| CTRI Number |
CTRI/2024/01/061549 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
17/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety, Efficacy Study] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to assess the safety and effectiveness of anti-acne face wash in healthy adult female subjects having mild to moderate facial acne. |
|
Scientific Title of Study
|
A prospective, single-arm, single-centre, safety, and efficacy study of anti-acne face wash in healthy adult female subjects having mild to moderate facial acne. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB230041-IL_Version_D(02)_29Dec23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator - Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator - Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| ITC Limited,
ITC LSTC, 3, 1st Main Rd, 1st Stage,
Phase-1, Peenva, Bengluru,
Karnataka 560058 |
|
|
Primary Sponsor
|
| Name |
ITC Limited |
| Address |
ITC LSTC, 3, 1st Main Rd, 1st Stage,
Phase-1, Peenva, Bengluru,
Karnataka 560058 |
| Type of Sponsor |
Other [Healthcare and FMCG] |
|
|
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 Nayan Patel |
NovoBliss Research Private Limited |
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj
Gandhinagar
GUJARAT |
9909013286
dr.nayan@novobliss.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS – Independent Ethics Committee |
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 |
Anti-Acne Face Wash |
Marketed and Manufactured By: ITC Limited
Mode of Usage: Splash some water on face and neck. Take required amount of face wash on palm and lather it as per normal usage of facewash. Massage in circular motion and rinse it with plain water.
Frequency: Twice a Day
Duration: 28 days
Route of Administration: Topical
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) Age: 18 to 45 years (both inclusive) at the time of consent.
2) Sex: Healthy non-pregnant and non-lactating females.
3) Females of childbearing potential must have a self-reported negative pregnancy test.
4) Subjects are generally in good health.
5) Subject with acne of mild to moderate severity as per the IGA scale.
6) Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
7) If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device or injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
8) Subjects are willing to give written informed consent and are willing to come for regular follow up.
9) Subjects who commit not to use medicated skincare products other than the test product for the entire duration of the study.
10) Subject who have not participated in a similar investigation in the past three months.
11) Willing to use test product throughout the study period. |
|
| ExclusionCriteria |
| Details |
1) History of any dermatological condition of the skin disease.
2) Subject with present condition of allergic response to any cosmetic product.
3) Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, antihistamines, corticotherapy etc.) that might influence the outcome of the study.
4) Subject having acne of severe incidence (presence of nodules, cysts or numerous pustules) which requires pharmaceutical treatment.
5) Subjects who have applied topical treatment for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study.
6) History of alcohol or drug addiction.
7) Subjects using other marketed anti-acne products during the study period.
8) History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
9) Any other condition which could warrant exclusion from the study, as per the dermatologist’s or investigator’s discretion.
10) Pregnant or breastfeeding or planning to become pregnant during the study period.
11) History of chronic illness which may influence the cutaneous state.
12) Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the effectiveness of the test treatment in terms of change in skin hydration by using Corneometer CM 825.
2. To evaluate the effectiveness of the test treatment in terms of change in transepidermal water loss by Tewameter TM Hex.
3. To assess the effectiveness of the test treatment in terms of change in skin softness (pliability) by using cutometer Dual MPA 580
4. To assess the effectiveness of test treatment in terms of change in acne lesion by using Visiopore PP 34 N.
5. To assess the effectiveness of the test treatment in terms of change in skin sebum level by using Sebumeter SM 825.
6. To assess the effectiveness of the test treatment in terms of change in skin pH by using Skin pH Meter.
7. To evaluate the effectiveness of the test treatment in terms of change in L, a, and ITA by using Skin Colorimeter. |
Before usage of the test treatment on day 01 (for baseline), and after usage of the test treatment at T30 mins on Day 01, Day 03, Day 07, Day 14 and Day 28. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To assess the effectiveness of the test treatment in terms of change in skin texture, pore size and skin exfoliation (dead skin cell remove) by using Visioscan VC 20 Plus. |
Before usage of the test treatment on day 01 (for baseline), and after usage of the test treatment at T30 mins on Day 01, Day 03, Day 07, Day 14 and Day 28. |
2. To assess the effectiveness of the test treatment in terms of change in acne severity by using IGA scoring scale by Dermatologist or dermatologist trained evaluators.
|
Before usage of the test treatment on day 01 (for baseline), and after usage of the test treatment at T30 mins on Day 01, Day 03, Day 07, Day 14 and Day 28. |
3. To assess the effectiveness of the test treatment in terms of change in skin pores by using Image Pro analysis software.
|
Before usage of the test treatment on day 01 (for baseline), and after usage of the test treatment at T30 mins on Day 01, Day 03, Day 07, Day 14 and Day 28. |
| 4. To evaluate the effectiveness of the test treatment in terms of change in erythema, edema, peeling, oiliness, scaling, inflammation, eruption, blackheads, whiteheads and pores by using 4-point scale by dermatologist or dermatologist trained evaluator. |
Before usage of the test treatment on day 01 (for baseline), and after usage of the test treatment at T30 mins on Day 01, Day 03, Day 07, Day 14 and Day 28. |
| 5. To assess the effect of the test treatment in terms of treatment perception by using 9-point hedonic scale. |
Before usage of the test treatment on day 01 (for baseline), and after usage of the test treatment at T30 mins on Day 01, Day 03, Day 07, Day 14 and Day 28. |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/01/2024 |
| Date of Study Completion (India) |
20/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
A prospective, single-arm,
single-centre, safety, and efficacy study of
anti-acne face wash in healthy adult female subjects having complaints of facial acne.
A total of up to 37 healthy adult non-pregnant/non-lactating females with an age of 18 – 45 years, with equal distribution of mild and moderate acnes will be enrolled to
ensure a total of 35 evaluable subjects complete the study. Subjects will be instructed to visit the
facility as per the below visits.
-
Visit 01
(Day 01): Screening, Enrolment, Baseline
Evaluation, on site product usage period, Post usage evaluation
-
Visit 02 (Day 03): Treatment Phase, Evaluations
-
Visit 03 (Day 07): Treatment Phase, Evaluations
-
Visit 04 (Day 14): Treatment Phase, Evaluations
- Visit 05 (Day 28 +2 Days): Evaluations,
End of Study |