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Evaluation of safety and efficacy of Nanostructured lipid carrier( NLC) nanoparticles containing hydroquinone, tretinoin, and fluocinolone compared with conventional formulation in the treatment of melasma

Protocol summary

Study aim
Evaluation the effectiveness of cream containing hydroquinone, tretinoin and fluocinolone nanoparticles and its comparison with the normal form of the cream
Design
Clinical trial, one parallel group, two blinded side, phase 2 in 20 people
Settings and conduct
The study is a parallel evaluation of Nanostructured lipid carrier( NLC) nanoparticles containing hydroquinone, tretinoin, and fluocinolone compared with conventional formulation in the treatment of melasma in Center For Research and Training in skin Diseases and Leprosy
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women or men 18 to 50 years old, patients with almost symmetrical melasma on both sides of the face mild to moderate (at least grade 2 MGSC), no local and systemic treatment for melasma during the last 4 weeks, Appropriate health status, no change in life style during the study, Exclusion criteria: Pregnant or those who intend to become pregnant during the study, individuals with known allergies to any of the components of cream, history of topical use of any of corticosteroids, retinoid compounds, Chemical peels, compounds AHA and BHA in the last 21 days, History of systemic use of corticosteroids, tretinoin compounds, interferon types in the last 28 days, patients with rosacea acne, skin atrophy, acne and eczema, history of using drugs that increase photosensitivity in past 3 months, people who have had laser or microdermabrasion of the skin in the last 3 months, unsuitable to volunteer for the study if their doctor determines for some reasons
Intervention groups
An intervention group consisted of 20 men or women in the age range of 18 to 50 years with almost symmetrical facial melasma who were given two tubes of cream and randomly used each of these tubes on one side of their face. We observe the changes after 4 and 8 weeks.
Main outcome variables
modified melasma severity index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161207031288N13
Registration date: 2022-07-11, 1401/04/20
Registration timing: prospective

Last update: 2022-07-11, 1401/04/20
Update count: 0
Registration date
2022-07-11, 1401/04/20
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
2022-07-23, 1401/05/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and efficacy of Nanostructured lipid carrier( NLC) nanoparticles containing hydroquinone, tretinoin, and fluocinolone compared with conventional formulation in the treatment of melasma
Public title
Evaluation of NLC nanoparticles containing hydroquinone, tretinoin, and fluocinolone in the treatment of melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 - 50 years old men and women Case of approximately symmetrical moderate to severe melasma (melasma global severity score(MGSC)>2) No topical and systemic treatment for melasma during the last 4 weeks Appropriate general health condition No change in life style during the study Signing the consent form of the candidate to participate in the study and the desire to attend regular follow-up courses
Exclusion criteria:
Pregnant people or those who plan to become pregnant during the study People with known allergies to any of the components of the cream History of using each of the mentioned compounds topically in the last 21 days: Corticosteroids, retinoid compounds, chemical peels, alpha hydroxy acid and beta hydroxy acid compounds History of systemic use of each of the mentioned compounds in the last 28 days: corticosteroids, tretinoin compounds, interferon types Patients with rosacea, skin atrophy, acne and eczema History of use of drugs that increase photosensitivity in the last 3 months People who have had laser skin peeling or microdermabrasion in the last 3 months If the doctor of the study determines that the volunteer is not appropriate for this study by some reaons
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 20
More than 1 sample in each individual
Number of samples in each individual: 2
According to the random table, each patient is randomly told to apply cream A to the left and cream B to the right of the face or vice versa.
Randomization (investigator's opinion)
Randomized
Randomization description
Each patient with melasma is given two prepared creams in the form of identical packages coded as A and B. The evaluating physician and the patient are both unaware of the ingredients in the two creams. Cream A is said to be rubbed to the left and cream B to the right of the face or vice versa
Blinding (investigator's opinion)
Double blinded
Blinding description
Evaluating physician and the patient are both unaware of the ingredients in the two creams
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
2021-03-07, 1399/12/17
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.1228

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
Using mMASI(modified Melasma Severity Index)

Secondary outcomes

1

Description
skin pH
Timepoint
Before intervention, 4 weeks later, 8 weeks after intervention
Method of measurement
MPA 580

2

Description
Skin sebum
Timepoint
Before intervention, 4 weeks later, 8 weeks after intervention
Method of measurement
MPA 580

3

Description
Skin melanin and erythem
Timepoint
Before intervention, 4 weeks later, 8 weeks after intervention
Method of measurement
MPA 580

4

Description
Trance Epidermal Water Lost (TEWL)
Timepoint
Before intervention, 4 weeks later, 8 weeks after intervention
Method of measurement
MPA 580

5

Description
Size and value of skin spot
Timepoint
Before intervention, 4 weeks later, 8 weeks after intervention
Method of measurement
Visio face

Intervention groups

1

Description
Intervention group: use of Nanostructured lipid carrier( NLC) nanoparticles containing hydroquinone, tretinoin and fluosinolone made in lab, in patients with moderate to severe melasma in one side of patient's face once in a day for 8 weeks
Category
Treatment - Drugs

2

Description
Control group: use of commercial formulations containing hydroquinone, tretinoin and fluosinolone made by Janus pharma company, in patients with moderate to severe melasma on one side of the patient's face once in a day for 8 weeks
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
Shaghayegh Afzali
Street address
No. 415, Shahid Naderi Street, Taleqani Avnue
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8896 0880
Fax
+98 21 8896 3804
Email
dermalab@sina.tums.ac.ir
Web page address
https://crtsdl.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotoohi
Street address
Tehran University of Medical Sciences, 16 Azar St., Enghelab Square
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۱
Phone
Email
pharmacy@tums.ac.ir
Web page address
https://pharmacy.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Tehran University of Medical Sciences
Full name of responsible person
Saman Ahmad Nasrollahi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No. 415, Taleqni Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
0098 21 8897 792
Email
samannasrol@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza firooz
Position
Proffesor of Dermatology
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No. 415, Taleqni Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
098 21 8897 7921
Email
firozali@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shaghayegh afzali
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Tehranpars, 3rd Square, between Bagheri and Ordibehesht Highways, Shahid Ghazaghi St., Babam Mohammadi St.
City
Tehran
Province
Tehran
Postal code
1686994631
Phone
+98 21 7737 8922
Email
shaghayeghafzali266@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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