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

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.

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.

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.

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.