| CTRI Number |
CTRI/2024/07/070432 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the Combined Effect of Tretinoin Gel 0.1% and Minoxidil 5% ( ST- Rich Duo) in Treating Androgenic Alopecia |
|
Scientific Title of Study
|
Assessment of Efficacy and Safety of ST-Richduo (Tretinoin gel 0.1% with topical minoxidil 5%) in the Treatment of Androgenic Alopecia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CACS-RML-001 Version & Date: 1.0 / 07 Jun 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B S Chandrashekar |
| Designation |
Chief Dermatologist and Managing Director |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Department of Dermatology
Room No 1
5/1 4th Main MRCR Layout
Vijayanagar Bangalore
Bangalore
KARNATAKA
560040
India |
| Phone |
9740091155 |
| Fax |
|
| Email |
cutisclinic@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B S Chandrashekar |
| Designation |
Chief Dermatologist and Managing Director |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Department of Dermatology
Room No 1
5/1 4th Main MRCR Layout
Vijayanagar Bangalore
KARNATAKA
560040
India |
| Phone |
9740091155 |
| Fax |
|
| Email |
cutisclinic@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B S Chandrashekar |
| Designation |
Chief Dermatologist and Managing Director |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Department of Dermatology
Room No 1
5/1 4th Main MRCR Layout
Vijayanagar Bangalore
KARNATAKA
560040
India |
| Phone |
9740091155 |
| Fax |
|
| Email |
cutisclinic@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 |
Regaliz Medicare Ltd |
| Address |
37C/ 1st Floor, Charkop Industrial Estate
Charkop, Kandivali (West), Mumbai,
Maharashtra 400067 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Nayana NG |
CUTIS Academy of Cutaneous Sciences |
Department of Dermatology
Room No1
5/1,4th Main, MRCR layout, Vijayanagar, Bangalore
560040
Bangalore
KARNATAKA |
9901067756
nayanang1@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 |
NA |
NA |
| Intervention |
ST- Rich Duo (Tretinoin 0.1% with topical minoxidil 5%) |
Apply to the scalp twice daily at morning & night for 12 weeks.
In Night:
Apply 1 ML of ST Rich Booster (Tretinoin 0.1% gel) and after 30 minutes apply 1 ML of ST Rich M Solution (Minoxidil 5% Topical solution)
In Morning:
Apply only ST Rich M Solution on dry scalp. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Male & Female, between 18-45 years of age diagnosed with AGA and MPHL.
2.Norwood-Hamilton grades II to V.
3.Ludwig grades I and II.
3.Clinically diagnosed as Minoxidil non responder / partial responder based on global photography assessment.
5.Minoxidil non responder / partial responder based on Minoxidil Response Test.
6.Able to give informed consent. |
|
| ExclusionCriteria |
| Details |
1.Subjects on isotretinoin, radiation to the scalp, or chemotherapy within past 1 year
2.Use of any other AGA treatment during past 6 months
3.Subjects on botanicals/nutraceuticals for hair regrowth for the past 3 months
4.Men with uncontrolled hypertension or history of hypotension
5.Any chronic active scalp condition other than AGA
6.History of scalp reduction or use of hair weaves
7.Pregnant or lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage change in the proportion of anagen hair using frontal, temporal, and vertex trichoscopy in the treatment |
Baseline to 12 weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage change in the proportion of anagen hair using frontal, temporal, and vertex trichoscopy in the treatment
Assessment of global scalp photograph by investigator and subjects using 5 point scale (scale of 0â€4 (0: No improvement; 1: 1â€25% improvement; 2: 26â€50% improvement; 3: 51â€75% improvement; 4: 76â€100% improvement). |
Baseline to 12 weeks of treatment |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
23/07/2024 |
| Date of Study Completion (India) |
25/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
Background Summary Androgenetic alopecia (AGA) is a common hair loss disorder influenced by hormones, genetics, and environmental factors, with a prevalence of 58% among Indian males aged 30-50. The condition involves the gradual transformation of terminal hairs to vellus hairs and is less prevalent in African Americans, Chinese, and Japanese populations compared to Caucasians. Minoxidil, an FDA-approved treatment, promotes hair regrowth but is only effective in 30-40% of users due to variations in the sulfotransferase enzyme (SULT1A1) activity, which converts minoxidil to its active form. Topical retinoids, such as all-trans-retinoic acid, have been shown to enhance minoxidil efficacy by promoting its sulfonation. Regaliz has developed "ST-Rich Duo," a combination of tretinoin gel 0.1% w/v and minoxidil 5%, to improve hair regrowth and density by enhancing minoxidil absorption. Study purpose: This study purpose is to evaluate the efficacy and safety of tretinoin gel 0.1% w/v and minoxidil 5% combination in patients with limited or no response to minoxidil treatment. |