| CTRI Number |
CTRI/2024/12/077823 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects and safety of two creams, calcitriol and adapalene, in patients with mild and moderate acne. |
|
Scientific Title of Study
|
Comparative Efficacy of Topical Calcitriol versus Topical Adapalene in the Treatment of Mild and Moderate Acne: A Randomized 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 |
Aditi Shende |
| Designation |
Assistant Professor |
| Affiliation |
Symbiosis Medical College for Women and SUHRC |
| Address |
Dept of dermatology Symbiosis Medical College for Women and SUHRC Lavale
Lavale, Pune
Pune
MAHARASHTRA
412115
India |
| Phone |
|
| Fax |
|
| Email |
draditishende@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neeta Gokhale |
| Designation |
Head of Department |
| Affiliation |
Symbiosis Medical College for Women and SUHRC |
| Address |
Dept of dermatology Symbiosis Medical College for Women and SUHRC Lavale
Pune
MAHARASHTRA
412115
India |
| Phone |
9823154022 |
| Fax |
|
| Email |
hod.dermatology@smcw.siu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Shende |
| Designation |
Assistant Professor |
| Affiliation |
Symbiosis Medical College for Women and SUHRC |
| Address |
Dept of dermatology Symbiosis Medical College for Women and SUHRC Lavale
Pune
MAHARASHTRA
412115
India |
| Phone |
7020966077 |
| Fax |
|
| Email |
draditishende@gmail.com |
|
|
Source of Monetary or Material Support
|
| Symbiosis Medical College for Women &
Symbiosis University Hospital and Research Centre,
Symbiosis International (Deemed University), Mulshi road, Lavale, Pune, Maharashtra India 412115 |
|
|
Primary Sponsor
|
| Name |
Dr Aditi Shende |
| Address |
Department of Dermatology Symbiosis Medical College for Women & Symbiosis University Hospital and Research Centre, Mulshi road, Lavale, Pune India Maharashtra 412115 |
| Type of Sponsor |
Other [] |
|
|
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 Aditi Shende |
Symbiosis Medical College for Women |
Department of Dermatology, Room no 2820 OPD 16 Basement floor, Lavale
Pune
MAHARASHTRA |
7020966077
draditishende@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee of Symbiosis International University |
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 |
0.0003% Calcitriol ointment |
Once daily application for 3 months |
| Comparator Agent |
0.1% Adapalene gel |
Once daily application for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 years or older, of either gender and any racial/ethnic group with mild (GAGS score 1-18) and moderate acne (GAGS score 19-30) according to Global Acne Grading System (GAGS)
2. Subjects must understand and sign the informed consent before participation
|
|
| ExclusionCriteria |
| Details |
1. Severe acne (GAGS score more than 30)
2. Pregnancy or breastfeeding
3. History of hypersensitivity or allergic reaction to study medications
4. On topical treatment (4 weeks before participation) or systemic treatment (3 months before enrolment) for acne
5. Any concomitant dermatological or systemic illness
6. Patients who are unable to follow up
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduction in total lesion count (Total, Inflammatory and Non-inflammatory)
2. Reduction in acne severity
and global acne grading score |
0, 4 weeks, 8 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety profile of both the topicals graded on 4 point scale |
0, 4 weeks, 8 weeks and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Acne vulgaris is one of the most common dermatological conditions characterized by comedones, papules, pustules, nodules, and cysts in severe cases. Multiple options for managing mild and moderate acne include topical retinoids, benzoyl peroxide, minocycline, topical clindamycin, and oral antibiotics. However these are associated with multiple adverse effects like increasing antibiotic resistance and retinoid dermatitis. Hence, there is a need to evaluate newer therapeutic options for acne. With the increasing role of Vitamin D in the pathophysiology of acne, there is a need for a study comparing the efficacy of topical vitamin D analogs like calcitriol with adapalene in the treatment of mild and moderate acne. The objective of this study is to compare the efficacy and safety profile of topical calcitriol versus topical adapalene in the treatment of mild and moderate acne. A Randomized controlled trial
will be conducted to assess the efficacy and safety profile of two treatment options in patients with mild and moderate
acne vulgaris: topical 0.0003% calcitriol ointment and topical 0.1% adapalene
gel. This study will be conducted after
approval from the institutional ethics committee. The patients fulfilling the inclusion criteria will be
enrolled in the study. Written informed consent will be taken from each
patient. A detailed history including demographic details (age, sex), family
history, signs of polycystic ovary syndrome (PCOS), and history of acne
vulgaris (age of onset, duration, any prior treatment history) will be
recorded. Clinical examination will be done for acne type, site of involvement,
lesion count (inflammatory and non-inflammatory), and severity of acne using Global acne grading system score.
Patients will be randomly divided into two groups. Group 1 patients will
receive topical calcitriol and group 2 patients
will receive topical adapalene. Patients will
be asked to apply the creams daily at night for 12 weeks. Patients will be
asked to follow up at 4, 8 and 12 weeks. At each follow-up visit
patients will be assessed for the primary outcome (reduction in total
lesion count and acne severity using global acne grading system score) and the secondary
outcome (safety profile). A photographic
record will be maintained. At every follow-up visit,
patients will be assessed for adverse effects like
erythema, itching, scaling, and burning
sensation on a 4-point scale. |