| CTRI Number |
CTRI/2024/04/066391 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Assessing Enzyme Boosters Efficacy in Androgenetic Alopecia (AGA) An Open-label Single-arm Study |
|
Scientific Title of Study
|
A single-blinded prospective study to assess the efficacy of Sulfotransfarase (SULT) enzyme boosters in limited and nonresponding patients of androgenetic alopecia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CACS (23-24)-010, Version:1 dated: 07 Nov 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Megha C |
| Designation |
Consultant Dermatologist and HOD.of Trichologist |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Room No:19
Department of Trichology
5/1,4th Main, MRCR Layout, Vijayanagar
Bangalore
KARNATAKA
560040
India |
| Phone |
8095196167 |
| Fax |
|
| Email |
drmeghacs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Megha C |
| Designation |
Consultant Dermatologist and HOD.of Trichologist |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Room No:19
Department of Trichology
5/1,4th Main, MRCR Layout, Vijayanagar
KARNATAKA
560040
India |
| Phone |
8095196167 |
| Fax |
|
| Email |
drmeghacs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Megha C |
| Designation |
Consultant Dermatologist and HOD.of Trichologist |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Room No:19
Department of Trichology
5/1,4th Main, MRCR Layout, Vijayanagar
KARNATAKA
560040
India |
| Phone |
8095196167 |
| Fax |
|
| Email |
drmeghacs@gmail.com |
|
|
Source of Monetary or Material Support
|
| CUTIS Academy of Cutaneous Sciences Department of Trichology Room No:19 5/1,4th Main, MRCR Layout Vijayanagar, Bangalore Karntaka, India 560040 |
|
|
Primary Sponsor
|
| Name |
CUTIS Academy of Cutaneous Sciences |
| Address |
Room No:19 Department of Trichology
5/1,4th Main, MRCR Layout, Vijayanagar
Bangalore
KARNATAKA
560040
India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Brinda G |
CUTIS Academy of Cutaneous Sciences |
Room No:19
Department of Trichology
5/1,4th Main, MRCR Layout, Vijayanagar
Bangalore
KARNATAKA |
7842033275
brinda.gunjepalli2@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 |
| Intervention |
Minoxidil booster |
To study efficacy of sulfotransferase (SULT) enzyme boosters in individuals with androgenetic alopecia (AGA) who have shown a limited or no response to minoxidil treatment.
Topical treatment
Trichoscopy evaluation will be done at every visit(baseline, week 4, Week 8, and Week 12) |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Male and Female patients, from 18-45 years of age
Androgenetic Alopecia (AGA) patients who had limited or no response to topical minoxidil
Participants who are able to provide a written informed consent and photo consent form
Participants who are willing to be clinically photographed as per protocol |
|
| ExclusionCriteria |
| Details |
Patient who is not willing to participate in the study.
Patients with scalp conditions like seborrheic dermatitis or drugs like low-dose aspirin or topical tretinoin interfering with the treatment response |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of the SULT enzyme boosters in non-responders and limited responders to minoxidil and evaluate the treatment outcome |
After 3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Global photography assessment will be concerning hair growth at every visit like baseline, week 4, Week 8, and Week 12: scale as follows: -2(moderately worse), -1(slightly worse), 0 (no change), +1 (slightly improved), and +2 (moderately improved).
Trichoscopic assessment done at every visit like baseline, week 4, Week 8, and Week 12 |
After 3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/05/2024 |
| Date of Study Completion (India) |
22/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 an excessive response
to androgens .The incidence approximates the age in Caucasian males, with 50%
affected by 50 years old and up to 80% affected by 70 years old.In the Indian context, a prevalence rate of 58%
in males aged 30–50 years has been found. In all cases, the incidence gradually
increases with age.
Minoxidil ,
Finasteride, the Hair Max Laser Comb are the only treatment options that is
approved by the FDA for androgenetic alopecia. Minoxidil
is the only topical drug approved by the US FDA to regrow hair1
Minoxidil is
a produrug, a potent arteriolar vasodilator that opens potassium channels
located on the smooth muscles of the peripheral artery, causing
hyperpolarization of the cell membrane.In
order to exert biological activity, minoxidil requires conversion to minoxidil sulfate by
sulfotransferase enzymes (SULT1A1). which
is located in hair follicles and varies in production among individuals. The patients with higher enzyme activity
responded better to topical minoxidil than those with lower enzyme activity.
Hypoxia is difficult to mimic in a
therapy; other mechanisms that would
affect similar regulatory pathways intersecting hypoxia and
sulfotransferase activity. One such
mechanism is intercellular pH 2Specifically, increased
sulfotransferase is a biomarker for keratinocyte differentiation3To
increase the pH of the follicular stem cells as a means of increasing sulfotransferase activity. Hence a novel
topical formula has been developed
The formula uses a liposomal encapsulated
alkalizing agent to change the pH of the ORS. The encapsulated chemistry
increase penetration of the alkalizing agent into the cells.2
In this study we intend to study the
efficacy of sulfenzyme booster in increasing the response to topical minoxidil
who are not responding or having limited response to minoxidil |