The present study has been done to compare efficiency and side effects of Trichloroacetic Acid (TCA) 35% with cryotherapy in the treatment of solar lentigo. This study was a randomized clinical trial performed on 35 individuals suffering from solar lentigo on their hands. At first, images were taken from both hands, and then one side was treated with cryotherapy and the other side with TCA 35%. The treatment was repeated after one month. The imaging was repeated at the end of the second month and both sides were compared with previous images considering degree of improvement (lightening) of lesions and the resulted side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904084269N1
Registration date:2010-10-09, 1389/07/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-10-09, 1389/07/17
Registrant information
Name
Farideh Golfroushan
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1541 2101
Email address
golfroushanf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice-chancellor of Tabriz University of Medical Sciences
Expected recruitment start date
2008-10-15, 1387/07/24
Expected recruitment end date
2009-10-16, 1388/07/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and Side Effects of Trichloroacetic Acid (TCA) versus Cryotherapy in the Treatment of Solar Lentigo
Public title
Efficacy of Chemical peeling versus Cryotherapy in the Treatment of Solar Lentigo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: solar lentigo of face or hand
Exclusion criteria: wart, recurrent herpes, sensitivity to light, raynaud phenomenon, pregnancy, lactation, sunburn within recent 2-3 days, those who have received treatments such as surgery, cryotherapy, radiotherapy or PUVA therapy within the last 6 weeks or Isotretinoin during last 6 months
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences,Tabriz, Iran
City
Tabriz
Postal code
Approval date
empty
Ethics committee reference number
887
Health conditions studied
1
Description of health condition studied
Solar lentigo
ICD-10 code
L81.4
ICD-10 code description
other melanin hyperpigmentation
Primary outcomes
1
Description
Lightening of lesions
Timepoint
2 months after treatment
Method of measurement
clinical
Secondary outcomes
1
Description
Side effects: Permanent & severe pain, Blister, Permanent erythema & edema, hyperpigmentation, hypopigmentation, scar
Timepoint
Every month
Method of measurement
clinical
Intervention groups
1
Description
After washing with water and soap, the lesion was treated with TCA 35% with a cotton applicator
Category
Treatment - Drugs
2
Description
Cryotherapy spray for one time so that tip of the spray had a 3-centimeter distance with the lesion and spraying was continued until surface of the lesion became frosted as a result of spraying. Duration of spraying varied from 2 to 5 seconds regarding diameter of the lesion.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Educational and Therapeutic Center of Tabriz
Full name of responsible person
Dr. Farideh golfroushan
Street address
Dermatology Word, Sina Hospital, Azadi St., Tabriz,
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice-chancellor of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Rasoul Azarfarin
Street address
Research Vice-chancellor, Tabriz University of Medical Sciences,
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice-chancellor of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farideh Golfroushan
Position
Assistant Professor of Dermatology
Other areas of specialty/work
Street address
Dermatology Word, Sina Hospital, Azadi St., Tabriz,
City
Tabriz
Postal code
Phone
+98 914 315 5647
Fax
Email
Dr_fGolfroushan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farideh Golfroushan
Position
Assistant Professor of Dermatology
Other areas of specialty/work
Street address
Dermatology Word, Sina Hospital, Azadi St., Tabriz,
City
Tabriz
Postal code
Phone
+98 914 315 5647
Fax
Email
Dr_fGolfroushan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Sadeghi
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Dermatology Word, Sina Hospital, Azadi St., Tabriz,
City
Tabriz
Postal code
Phone
Fax
Email
Mohsad_1357@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)