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CTRI Number  CTRI/2024/12/077733 [Registered on: 06/12/2024] Trial Registered Prospectively
Last Modified On: 02/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Use of Oral isotretinoin on wound healing in hair transplanted patients 
Scientific Title of Study   Oral isotretinoin in hair transplant patients and its effect on wound healing 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CACS-PD-030, Version:1, Dated 16 Oct 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Madura C 
Designation  Medical Director and Chief Hair transplant Dermatosurgeon 
Affiliation  CUTIS Academy of Cutaneous Sciences 
Address  Department of Dermatosurgery Rooma 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  Medical Director and Chief Hair transplant Dermatosurgeon 
Affiliation  CUTIS Academy of Cutaneous Sciences 
Address  Department of Dermatosurgery Rooma No: 10
5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore

KARNATAKA
560040
India 
Phone  9632741998  
Fax    
Email  maduradr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Madura C 
Designation  Medical Director and Chief Hair transplant Dermatosurgeon 
Affiliation  CUTIS Academy of Cutaneous Sciences 
Address  Department of Dermatosurgery Rooma No: 10
5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore

KARNATAKA
560040
India 
Phone  9632741998  
Fax    
Email  maduradr@gmail.com  
 
Source of Monetary or Material Support  
CUTIS Academy of Cutaneous Sciences 5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore 560040 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 Madura C  CUTIS Academy of Cutaneous Sciences  Department of Dermatosurgery Room No:10 5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore 560040
Bangalore
KARNATAKA 
9632741998

maduradr@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: L649||Androgenic alopecia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  No Oral isotretinoin (Control)  Group B will not receive any isotretinoin treatment (Control Group) 
Intervention  ORAL ISOTRETINOIN  Group A will receive oral isotretinoin at a dose of 0.5 mg once daily starting 1 month prior to the procedure and will be continued for 6 months 
 
Inclusion Criteria  
Age From  23.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Androgenetic alopecia patients undergoing hair transplant procedure.
2.Age group 23 to 50 years of both the genders.
3.Patients having seborrheic scalp with history of itching, folliculitis or pustules on the scalp. 
 
ExclusionCriteria 
Details  1.History of allergic reaction to the drug.
2.Presence of any contraindication to isotretinoin like psychiatric disorders, pseudotumor cerebri, pancreatitis, hyperlipidemic conditions, hearing impairment, inflammatory bowel diseases, vision impairment.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To investigate the potential positive effects of oral isotretinoin on wound healing in hair transplant patients.  After 6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the impact of isotretinoin on post-hair transplant graft survival, scar quality of donor and recipient area, and patient satisfaction.  After 6 Months 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   17/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Androgenetic alopecia is a genetically predetermined disorder due to excessive response to androgens, impacting approximately 50% of males and females.[1,2,3,]FDA approved treatments include minoxidil, finasteride and LLLT[4]

For many, medical treatment alone does not provide desired results and surgical treatment of AGA has gained popularity over the past several decades. Today the most widely used technique is micrografting by the follicular unit extraction method. This outpatient procedure requires a great deal of technical skill and endurance on the part of the surgeon. [5,6]

Hair transplantation is a relatively safe surgery and is associated with very few complications. It is a cosmetic surgery so the complications may impact social and psychological aspect of the patient. Folliculitis after hair transplant surgery is a common complication with potentially multiple etiologies. Chronic lesions of superficial folliculitis may develop into deep folliculitis, and conversely, severe postoperative folliculitis may lead to cellulitis or furunculosis, which can result in scarring and hair loss.[7]

Isotretinoin (13-cis-retinoic acid) is a retinoid derivative of vitamin A approved by the FDA of the United States and Europe (excluding Sweden) in 1982 and 1983, respectively. Its primary use is for treating severe recalcitrant cases of acne vulgaris.[8] It works by reducing the size of sebaceous glands, lowering sebum excretion, regulating cell proliferation, and decreasing keratinization. Isotretinoin can alter the microenvironment of the follicles, resulting in a decrease in the number of Cutibacterium acnes. [9,10] Additionally, it possesses anti-inflammatory and immunomodulatory properties by reducing monocyte TLR-2 expression, minimizing the inflammatory cytokine response, and antineoplastic properties, making it a valuable treatment option for various skin diseases. [11,12]

Isotretinoin due to its multiple action of  inhibition of the lipid production of the sebaceous glands, while having a direct inhibitory effect on the immune system. It reduces the expression of different matrix-metalloproteinases and therefore inhibits the migration of neutrophils into the skin. [13] Furthermore, it leads to a decrease in expression of toll-like receptor 2, which mediates the immune response to Gram-positive bacteria. [14]

Research is needed to determine the effectiveness of oral isotretinoin for hair transplant patients, preventing post hair transplant complications and have a beneficial effect on wound healing post procedure. There is a paucity of data about the effectiveness of oral isotretinoin as a preventive measure to reduce complications in hair transplant cases which prompted us to do this study.

 
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