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

Sponsored by NovoBliss Research Pvt Ltd

About this trial

Last updated a month ago

Study ID

NB250017-BM_1.0_30June

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

20 to 55 Years
All Sexes

Not accepting

Healthy Volunteers

Trial Timing

Ended 7 months ago

What is this trial about?

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.

What are the participation requirements?

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.