint
Before intervention,6 and 12 weeks after using and 3 months after stop using
Method of measurement
mexameter
Intervention groups
1
Description
Intervention group: Approving a formulated topical cream containing Ginger on patient with mild to moderate melasma
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
center for research and training in skin diseases and leprosy