Clinical study of Hair Oil formulation in Hair loss in females.
- Conditions
- Mild to moderate Hair loss in females
- Registration Number
- CTRI/2018/05/014122
- Lead Sponsor
- Emami Ltd
- Brief Summary
**Brief Methodology:**
It is an open label, single arm, prospective clinical studyto evaluate efficacy and safety of Hair Oil formulation in mild to moderateHair loss in females. The study will be conducted at one site in India. Subjects will beadvised to apply 5 to 10 ml hair oil daily on the scalp with fingertips before going to bed atnight or before bath for 60 days. The Primary objectives of study will beassessment of hair fall by running finger test and assessment of hair breakageby comb test over a period of 60 days. The Secondary objectives of study willbe assessments of hair fall by Hair Pull test, assessment of hair growth bycomparing against standard nonusers, assessment of effect of hair oil ondandruff in females by standard dandruff evaluation strip, assessment of effectof hair oil on quality of hair based on subject questionnaire, global assessmentfor overall change in hair loss by the physician and subject, and assessment ofsafety by observing episodes, severity and duration of any allergic reactionsand adverse events.
**Results:**
**A). Primary Objectives:**
**1)****Assessment of hair fall reduction by running finger test over a periodof 2 months:**
**T**hereis a significant reduction in hair fall as analyzed by Running Finger test frombaseline to 15 days, which continued till the end of the study. The averagehair fall at the baseline visit was 79.35 ±28.54, which significantly reducedto 53.60 ±32.05 at the end of 15 days. At the end of 30 days the hair fall furtherreduced to 41.42 ±27.19 while at the end of 45 days it was observed to be 37.36±25.94. At the end of 60 days the average hair fall was seen to be 34.36 ±32.72,which was significant as compared to its baseline reading. It was also observedthat there was a 47.8% reduction in hair fall at the end of one month while atthe end of 60 days the average hair fall reduced by 56.69%.
**2)****Assessment of hair breakage by comb test over a period of 2months:**
The average no of hair as per comb test were 16.04 ±13.16 atthe baseline visit. This reduced to 11.04 ±9.55 and 9.36 ±10.18 at the end of15 days and 30 days respectively, which was found to be statisticallysignificant. At the end of 45 days and 60 days the counts were 8.13 ±9.71 and 8.55±8.94 respectively. These reductions were found to be significant as comparedto the baseline. There was a 41.64% reduction in hair count by comb test at theend of 30 days, which further improved to 46.7% at the end of 60 days.
**B). Secondary Outcome:**
**1). Assessment ofhair fall by Hair Pull test over aperiod of 2 months**
The average no of hair fall as per pull test were 1.64 ±1.68 at the baseline visit. This reduced to 1.04 ±1.20 and 0.76 ±1.09at the end of 15 days and 30 days respectively, which was found to bestatistically significant. At the end of 45 days and 60 days the counts were 0.82±1.33 and 0.78 ±1.49 respectively. These reductions were found to besignificant as compared to the baseline. There was a 53.85% reduction in hair fallby pull test at the end of 30 days which further improved to 52.75% at the endof 60 days.
**2). Assessment of effect of EM/HO-01 hair oils on dandruff infemales by standard dandruff evaluation strip.**
**T**heDandruff score was 1.75 ±1.27 at the baseline visit. Thisreduced to 1.38 ±1.16 and 1.47 ±1.39 at the end of day 15 and day 30 respectively which wasfound to be statistically significant. This continued further at 45 days and 60days where the score were 1.31 ±1.44 and 0.95 ±1.10 respectively. Thesereductions were found to be statistically significant. The percentage reductionin Dandruff score was found tobe 20.83 % at the end of 15 days, 15.62% at day 30, 25 % at day 45 and 45.83 %at day 60 as compared to the baseline.
**3). Assessment of effect on quality of hair based on subjectquestionnaire.**
**a)****a). Assessment ofeffect on Visibility of scalp, Smoothness of Hair, Thickness of Hair.**
The visibility of scalp as evaluated on VAS. It is observedthat at day 30, subjects had an average score of 0.94 ±1.06 (improvement), whilethe end of 60 days the score was 1.70 ±1.10. This change was found to bestatistically significant between these two visits.
Smoothness was evaluated on VAS scale by the subject on Day30 and day 60. It is observed that the average smoothness was found to be 2.14±0.64, while it was 2.78 ±1.06 at the end of 60 days. The difference betweenday 30 and day 60 was found to be statistically significant.
**T**hicknessof hair was evaluated on VAS scale by the subject on Day 30 and day 60. It wasobserved that the average thickness was found to be 1.62 ±0.85 in EM/HO-01group. Thickness showed a further increase of average to 2.30 ±1.13 at the endof day 60.
**b). Assessment of effect on hair growth**
It is observed that 6% of subjects showed mild worsening oftheir condition of hair fall at Day 30. On day 60 this percentage was observedas 8%. It was also observed that 24% had no change at day 30 and 6% wererecorded to have no change on day 60. 72% and 86% of subjects reported ofSlight to moderate improvement in their condition at Day 30 and Day 60respectively.
**c). Assessment of effect on appearance of hair:**
It is observed that 6% of subjects showed mild worsening oftheir condition of hair fall at Day 30. On day 60 this percentage was observedas 8%. Of these 24% had no change at day 30 and 6% were recorded to have nochange on day 60. It was observed that 72% and 86% of subjects reported ofSlight to Moderate improvement in their condition at Day 30 and Day 60respectively.
**d)****Assessment of effect inslowing down hair loss:**
It is observed that 6% of subjects showed either severe ormoderate or mild worsening of their condition of hair fall at Day 30. On day 60this percentage was observed as 8%. In the study it was observed that 30% hadno change at day 30 and 20% were recorded to have no change on day 60. 64% and 72%of subjects reported of Slight to Marked improvement in their condition at Day30 and Day 60 respectively.
**e)****Assessment of effect on greying of hair:**
It is observed that all the subjects showed no change intheir greying of hair at day 30 while at day 60, 98% of the subjects showed nochange while 2% subjects showed slight improvement.
**4)** **Globalassessment of Overall Change in hair loss by the Physician:**
Physicians Global improvement scale (CGI-I) showed that 82%of the subjects were very much improved, much improved or minimally improved. 10%of subjects did not have any change while 8% subjects were minimally to muchworse.
**5)** **Global assessmentof Overall Change in hair loss by Subject:**
Subject’s Global improvement scale (CGI-I) showed that 82%of the subjects were very much improved, much improved or minimally improved.10% of subjects did not have any change while 8% subjects were minimally tomuch worse.
**6)** **Assessment ofOverall Safety as per the Physician:**
It is observed that 90% of the subjects had excellentoverall safety while 10% had good overall safety. Assessment of adverse eventsshowed apart from a few subjects complaining of itching in the scalp none ofthe adverse events were related to the study product. Assessment of vitals likepulse, temperature and respiratory rate also observed that there were nosignificant changes on these parameters over the period of 60 days of study inboth the groups.
**7)** **Assessment of safety by observing episodes, severity andduration of any allergic reactions & adverse events:**
There were total few adverse events (AEs) such as cough,facial palsy, nausea, insomnia, burning throat, loose motion, vomiting andhyperacidity during the trial. Among this no AEs were related to the study Product.
**Conclusion:**
Itcan be concluded from the study that there was a significant reduction in hairfall as assessed by running finger test. Assessment by comb test for hairbreakage observed that there was a significant reduction at the end of 60 daysof study. Assessment onother parameters also showed significant improvement in the quality of hair,dandruff etc.
Assessment of safety showed that all the subjectsshowed excellent to good safety with only a few subjects having mild episodesof itching of the scalp.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 50
- 1.Female subjects between the age group of 18- 45 years both inclusive.
- 2.Subjects suffering from mild to moderate hair loss (40-140 Hair by Comb test and Finger Test).
- 3.Subjects who are infrequent hair oil users.
- 4.Subjects who are willing to give informed consent and ready to comply with the protocol.
- 5.Subjects who are ready to provide regular follow ups till the completion of the study.
- 1.Subjects with severe Hair fall due to any clinically significant disorder/s like anemia, thyroid disorders etc.
- 2.Subject with severe dermatological disorders of the scalp that might interfere with the study evaluation.
- 3.Subjects with recent disease history like malaria, typhoid, jaundice and scalp diseases and subjects who in the opinion of the investigator are not eligible for enrollment in the clinical study.
- 4.Subjects who have regularly used anti-hair fall treatment with hair oil over the last 6 months.
- 5.Subjects who have previously undergone hair transplantation procedures.
- 6.Subjects on systemic steroids for more than 14 days within 2 months prior to enrollment.
- 7.Subjects on immunosuppressive drugs.
- 8.Known cases of Hypersensitivity to hair oil contents.
- 9.Subjects who have participated in any other clinical study since last 3 months.
- 10.Subjects who are reported pregnant/planning a pregnancy or lactating.
- 11.Menopausal Women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Assessment of hair fall by running finger test over a period of 60 days. Day -3, Day 0, Day 15, Day 30, Day 45, Day 60 2.Assessment of hair breakage by comb test over a period of 60 days Day -3, Day 0, Day 15, Day 30, Day 45, Day 60
- Secondary Outcome Measures
Name Time Method 1.Assessments of hair fall by Hair Pull test. 2.Assessment of hair growth by comparing against standard nonusers.
Trial Locations
- Locations (1)
D. Y. Patil University School of Ayurveda Nerul Navi Mumbai
🇮🇳(Suburban), MAHARASHTRA, India
D. Y. Patil University School of Ayurveda Nerul Navi Mumbai🇮🇳(Suburban), MAHARASHTRA, IndiaDr Maheshkumar HaritPrincipal investigator9322217607drmaheshkharit@rediffmail.com