| CTRI Number |
CTRI/2024/09/074120 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Spironolcatone for acne treatment |
|
Scientific Title of Study
|
Topical 5 percent spironolactone versus placebo in the management of acne vulgaris - A randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shekhar Neema |
| Designation |
Professor |
| Affiliation |
Base Hospital |
| Address |
Room No 2
Department of Dermatology
Base Hospital
Lucknow
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9830032821 |
| Fax |
|
| Email |
shekharadvait@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shekhar Neema |
| Designation |
Professor |
| Affiliation |
base Hospital |
| Address |
Room No 2
Department of Dermatology
Base Hospital
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9830032821 |
| Fax |
|
| Email |
shekharadvait@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shekhar Neema |
| Designation |
Professor |
| Affiliation |
base Hospital |
| Address |
Room no 2
Department of Dermatology
Base Hospital
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9830032821 |
| Fax |
|
| Email |
shekharadvait@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 2, Department of Dermatology, Base Hospital, Lucknow, india 226002 |
|
|
Primary Sponsor
|
| Name |
Base Hospital Lucknow |
| Address |
Department of Dermatology
Base Hospital, Lucknow
India 226002 |
| Type of Sponsor |
Research institution |
|
|
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 Shekhar Neema |
Base Hospital, Lucknow, India |
Room no 2
Department of Dermatology
Base Hospital
Lucknow
Lucknow
UTTAR PRADESH |
9830032821
shekharadvait@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Command Hospital (CC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
5% spironolactone gel |
5% spironolcatone gel application twice a day for 6 weeks |
| Comparator Agent |
vehicle |
Vehicle/placebo to be applied twice a day for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Female patients suffering from mild to moderate acne (Grade 1 and 2)
Not on any topical or systemic treatment for last 1 month |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating female
severe acne
comorbid disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 50% improvemnt in acne severity |
at 2 weeks, 4 weeks and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Physcian global assessment |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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 2 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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="0"
Months="6"
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
|
Background: Acne is a common skin condition. The treatment options for managing acne include topical antibiotics, topical retinoids, systemic antibiotics and retinoids depending on the severity of the disease. Oral spironolactone is used in the management of hormonal acne. Oral spironolactone is associated with anti-androgen adverse effects such as menstrual irregularity and breast tenderness.
Purpose: This trial aims to study the efficacy of compounded topical spironolactone. The outcome will be measured at 6 weeks. |