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CTRI Number  CTRI/2022/12/048073 [Registered on: 13/12/2022] Trial Registered Prospectively
Last Modified On: 24/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   Comparative, non-randomized study for keratosis pilaris (A condition that causes rough patches and small, acne-like bumps on the skin) 
Scientific Title of Study   Comparative study of efficacy of 2940 nm fractional Erb:yag vs 1064nm Nd:yag (FRAC3) vs both in the treatment of keratosis pilaris 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CACS-TRI-004, Version.1, dated 18 Oct 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Madura C 
Designation  Lead Consultant Dermatosurgeon Hair Transplantation Surgeon 
Affiliation  CUTIS Academy of Cutaneous Sciences 
Address  Department of Dermatosurgery Room No 10
5/1 4th Main MRCR Layout Vijayanagar Bangalore
Bangalore
KARNATAKA
560040
India 
Phone  9632741998   
Fax    
Email  maduradr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Madura C 
Designation  Lead Consultant Dermatosurgeon Hair Transplantation Surgeon 
Affiliation  CUTIS Academy of Cutaneous Sciences 
Address  Department of Dermatosurgery Room No 10
5/1 4th Main MRCR Layout Vijayanagar Bangalore
Bangalore
KARNATAKA
560040
India 
Phone  9632741998   
Fax    
Email  maduradr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Madura C 
Designation  Lead Consultant Dermatosurgeon Hair Transplantation Surgeon 
Affiliation  CUTIS Academy of Cutaneous Sciences 
Address  Department of Dermatosurgery Room No 10
5/1 4th Main MRCR Layout Vijayanagar Bangalore
Bangalore
KARNATAKA
560040
India 
Phone  9632741998   
Fax    
Email  maduradr@gmail.com  
 
Source of Monetary or Material Support  
CUTIS Academy of Cutaneous Sciens 5/1,4th Main, MRCR layout, Vijayanagar, bangalore 560040 
 
Primary Sponsor  
Name  NA 
Address  Na 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sunaina  CUTIS Academy of Cutaneous Sciences  Department of Dermatosurgery Room No 10 5/1,4th Main, MRCR layout, Vijayanagar, bangalore
Bangalore
KARNATAKA 		 9573828707

sunainasheikh18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CUTIS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L739||Follicular disorder, unspecified, (2) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  FRAC3 Nd: YAG 1064nm  Parameters - 25J/cm2, pulse width 1.6msec, spot size 6mm, single pass. 
Intervention  Fractional Erbium : YAG 2940nm  Parameters - 4-6J/cm2, spot size 4mm, frequency 8Hz, single pass. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age >18 years presenting with KP lesions 
 
ExclusionCriteria 
Details  •Patients on topical treatment (steroids, keratolytics, retinoids) 1 month before the laser treatment
•Patients who received laser for the treatment of keratosis Pilaris in the last 6 months.
•History of autoimmune disease
•History of Keloid & hypertrophic scar.
•Pregnant or lactating women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the effectiveness of Fractional Erbium: YAG laser, FRAC3 Nd: YAG laser and combination of both in the improvement of skin roughness, reduction of pigmentation and redness.  Baseline(week 0), week 4, week8, week 12 and week 16 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the patient satisfaction regarding the treatment response with respect to Fractional Erbium : YAG , FRAC3 Nd: YAG and combination of both lasers.  baseline(week 0) and week 16 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/12/2022 
Date of Study Completion (India) 20/12/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/05/2023 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

•      Keratosis pilaris is a common follicular keratinization disorder.

•      Characterized by follicular papules and perifollicular erythema.

•      It typically presents as symmetric, asymptomatic eruption predominantly on the extensor aspects of the proximal parts of the limbs but may involve the face, buttocks and trunk.

•      Often, the condition is inherited in an autosomal dominant manner.

•      The small papules impart a stippled appearance to the skin, resembling gooseflesh.

•      Its incidence is approximately 50% in adolescents and many patients undergo remission in adulthood.

•      This condition can be cosmetically very disturbing, especially in the teenagers or female patients.

•      There is no absolute cure for keratosis pilaris, but various treatment modalities reduce symptoms.

•      Emollients, keratolytic agents, topical retinoids can be used for treatment, but their efficacy is limited.

•      Recently, the effectiveness of laser treatments such as fractional CO2 laser, 810nm Diode laser, Q-switched Nd:YAG laser has been demonstrated.

•      In this study, we intend to compare the efficacy of Erb:YAG and FRAC3  Nd:YAG laser and combination of both, with regard to improvement in dyspigmentation and skin roughness in Keratosis Pilaris. 

 
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