Seborrheic Dermatitis
Conditions
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.
Detailed description
Thirty-four participants were randomized: 22 to the treatment group and 12 to the placebo group. Thirty-two participants completed the study: 20 treatment and 12 placebo. Two participants in the treatment group were lost to follow-up. Treatment was applied to affected scalp areas and, where applicable, other seborrheic dermatitis-affected sebum-rich sites, including the hairline/forehead, postauricular area, and neck/nape. Safety and tolerability were assessed throughout the 60-day treatment period by monitoring adverse events.
Interventions
OTHERMicrobiome-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.
OTHERPlacebo Hair 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.
Sponsors
Blossom Microbiotics LLC
NovoBliss Research Pvt Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double Blind Study
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Age: 20-55 years (both inclusive) at the time of consent. * Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females). * Females of childbearing potential must have a self-reported negative urine pregnancy. * Subject is in good general health as determined by the Investigator on the basis of medical history. * 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. * 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. * 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. * Patients are willing to give written informed consent and are willing to follow the study procedure. * 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. * Patients who are having refrigerator at their home for storage of test treatment. * Subject is willing and able to comply with study procedures, including all scheduled visits, treatment applications, and assessments. * Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits. * Subject must be able to understand and provide written informed consent to participate in the study.
Exclusion criteria
* Subject with known allergy or sensitization to test treatment ingredients. * Subjects with a history of dermatological scalp conditions other than seborrheic dermatitis or dandruff (e.g., psoriasis, tinea capitis, lichen planopilaris). * Subject who had taken topical treatment of dandruff for within preceding 4 weeks. * Subject who had taken any systemic treatment for within preceding 3 months. * Subject who have plans of shaving scalp hair during the study. * 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. * Subject has any concurrent skin disease. * History of alcohol or drug addiction. * Subjects with an allergy to dairy products. * Subjects with a history or current presentation of visibly inflamed, infected, or severely irritated scalp, or known sensitivity to topical or cosmetic products. * Pregnant or breast feeding or planning to become pregnant during the study period. * Use of antibiotics, antifungal medications, or oral/topical probiotics within the past 4 weeks * History of chronic illness which may influence the cutaneous state. * Subject have participated any clinical research study related to hair care products within past 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days) | ASFS scale Mild: 16-24, Moderate :25-34, Severe : 35-80, eight scalp zones were each graded from 0-10 and summed to produce a total score from 0-80. ASFS showed XX% improvement |
| 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. | from baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days). | change in flake coverage using CASLiteNova from 8 parts of the scalp. Gives scalp condition images |
| To evaluate the effectiveness of the test treatment by assessing reduction in itching from baseline, both within treatment group and between treatment groups. | 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). | reduction in itching using VAS scale for itching |
| 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. | 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). | change in erythema Index using Mexameter® MX 18 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days). | change in scalp barrier function (Transepidermal Water loss) in g/m²/h using Tewameter® TM Hex |
| To evaluate the effectiveness of the test treatment by assessing change in sebum production from baseline, both within treatment group and between treatment groups. | baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days). | change in sebum production in μg/cm² using Sebumeter® SM 815 |
| 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. | baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days). | reduction in hair fall and non-adherent flake count using 60 second hair combing test |
| 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. | baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days) | change in general appearance of scalp skin i.e. Itchiness, redness, roughness, and scaliness |
| 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. | on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days). | assessing change in hair density (sqcm) and hair thickness (µm) using CASLiteNova |
| To evaluate the effectiveness of the test treatment by assessing treatment perception questionnaire through Quality of Life Questionnaire 5-point likert scale and PGIC questionnaire | Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days). | change in treatments perception questionnaire through Quality of Life Questionnaire using 5-point Likert scale and PGIC questionnaire |
Countries
India
Contacts
PRINCIPAL_INVESTIGATORDr Alka Makwana
NovoBliss Research Private Limited
Outcome results
None listed