| 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
|
|
|
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
|
|
|
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. |