CTRI/2022/12/048288CompletedPhase 2
A prospective, open label, one arm study to evaluate the safety and efficacy of LAFZ ETHNIC Tea Tree Oil & Lemon Refreshing Anti-Dandruff Herbal Shampoo in reduction of mild to moderate dandruff in healthy male or female volunteers
Believe Pte. Ltd.,0 sites20 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Healthy Indian male/female volunteer aged between 18-45 years (both inclusive)
- •Willing to give Informed Consent
- •Subjects diagnosed with of mild to moderate dandruff, assessed by mean total Adherent Scalp Flaking Score (ASFS) of 8 zones in the scalp.
- •Willing to complete the study assessments/questionnaires.
- •Willing to avoid usage of his/her own hair care products in controlling hair fall and dandruff for at least one week before the commencement and during this study.
Exclusion Criteria
- •Pregnancy or breast feeding.
- •Patients diagnosed with severe dandruff, Itching, flaking, pruritis and visible inflammation over face, retro auricular area, and the upper chest.
- •Patients with inflammatory or infective scalp conditions.
- •Patients with history of hypersensitivity to hair products
- •Patients with mild to severe anaphylaxis reaction.
- •Patients with pre existing severe systemic disease necessitating long term medication.
- •Evidence of significant uncontrolled co morbid disease which in the investigators opinion would jeopardize patient participation.
- •History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ.
- •Participation in the current or previous clinical trial with any approved or investigational products during the past 1 month.
Investigators
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