A Clinical Study to Assess the Safety and Effectiveness of Scalp Cream for Symptom Relief and Microbiome Balance in Mild-moderate Seborrheic Dermatitis Patients.
Launched by NOVOBLISS RESEARCH PVT LTD · Jul 3, 2025
Trial Information
Current as of July 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical study is testing a special scalp cream to see if it is safe and helpful for people with mild to moderate seborrheic dermatitis, a common skin condition that causes redness, itching, and flaky skin on the scalp. The study will also look at how the cream affects the balance of good and bad microbes (tiny living things) on the scalp, which may play a role in the condition.
Adults between 20 and 55 years old with a confirmed diagnosis of mild to moderate seborrheic dermatitis may be eligible to join. Both men and women who are not pregnant or breastfeeding can participate, as long as they meet certain health and treatment guidelines. Participants will need to avoid using any other medicated shampoos or hair products during the study and must be willing to follow all study instructions, including attending scheduled visits and applying the cream as directed. The study is not yet recruiting, but if you join, you can expect careful monitoring by doctors to see how well the cream works and to ensure it is safe for your scalp.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • 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.
About Novobliss Research Pvt Ltd
Novobliss Research Pvt Ltd is a forward-thinking clinical trial sponsor dedicated to advancing medical research and improving patient outcomes. With a strong emphasis on innovation and integrity, the company specializes in conducting Phase I to Phase IV clinical trials across a diverse range of therapeutic areas. Novobliss Research is committed to fostering collaboration among healthcare professionals, regulatory bodies, and industry partners to ensure the highest standards of clinical excellence. Their experienced team leverages cutting-edge technology and robust methodologies to deliver reliable data, driving the development of safe and effective treatments for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Nayan Patel
Principal Investigator
NovoBliss Research Private Limited
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported