| CTRI Number |
CTRI/2025/07/090946 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety, Efficacy Study] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Assess the Safety and Efficacy of Scalp Cream in patients with Dandruff |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of scalp cream for Symptom Relief and Microbiome Balance in mild-moderate Seborrheic Dermatitis patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB250017-BM_1.0_30June |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alka Makwana |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,Ahmedabad
Ahmedabad, Gujarat, India
313, Silver Radiance-4, Gota,
Ahmadabad
GUJARAT
382421
India |
| Phone |
09909013287 |
| Fax |
|
| Email |
dermatology@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Sub Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,Ahmedabad
Ahmadabad
GUJARAT
382421
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshwari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,Ahmedabad
NovoBliss Research Pvt. Ltd.
Ahmadabad
GUJARAT
Maheshvari Patel
India |
| Phone |
09909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Blossom Microbiotics LLC
4111-E Rose Lake Dr #6005,
Charlotte,
North Carolina
|
|
|
Primary Sponsor
|
| Name |
Blossom Microbiotics LLC |
| Address |
4111-E Rose Lake Dr #6005,
Charlotte,
North Carolina
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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# 313, Silver Radiance-4, Gota,Ahmedabad
Ahmedabad, Gujarat, India - 382481.
Gandhinagar
GUJARAT
382421
India
Ahmadabad
GUJARAT |
09909013286
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: L219||Seborrheic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Microbiome-Powered Cream |
Mode of Usage: Apply a generous amount of the cream to the affected area of the scalp. Gently part the hair using a wide-tooth comb or your fingertips to ensure direct contact with the scalp. Extend slightly beyond affected areas.
Massage the cream gently into the skin until fully absorbed. Do not rinse off after application.
Frequency: Apply twice daily once after the morning shower and once before bedtime.
Route of Administration Topical
Note
For best results, the cream should be applied within 5 minutes of towel drying, while the scalp is slightly damp and soft. At night, ensure the cream is fully absorbed before lying down to avoid transfer to bedding materials like pillows or sheets.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Age: 20-55 years (both inclusive) at the time of consent.
2) Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
3) Females of childbearing potential must have a self-reported negative urine pregnancy.
4) Subject is in good general health as determined by the Investigator on the basis of medical history.
5) Patients must have a confirmed diagnosis of mild to moderate scalp seborrheic dermatitis, with an ASFS score of at least 16 at the time of screening. The severity grade will be evaluated by the dermatologist using the ASFS scale during the clinical study.
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/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) Patients are willing to give written informed consent and are willing to follow the study procedure.
9) Patients who commit not to use any other medicated/ prescription shampoos/hair care products, any other hair growth products or hair colour or dye, other than the test treatment for the entire duration of the study.
10) Patients who are having refrigerator at their home for storage of test treatment.
11) Subject is willing and able to comply with study procedures, including all scheduled visits, treatment applications, and assessments.
12) Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
13) Subject must be able to understand and provide written informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1) Subject with known allergy or sensitization to test treatment ingredients.
2) Subjects with a history of dermatological scalp conditions other than seborrheic dermatitis or dandruff (e.g., psoriasis, tinea capitis, lichen planopilaris) .
3) Subject who had taken topical treatment of dandruff for at least 4 weeks.
4) Subject who had taken any systemic treatment for at least 3 months.
5) Subject who have plans of shaving scalp hair during the study.
6) Use of systemic or topical medications (e.g., corticosteroids, immunosuppressants, retinoids) known to affect skin or scalp within the past 3 months, or any medical history likely to interfere with study.
7) Subject has any concurrent skin disease.
8) History of alcohol or drug addiction.
9) Subjects with an allergy to dairy products.
10) Subjects with a history or current presentation of visibly inflamed, infected, or severely irritated scalp, or known sensitivity to topical or cosmetic products.
11) Pregnant or breast feeding or planning to become pregnant during the study period.
12) Use of antibiotics, antifungal medications, or oral/topical probiotics within the past 4 weeks
13) History of chronic illness which may influence the cutaneous state.
14) Subject have participated any clinical research study related to hair care products within past 3 months.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effectiveness of the test treatments by assessing the change in Adherent Scalp Flaking Score (ASFS) from baseline, both within treatment group and between treatment groups.
2. To evaluate the effectiveness of the test treatment by assessing the change in flake coverage for quantification of adherent flakes from baseline, both within treatment group and between treatment groups.
3. To evaluate the effectiveness of the test treatment by assessing reduction in itching from baseline, both within treatment group and between treatment groups.
4. To evaluate the effectiveness of the test treatment by assessing change in Scalp Erythema Index from baseline, both within treatment group and between treatment groups
|
1. To evaluate the effectiveness of the test treatments by assessing the change in Adherent Scalp Flaking Score (ASFS) from baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups using ASFS scale.
2. To evaluate the effectiveness of the test treatment by assessing the change in flake coverage using CASLiteNova from 8 parts of the scalp from baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups.
3. To evaluate the effectiveness of the test treatment by assessing reduction in itching from baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups using VAS scale for itching.
4. To evaluate the effectiveness of test treatment by assessing change in erythema Index using Mexameter® MX 18 and by Dermatologist and Dermatologist trained evaluator from baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of the test treatment by assessing change in scalp microbiome from baseline, both within treatment group and between treatment groups. |
Evaluations will be done at three time points on Day 01, Day 30, Day 60 |
| To evaluate the effectiveness of the test treatment by assessing change in scalp barrier function from baseline, both within treatment group and between treatment groups. |
Evaluation will be done at four time points at baseline on Day 01 and at T30 mins of Day 01, Day 30 and Day 60 |
| To evaluate the effectiveness of the test treatment by assessing change in sebum production from baseline, both within treatment group and between treatment groups. |
Evaluation will be done at four time points at baseline on Day 01 and at T30 mins of Day 01, Day 30 and Day 60 |
| To evaluate the effectiveness of the test treatment by assessing reduction in hair fall and non-adherent flake count from baseline, both within treatment group and between treatment groups. |
Evaluations will be done at three time points on Day 01, Day 30, Day 60 |
| To evaluate the effectiveness of the test treatment by assessing change in general appearance of scalp from baseline, both within treatment group and between treatment groups. |
Evaluation will be done at four time points at baseline on Day 01 and at T30 mins of Day 01, Day 30 and Day 60 |
| To evaluate the effectiveness of test treatment by assessing change in hair density and hair thickness from baseline, both within treatment group and between treatment groups. |
Evaluations will be done at three time points on Day 01, Day 30, Day 60 |
| To evaluate the effectiveness of the test treatment by assessing treatment perception questionnaire through Quality-of-Life Questionnaire by using 5-point Likert scale and PGIC questionnaire from baseline, both within treatment group and between treatment groups. |
Evaluation will be done at four time points at baseline on Day 01 and at T30 mins of Day 01, Day 30 and Day 60 |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2025 |
| 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="2"
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
|
A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the safety and efficacy of scalp cream for Symptom Relief and Microbiome Balance in mild-moderate Seborrheic Dermatitis patients. A total of 34 participants, including males and non-pregnant, non-lactating females aged between 20 and 55 years (inclusive) with a confirmed diagnosis of mild to moderate seborrheic dermatitis, will be enrolled in the study. - Visit 01(Within 15 Days): Screening, ICD obtained. - Visit 02 (Day 1): Enrolment, Baseline Evaluations, Treatment Usage, Post Treatment Usage Evaluations at 30 mins (T30 Mins). - Visit 03 (Day 30 +2 Days): Post-usage evaluation - Visit 04 (Day 60 +2 Days): Post-usage evaluation and End of Study. - Telephonic Follow Up (Day 90 + 2 Days)
|