In the present study, we assay the effect of TCA (trichloroacetic acid) 33% on treatment of lip fissuring and cheilitis due to retinoids; the study has been designed single-blind randomized clinical trial. Inclusion criteria includes men and women aged 18 to 70 years; contact with other topical medications would be stopped two weeks before treatment; patients who sign informed consent; willing to participate in the study considering the visit requirements. Patients are divided in two groups of 37 people (Treatment) TCA (used four times within a month) and the other group (control) use Vaseline for a month. The patients who have a history of contact dermatitis to drugs; patients with acute localized infection; pregnant and lactating mothers; have OCD with digging lips habits; No satisfaction to participate at any stage of the study are excluded .The outcomes of survey are recovery rate after one month treatment according to physicians global score (0-5), satisfaction of patients according to patient global score (0-10).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201301169800N4
Registration date:2013-03-27, 1392/01/07
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-03-27, 1392/01/07
Registrant information
Name
Parvin Mansouri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6659 5911
Email address
mansorip@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Skin stem cell research center,Tehran University of Medical sciences
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2013-11-06, 1392/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of efficacy of TCA (TriChloroAcetic Acid) 33% in compression with placebo (vaseline) in the treatment of lip fissuring due to retinoids
Public title
The evaluation of efficacy of TCA (TriChloroAcetic Acid) 33% in the treatment of lip fissure due to retinoids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Patient age ranged from 18 to 70 years; contact with other topical medications would be stopped two weeks before treatment; patients who are able to read, understand and sign patient informed consent; Willing to participate in the study considering the visit requirements . Exclusion criteria: The patient had a history of contact dermatitis to the drugs; patients with acute localized infection; pregnant and lactating mothers; have OCD with digging lips habits; No satisfaction to participate at any stage of the study.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
37
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences and Health Services
Street address
Central administration of university, Ghodss St., Keshavarz Blvd
City
Tehran
Postal code
1417653761
Approval date
2012-11-17, 1391/08/27
Ethics committee reference number
91-03-150-19582-70437
Health conditions studied
1
Description of health condition studied
Lip fissuring
ICD-10 code
K13.0
ICD-10 code description
Diseases of lips
Primary outcomes
1
Description
Healing rate based on physicians global score (0-5) after one month treatment
Timepoint
Four session with weekly period
Method of measurement
Inspection & compare the photos by dermatologist before & after treatment
Secondary outcomes
1
Description
Patient satisfaction
Timepoint
Four session with weekly period
Method of measurement
Patient global score (0-10)
Intervention groups
1
Description
TCA usage, 4 times with weekly interval
Category
Treatment - Drugs
2
Description
Vaselin cream applying 1 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin clinic of Imam Khomeini hospital
Full name of responsible person
Dr. Parvin Mansouri
Street address
Imam Khomeini hospital, Kheshavarz Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Parvin Mansouri
Street address
Skin Ward, Imam Khomeini Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?