Clinical study to evaluate effectiveness, safety and tolerability of Dhathri Hair Care Cream in comparison with Regular Hair Cream in the management of hairfall and dandruff of the scalp.
- Conditions
- Health Condition 1: L659- Nonscarring hair loss, unspecifiedHealth Condition 2: L219- Seborrheic dermatitis, unspecified
- Registration Number
- CTRI/2013/05/003644
- Lead Sponsor
- Dhathri Ayurveda Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
1. Subjects between the age group of 21 to 45 years.
2. Subjects who are able to give written informed consent and ready to comply with the protocol.
3. Subjects with active alopecia, and seborrheic dermatitis of the scalp â?? â??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.
1. Subjects on topical treatment for alopecia and seborrheic dermatitis for 4 weeks prior to enrollment.
2. Subject with other dermatological disorders of the scalp that might interfere with the study evaluation.
3. Subjects with significant scalp scarring.
4. Subjects who have anemia or iron deficiency.
5. Subjects who have previously undergone hair transplantation procedures.
6. History of systemic or cutaneous malignancy or evidence of immunocompromised state.
7. Subjects with history of skin allergy.
8. Subjects on systemic steroids for more than 14 days within 2 months prior to enrollment.
9. Female subjects who are reported pregnant/planning a pregnancy or lactating.
10. Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrollment.
11. Subjects, who in the opinion of the Investigator or the Expert Dermatologist are not eligible for enrollment in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Excellent reduction in the shedding range of the hair in the â??60 Second Hair Comb testâ?? from Visit 1 to end of the study. <br/ ><br>2. Excellent reduction in the flaking severity in â??Adherent Scalp Flaking Scoreâ?? from Visit 1 to end of the study. <br/ ><br>Timepoint: 60 second Hair Comb Test: 50% reduction in the shedding range from Visit 1-Visit 3 <br/ ><br>Adherent Scalp Flaking Score:Reduction of 10 score or to 0 score in the Total ASFS Score from Visit 1-Visit 3 <br/ ><br>Objective Hair Assessment Questionnaire:Decrease by 10 scores from Visit 1-Visit 3 <br/ ><br>Subjective Hair Assessment Questionnaire: Decrease by 5 scores from Visit 1-Visit 3 <br/ ><br>Subject IP Feedback Questionnaire: Total score of 12 in Visit 2&Visit 3 <br/ ><br>Worsening of alopecia and seborrheic dermatitis of the scalp
- Secondary Outcome Measures
Name Time Method 1. Reasonable improvement in the â??Objective Hair Assessment Questionnaireâ?? from Visit 1 to end of the study. <br/ ><br>2. Reasonable improvement in the â??Subjective Hair Assessment Questionnaireâ?? from Visit 1 to end of the study. <br/ ><br>3. Reasonable improvement the â??Subject IP Feedback Questionnaireâ?? from Visit 2 to end of study. <br/ ><br>Timepoint: 60 second Hair Comb Test: 25-49% reduction in the shedding range from Visit 1-Visit 3 <br/ ><br>Adherent Scalp Flaking Score:Reduction of 6 in the Total ASFS Score from Visit 1-Visit 3 <br/ ><br>Objective Hair Assessment Questionnaire:Decrease by 5 scores from Visit 1-Visit 3 <br/ ><br>Subjective Hair Assessment Questionnaire: Decrease by 3 scores from Visit 1-Visit 3 <br/ ><br>Subject IP Feedback Questionnaire: Total score of 6 in Visit 2&Visit 3 <br/ ><br>Development of adverse reactions due to the usage of the IP/Comparator