Evaluate the efficacy of nano lipid carrier drug delivery system containing tretinoin
Design
In this study, 20 patients with moderate to severe acne with entry requirements referring to the center of the skin and leprosy are selected. In these participants, one side of the face is selected for use of the nano-lipid tretinoin and the opposite side for the typical cream of tretinoin.
Settings and conduct
the study conducted on all patients with moderate to severe acne vulgaris referred to the center of research and training in skin diseases and leprosy. the study was a randomized parallel single blind (patient) study. patients in both treatment groups will use topical formulation with similar physical appearance and packaging.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Aged between 12 to 40 years
10 -50 acne lesions
No change in diet and life style during the study
Signed informed consent voluntarily and knowingly
Exclusion criteria
Long-time exposure to UV radiation
History of sensitivity to topical anti acne drug therapy
Use of topical anti acne drug therapy including AHA, BHA, benzyl peroxide, vitamin A, retin-A, antibiotics within one month prior to the study
Pregnancy / breastfeeding
History of systemic antibiotics for acne treatment within one month prior to the study
Intervention groups
Rubbing nano lipid of tretinoin into the acne lesions on one side of the face once a day for 8 weeks.
Control:Rubbing the tretinoin cream into the lesions area on the opposite face once a day for 8 weeks
Main outcome variables
Evaluation of the improvement of based on the Global Acne Grading System with comparison of the photos taken from the location of the lesions at zero time and then at 4th and 8th weeks after treatment. Secondary outcome: (a) local dry skin through physical examination at 4th and 8th weeks after treatment; (b) local erythema through physical examination at 4th and 8th weeks after treatment; (c) local skin irritation through taking history of the patient at 4th and 8th weeks after treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161207031288N2
Registration date:2018-01-03, 1396/10/13
Registration timing:retrospective
Last update:2018-01-03, 1396/10/13
Update count:0
Registration date
2018-01-03, 1396/10/13
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
2017-06-03, 1396/03/13
Expected recruitment end date
2017-10-29, 1396/08/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the efficacy of nano lipid carrier drug delivery system containing tretinoin
Public title
Effect of tretinoin nano lipid on acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Aged between 12 to 40 years
2. 10 -50 acne lesions
3. No change in diet and life style during the study
4. Signed informed consent voluntarily and knowingly
Exclusion criteria:
Long-time exposure to UV radiation
History of sensitivity to topical anti acne drug therapy
Use of topical anti acne drug therapy including AHA, BHA, benzyl peroxide, vitamin A, retin-A, antibiotics within one month prior to the study
Pregnancy / breastfeeding
History of systemic antibiotics for acne treatment within one month prior to the study
Age
From 12 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
By using the random numbers table
Blinding (investigator's opinion)
Single blinded
Blinding description
the study was a randomized parallel single blind (patient) study. patients in both treatment groups will use topical formulation with similar physical appearance and packaging.
Placebo
Not used
Assignment
Parallel
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 - Islamic Azad University Of Pharmaceutical Sciences Branch
City
Tehran
Province
Tehran
Postal code
19395-6466
Approval date
2016-01-30, 1394/11/10
Ethics committee reference number
IR.TUMS.REC.1394.1771
Health conditions studied
1
Description of health condition studied
acne
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
Modified acne severity index
Timepoint
Beforeintervention, one mouthlater ,two mounth after intervention
Method of measurement
MPA580
Secondary outcomes
1
Description
Skin PH
Timepoint
Before and after 4 and 8 weeks
Method of measurement
MPA580
2
Description
Skin sebum
Timepoint
Before and after 4 and 8 weeks
Method of measurement
MPA580
3
Description
Skin melanin and erythem
Timepoint
Before and after 4 and 8 weeks
Method of measurement
MPA580
4
Description
Transepidermal water loss
Timepoint
Before and after 4 and 8 weeks
Method of measurement
MPA580
5
Description
Hydration
Timepoint
Before and after 4 and 8 weeks
Method of measurement
MPA580
6
Description
Size and value of acne
Timepoint
Before and after 4 and 8 weeks
Method of measurement
Visiopor
Intervention groups
1
Description
Intervention group: Administration of tretinoin Nanolipid in Patients with Moderate to Severe Acne
Category
Treatment - Surgery
2
Description
Control group: Administration of tretinoin Cream in Patients with Moderate to Severe Acne
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for Research and Training in skin Diseases and Laprosy
Full name of responsible person
Saman Ahmad Nasrollahi
Street address
415,Taleghani Ave,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 7921
Email
samannasrol@gmail.com
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
Province
Tehran
Postal code
1416613675
Email
samannasrol@gmail.com
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
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
Center For Research And Training In Skin Diseases And Leprosy
Full name of responsible person
Saman Ahmad Nasrollahi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 415, Taleqni Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 7921
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
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Dermatology
Street address
No. 415, Taleqni Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 7921
Email
firozali@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic azad university of pharmaceutical science
Full name of responsible person
Zohre Sartipi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Yakhchal street - Islamic Azad University Of Pharmaceutical Sciences Branch
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 212264005155
Fax
Email
zohre.sartipi@yahoo.com
Web page address
http://fa.iaups.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available