NCT07063615

A Clinical Study to Assess the Safety and Effectiveness of Scalp Cream for Symptom Relief and Microbiome Balance in Mild-moderate Seborrheic Dermatitis Patients.

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.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Seborrheic Dermatitis

Interventions

Type	Name	Description
OTHER	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 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.
OTHER	Placebo 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 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.

Timeline

• Start date: 2025-07-21
• Primary completion: 2026-02-09
• Completion: 2026-02-09
• First posted: 2025-07-14
• Last updated: 2026-02-05

Locations

1 site across 1 country: India