A Clinical Study to Evaluate the Safety and Efficacy of Nimson Almond oil in patients with Dandruff and Hairfall control.

Not Applicable

Completed

• Conditions: Dandruff and Hair fall Control

• Registration Number: CTRI/2023/06/054425
• Lead Sponsor: Aryanveda Cosmeceuticals

Brief Summary

This study is a prospective, single arm, open label, single centre clinical study to evaluate the safety and efficacy of Nimson Almond oil in Dandruff and Hairfall control.

. Primary Objective

• Reduction in the hair fall from Visit 1 to the end of the study.

• Reduction in the dandruff flakes and itching of the scalp.



Secondary Objective

• Improvement in the subjective hair assessment questionnaire.

• Improvement in the IP feedback questionnaire from visit 2 to end of the study

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-07
• Study Completion: 2023-08-15
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Subjects aged between 18 to 65 years.
• Subjects who willing to give written informed consent and ready to comply with the protocol.
• Subjects with active alopecia, seborrheic dermatitis of the scalp – “Total ASFS Score ≥ 16 4.
• Subjects with a minimum hair length of 2 inches and willing to maintain the same minimum length, hair style until the end of the study.

Exclusion Criteria

• Subjects on topical treatment for alopecia and seborrheic dermatitis for 8 weeks prior to enrollment.
• Subject with other dermatological disorders of the scalp that might interfere with the study evaluation.
• Subjects with significant scalp scarring.
• Subjects who have anemia or iron deficiency.
• Subjects who have previously undergone hair transplantation procedures.
• History of systemic or cutaneous malignancy or evidence of immunocompromised state.
• Subjects with history of skin allergy.
• Subjects on systemic steroids for more than 14 days within 2 months prior to enrollment.
• Female subjects who are reported pregnant/planning a pregnancy or lactating.
• Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrollment.
• Subjects, who in the opinion of the Investigator or the Expert Dermatologist are not eligible for enrollment in the study.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Excellent reduction in the shedding range of the hair in the “60 Second Hair Comb testâ€	Day 42
from Visit 1 to the end of the study.	Day 42
• Excellent reduction in the flaking severity in the “Adherent Scalp Flaking Score†from Visit 1 to the end of the study.	Day 42
• Excellent reduction of dandruff & itching of scalp.	Day 42

Secondary Outcome Measures

Name	Time	Method
• Reasonable improvement in the “Subjective Hair Assessment Questionnaire†score from visit 1 to end of the study.	• Reasonable improvement in the “Subject IP Feedback Questionnaire†score from Visit 2 to end of study.

Trial Locations

Locations (1)

Dr. Uday’s Advance Skin and Hair clinic; 🇮🇳 Bangalore, KARNATAKA, India

Dr. Uday’s Advance Skin and Hair clinic

🇮🇳Bangalore, KARNATAKA, India

Dr Uday Kumar

Principal investigator

6364147989

info@samahitha.com