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. Enrolment will be based on scalp skin type, which may be classified as dry, oily, or combination. Participants will be randomized in a 22:12 ratio to receive either Treatment A or Treatment B, respectively. The study aims to complete evaluations for 30 participants-20 in the Treatment A group and 10 in the Treatment B group. The potential patient will be screened as per the inclusion and exclusion criteria only after obtaining the written informed consent from the patients. Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called on the telephone by the recruiting department prior the enrolment visit. Patients will be told during screening (prior to enrolment) not to use any hair product including hair oil and hair cream on the study visit day. There will be total of 4 visits during the study. The duration of the study will be 60 (+2 days) from the enrolment. Subjects will be instructed to visit the facility as per below visits. 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): A scripted telephonic follow-up schedule, will be implemented for Treatment group A to assess whether any seborrheic dermatitis (SD) symptoms have recurred following discontinuation of the treatment, 30 days after study completion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
34
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 Ensure the scalp is completely dry (within 5 minutes of towel-drying post-shower) before applying the cream. At night, ensure the cream is fully absorbed before lying down to avoid transfer to bedding materials like pillows or sheets.
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 Ensure the scalp is completely dry (within 5 minutes of towel-drying post-shower) before applying the cream. At night, ensure the cream is fully absorbed before lying down to avoid transfer to bedding materials like pillows or sheets.
NovoBliss Research Private Limited
Ahmedabad, Gujarat, India
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.
ASFS scale Mild: 16-24, Moderate :25-34, Severe : 35-80
Time frame: 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 s
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.
change in flake coverage using CASLiteNova from 8 parts of the scal
Time frame: from baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups.
To evaluate the effectiveness of the test treatment by assessing reduction in itching from baseline, both within treatment group and between treatment groups.
reduction in itching using VAS scale for itching
Time frame: 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
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.
change in erythema Index using Mexameter® MX 18
Time frame: 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.
To evaluate the effectiveness of the test treatment by assessing change in scalp microbiome from baseline, both within treatment group and between treatment groups.
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longitudinal changes in scalp microbiome composition and host response by collecting BD swabs and FLOQ swabs
Time frame: Samples will be collected at three time points: baseline on Day 01 (pre-treatment) and post usage of test treatment on Day 30 (+2 Days) and Day 60 (+2 Days) and between treatment groups.
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.
change in scalp barrier function (Transepidermal Water loss) using Tewameter® TM Hex
Time frame: 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.
To evaluate the effectiveness of the test treatment by assessing change in sebum production from baseline, both within treatment group and between treatment groups.
change in sebum production using Sebumeter® SM 815
Time frame: 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.
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.
reduction in hair fall and non-adherent flake count using 60 second hair combing test
Time frame: baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups.
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.
change in general appearance of scalp skin i.e. Itchiness, redness, roughness, and scaliness
Time frame: baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days)
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.
assessing change in hair density and hair thickness using CASLiteNova
Time frame: on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups.
To evaluate the effectiveness of the test treatment by assessing treatment perception questionnaire through Quality of Life Questionnaire and PGIC questionnaire f
change in treatments perception questionnaire through Quality of Life Questionnaire using 5-point Likert scale and PGIC questionnaire
Time frame: 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.