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Completed NCT07063615

Safety and Efficacy of a Topical Cream in Mild-to-Moderate Seborrheic Dermatitis

Conditions: Seborrheic Dermatitis

Sex: All
Ages: 20 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 34
Sponsor: NovoBliss Research Pvt Ltd

Location: NovoBliss Research Private Limited Ahmedabad Gujarat

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07063615). StuddyBuddy aggregates publicly available trial information.