Atopic dermatitis, a chronic inflammatory disease, and itching of the skin. Studies have shown that patients with atopic dermatitis are deficient in Gamma Linolenic Acid (GLA)and Essential Fatly Acids(EFA) groups. Linola F manufactured by Dr. August Wolff is a cream containing 60% fat (structural fat rich in Linolenic acid ). This study is a Phase III clinical trial with one group of patients in Split Body Trial design with mild to moderate atopic dermatitis severity ( SCORAD below than 12) referred to the Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Theran, Iran. When patients are came to the clinic of the center, first they are evaluated by experts based on the inclusion and exclusion criteria (Visit 0),then for each patient two symmetrical lesions with the same intensity are selected and each lesion will be treated based on per-mutated block randomization of size 2, one lesion with Linola F® cream and the opposite side with routine moisturizing cream witch patients commonly have used. sample size is 25 patients, also evaluator and allocator of treatment are different persons. The aim of this study is to evaluate the efficacy of the Linola F® and its impact on the physiology of the patients skin with atopic dermatitis, in comparison with routine moisturizing products in an Iranian population.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062017994N1
Registration date:2016-08-04, 1395/05/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-04, 1395/05/14
Registrant information
Name
Mansour Shamsipour
Name of organization / entity
Clinical Trial Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6690 1205
Email address
shamsipour@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Sina Tejarat Pishgam® Company
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy of Linola F® Cream (Dr. August Wolf Co) on mild to moderate forms of atopic dermatitis
Public title
Linola F® on Skin Physiology of patients with atopic dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Case of Mild to moderate atopic dermatitis
Aged (>2) years old
At least 2 lesions on arms or legs with identical local SCORAD
Written Informed Consent
Having a negative pregnancy test
Willingness to actively participate in the study and to come to the scheduled visits respectively willingness of parents/legal guardians to actively participate in the study and to come to the scheduled visits
Willingness to discontinue the use of any conventional skin care products (e.g. creams, lotions, sunscreens) at the treatment areas of Linola F throughout the course of the study
Exclusion Criteria:
Pregnancy or lactation
Severe Atopic eczema (local SCORAD >12)
Drug addicts, alcoholics
One of the following serious illnesses, if not medicated: cardiovascular diseases, asthma, hypertension
Active skin disease at test area (except atopic dermatitis)
Moles, tattoos, scars, hairs, dark pigmentation etc. at the test area that could influence the investigation
Documented allergies to cosmetic products
History of HIV
History of Hepatitis C
History of Hepatitis B
Being involved in any other research project /clinical trial
Age
From 2 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University Of Medical Sciences(TUMS)
Street address
Tehran, Enghelab Ave., St. pour Sinai, Deputy of Science and Technology of Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2015-06-14, 1394/03/24
Ethics committee reference number
IR.TUMS.REC.1394.32
Health conditions studied
1
Description of health condition studied
Atopic dermatitis with mild to moderate sevirty (SCORAD below than 12))
ICD-10 code
L20
ICD-10 code description
Atopic dermatitis
Primary outcomes
1
Description
Trans Epidermal Water Loss(TEWL)
Timepoint
Visit 0, 2 week after Visit 0, 4 week after Visit 0
Method of measurement
MPA
2
Description
Corneometer
Timepoint
Visit 0, 2 week after Visit 0, 4 week after Visit 0
Method of measurement
MPA
Secondary outcomes
1
Description
SCORAD Measure
Timepoint
Visit 0, 2 week after Visit 0, 4 week after Visit 0