Background: Melasma is a common acquired disorder characterized by symmetric,
hyperpigmented patches with an irregular outline, occurring most commonly on the face. The goal of this study was to evaluate the skin-lightening ability and tolerability profile of a novel formulation, cream solid lipid nanoparticles containing licorice extracts in the treatment of melasma. This study was, to our knowledge, the first to show the efficacy of this novel formulation in the treatment of melasma all over the world.
Methods: In this randomized, double-blinded and placebo-controlled clinical trial, 44 women patients with melasma clinically diagnosed referred to the Afzalipour hospital clinic were randomly divided into two treatment groups of 22 subjects each. All the patients were visited every four weeks from the beginning of the trial and evaluated MMASI score at 4, 8 and 12 weeks. The effectiveness of the treatment was classified in four levels as complete response, significant response, partial response and no response.
General information
Acronym
ELEOM
IRCT registration information
IRCT registration number:IRCT2016040316016N2
Registration date:2016-04-11, 1395/01/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-11, 1395/01/23
Registrant information
Name
Siavash Mohammadzadeh Shanehsaz
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1322 2251
Email address
siavash@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences, Deputy of research and technology
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Licorice extracts in the treatment of Melasma: randomized, double-blinded and placebo-controlled clinical trial
Public title
Effect of Licorice extracts in the treatment of Melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Patients with melasma clinically diagnosed 2- Women patients 3- Age between 20 to 40 years old 4- Patients with one lesion at least 5- Those don,t use any treatment for melasma during the six months prior to commencement of the study. Exclusion criteria: 1- Pregnant women 2- Lactating women 3- Those under treatment with other drugs for melasma during the six months prior to commencement of the study 4- Patients with history of allergy to licorice extracts 5- Treatment with oral contraceptives during of the study 6- Those under treatment with any drug for other diseases.
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences, Deputy of research and technology
Street address
Kerman
City
Kerman
Postal code
Approval date
2015-03-10, 1393/12/19
Ethics committee reference number
کا/93/293
Health conditions studied
1
Description of health condition studied
Melasma or Chloasma
ICD-10 code
L81.1
ICD-10 code description
Other disorders of pigmentation
Primary outcomes
1
Description
Size of lesions
Timepoint
Before and after intervention
Method of measurement
Examination
2
Description
Number of lesions
Timepoint
Before and after intervention
Method of measurement
Examination
3
Description
Location of lesions
Timepoint
Before intervention
Method of measurement
Examination
4
Description
Quality of life
Timepoint
Before and after intervention
Method of measurement
Questionare MELASQOL and DLQI
5
Description
Response to treatment
Timepoint
Before intervention and then at 4, 8 and 12 weeks
Method of measurement
Examination
6
Description
course of the disease
Timepoint
Before intervention
Method of measurement
Questionare
7
Description
Wood,s lamp examination
Timepoint
Before intervention
Method of measurement
Examination
Secondary outcomes
1
Description
Side effects
Timepoint
After intervention
Method of measurement
Examination
Intervention groups
1
Description
In intervention group: Treatment with cream of solid lipid nano particles containing licorice extracts 4%, BID (day and night) on the lesion along with cream sunscreen SPF=35
Category
Treatment - Drugs
2
Description
In control group: Treatment with cream placebo, BID (day and night) on lesion along with cream sunscreen SPF=35.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital, Kerman University of Medical Sciences
Full name of responsible person
Siavash Mohammadzadeh Shanehsaz
Street address
Kerman
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences, Deputy of research and technology
Full name of responsible person
Siavash Mohammadzadeh Shanehsaz
Street address
Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences, Deputy of research and technology
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
Kerman University of Medical Sciences
Full name of responsible person
Siavash Mohammadzadeh Shanehsaz
Position
Dermatology resident
Other areas of specialty/work
Street address
Kerman
City
Kerman
Postal code
Phone
+98 34 3325 7560
Fax
Email
mdsiavash@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Siavash Mohammadzadeh Shanehsaz
Position
Dermatology resident
Other areas of specialty/work
Street address
Kerman
City
Kerman
Postal code
Phone
+98 34 3325 7560
Fax
Email
mdsiavash@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Siavash Mohammadzadeh Shanehsaz
Position
Dermatology resident
Other areas of specialty/work
Street address
Kerman
City
Kerman
Postal code
Phone
+98 34 3325 7560
Fax
Email
mdsiavash@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)