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