1) Objective: The aim of this study is comparison of efficacy between Ammonium lactate 14% and IPL and Ammonium lactate 14% alone on keratosis pilaris. 2) Design: This study is a randomized clinical trial. 3) Setting and conduct: The patients with keratosis pilaris in dermatology clinic will be randomly divided into two groups (25 in each one). 4) Intervention: After taking consent, one group receives topical Ammonium lactate 14% for 3 months and the other group receives IPL in addition to topical treatment, 3 times with a month interval starting from the end of first month. 5) Main outcome measures: improvement assessed by two independent dermatologists blinded to the randomization process and by means of serial photography. 6) Participants: Inclusion criteria: patients who don't tend to only longterm and topical treatment and they prefer laser treatment; no pregnancy and breastfeeding and consent to participate in the study. Exclusion criteria include irregular returns and sensitivity to Ammonium lactate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061428448N1
Registration date:2016-12-07, 1395/09/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-07, 1395/09/17
Registrant information
Name
Siamak Rahmani
Name of organization / entity
Isfahan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 31 3627 2548
Email address
siamakrahmani@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Isfahan University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparing the effect of ammonium lactate 14% and IPL versus ammonium lactate 14%-alone on keratosis pilaris
Public title
The effect of ammonium lactate 14% and IPL on keratosis pilaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:being afflicted with keratosis pilaris; patients who don't tend to only longterm and topical treatment and they prefer laser treatmen; no pregnancy and breast feeding and consent to participate in the study.
Exclusion criteria:sensitivity to Ammonium lactate; no regular visits and using cotreatments.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Using a table of random number, random sampling was conducted.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjarib street, Isfahan, Iran
City
Isfahan
Postal code
Approval date
2016-01-13, 1394/10/23
Ethics committee reference number
IR.MUI.REC.1394.3.760
Health conditions studied
1
Description of health condition studied
Keratosis pilaris
ICD-10 code
L85.8
ICD-10 code description
Other specified epidermal thickening
Primary outcomes
1
Description
Clinical improvment
Timepoint
Before, 1 month after final treatment and 2 month after final treatment
Method of measurement
Photography evaluation by two blinded dermatologist
Secondary outcomes
1
Description
Improvements Vas score
Timepoint
Before, 1 month after final treatment and 2 month after final treatment
Method of measurement
Question from patient
Intervention groups
1
Description
Control group receives topical ammonium lactate 14% making the company noreva twice a day used as a thin layer on the waste for 3 months.
Category
Treatment - Other
2
Description
In treatment group we done 3 IPL sessions with 4 weeks interval and also advised the patients to apply topical ammunium lactate 14% making the company noreva twice a day used as a thin layer on the waste for 3 months. the setting of IPL was: 530-1100nm wavelength, one pass, fluence of 14-16 J/cm2, and program of 14-18.