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Study of clinical effects of solid lipid nanoparticles Isotretinoin in treatment of acne

Protocol summary

Summary
The purpose of this study is to determine the characteristics and clinical effects of solid lipid nanoparticles(SLN) containing Isotretinoin in treatment of acne and compare with the commercial gel of Isotretinoin(Isotrex). In this study, SLN prepare using different lipids and their characteristics are determined,then 30 patients with moderate acne, who have inclusion and exclusion criteria, are chosen. A group of patients(group1) were treated with Isotretinoin topical gel available in the market with Hydroalcoholic solution of clindamycin 2% for 8 weeks and another group(group2) were treated with topical SLN containingIsotretinoin with equal concentrations and 2% clindamycin solution for 8 weeks. Then count the number of inflammatory and non inflammatory lesions in the start of treatment, second, forth, sixth and eighth weeks and the report of recovery percent based on seven degree was done; 0=completely recovered, 1 = almost recovered (~ 90%), 2 = remarkable improvement (~ 75%), 3 = moderate improvement (~ 50%), 4 = poor recovery (~ 25%), 5 = No difference and 6 = became worse; that if the further improvement was more than 50% effective, reported. Also the sensitivity of prepared products and marketed form will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201203283862N9
Registration date: 2013-05-10, 1392/02/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-05-10, 1392/02/20
Registrant information
Name
Farahzad Jababri Azad
Name of organization / entity
Mashahd University of Medical Scineces
Country
Iran (Islamic Republic of)
Phone
+98 51 1843 6626
Email address
banihashemim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Nano Technology Research Center,Mashhad University of Medical Sciences
Expected recruitment start date
2011-07-23, 1390/05/01
Expected recruitment end date
2012-06-20, 1391/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of clinical effects of solid lipid nanoparticles Isotretinoin in treatment of acne
Public title
Evaluation of solid lipid nanoparticles containing Isotretinoin in treatment of acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Acne vulgaris patients with grade 2 and 3 base on Investigator Global Assessment; No receiving topical treatment of acne from 4 weeks before this regimen. exclusion criteria:Androgenic acne;Acne due to drugs or cosmetics; Adrenal or Hormonal disorders.
Age
From 13 years old to 30 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashad University of Medical Sciences
Street address
Central Building of Mashad University of Medical Sciences
City
Mashhad
Postal code
Approval date
2011-04-30, 1390/02/10
Ethics committee reference number
89940

Health conditions studied

1

Description of health condition studied
Acne Vulgaris
ICD-10 code
L70.0
ICD-10 code description
Acne

Primary outcomes

1

Description
inflammatory and non-inflamatory lesions
Timepoint
Biweekly after starting treatment
Method of measurement
Observation and calculating of elementary lesions based on photographic image

Secondary outcomes

1

Description
evaluation of side effects like skin irritation , erythema , skin dryness.pruritus
Timepoint
Biweekly
Method of measurement
Observation and severity scoring from + to +++

Intervention groups

1

Description
Control group: receiving of 0.05% isotretinoin gel ( isotrex); made in Irland. once a day for 8 weeks
Category
Treatment - Drugs

2

Description
Interventional group:receiving solid lipid nanoparticles (SLNs) containing 0.05% isotretinoin once a day for 8 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Quem Hospital, Department of Dermatology,research center for skin diseases and cutaneous leishmania
Full name of responsible person
Dr Pouran Layegh
Street address
Department of Dermatology, Qaem hospital, Ahmad Abad street.
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Nano Technology Research Center,Mashhad University of Medical Sciences
Full name of responsible person
Dr Shiva Golmohamadzadeh
Street address
Buali(Avicenna) research Institute, Buali square
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nano Technology Research Center,Mashhad University of Medical Sciences
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
Nano Technology Research Center and faculty of pharmacy
Full name of responsible person
Danial Bagheri
Position
students of pharmacy
Other areas of specialty/work
Street address
faculty of pharmacy
City
Mashhad
Postal code
Phone
+98 51 1882 3255
Fax
Email
bagherid851@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Pharmacy, Mashhad University of medical Sciences.
Full name of responsible person
Dr Shiva Golmohamadzadeh.
Position
Assistant professor
Other areas of specialty/work
Street address
Faculty of Pharmacy, Vakil Abad Blvd., Opposite Mellat park.
City
Mashhad
Postal code
Phone
+98 51 1711 2611
Fax
Email
golmohamadzadehsh@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Research center for skin diseases and cutaneous leishmaniasis
Full name of responsible person
Akram sadat Momenzadeh
Position
of sciences, biologist
Other areas of specialty/work
Street address
Research center for skin diseases and cutaneous leishmaniasis,office bulding, Ahmad abad street, Ghaem hospital.
City
Mashhad
Postal code
Phone
+98 51 1841 0135
Fax
Email
src@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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