Brief Methodology:

It is Randomized, Placebo Controlled, Double blind, Multi-centric clinical study to evaluate in use tolerance and efficacy of a topical formulation Livon Hair Gain Tonic (containing Diaminopyrimidine Oxide) in men with androgenetic alopecia. (6 months study). The trial will be conducted in two centers in India. Product or placebo has to be applied approximately 4-6 ml on the entire scalp twice daily for 6 months. The primary objectives will be to evaluate Hair re-growth/Hair loss/alopecia progression by Global Photography, Hair re-Growth/Hair loss/alopecia using Photo-trichogram, Hair loss and alopecia progression by A/T Ratio, Hair growth by Anagen Hair, Hair density, Hair loss by telogen hair count and hair loss/ hair fall/ falling hair by telogen hair % on DAY-1,DAY-3,DAY-43,DAY-45,DAY-88,DAY-90,DAY-178,DAY-180. The secondary objectives of the study will be to evaluate efficacy of a test product Vs Placebo as per the Dermatologist on CGI-I Scale at the end of the study, efficacy of a test product Vs Placebo as per the subjects at the end of the study, tolerance of a test product on scalp by evaluating occurrence of any ADR like redness, itching, swelling etc. and tolerability of a test product by evaluation of occurrence of AE/SAE at all visits from baseline to the end of study. 

Results:

In the present study a total of 147 subjects were screened. There were 63 screen failures as they did not meet the inclusion / exclusion criteria. Of these subjects, 84 subjects were included in study and they received the study product or placebo.  A total of 14 subjects dropped out from the study due to loss to follow up and 70 subjects were considered as completers or efficacy evaluable cases. All the subjects who took even a single dose of the study drug were considered for safety evaluation. There were 34 subjects the in the Placebo group while 36 subjects in the LHGT group who were considered as evaluable cases.

A)   Age wise Distribution of subjects

The average age of subjects in the Group A (Placebo) was 32.47 ± 8.43 while in the Group B (LHGT) it was 33.33 ±8.12. There was no significant difference in the average age of subjects in the two study groups.

B)   Assessment of Hair re-Growth/Hair loss/alopecia progression by change in hair density using Photo-trichogram

There was a significant reduction in Hair density from baseline to follow up visit at day 43 to day 178 in Group A (Placebo) while in Group B (LHGT) there was significant increase in hair density levels. On analysing between the two groups significant difference was observed where Group B (LHGT) showed a significant increase in Hair density.

In the Group A (Placebo) the mean Hair density was 149.85 ±42.62 at baseline which was reduced significantly to 132.03 ±37.68, 124.63 ±42.40 and 105.06 ±40.28 at the end of day 43, day 88 and day 178 respectively. In the Group B (LHGT) the mean Hair density level at baseline visit was 148.49 ±53.11 which increased significantly to 169.62 ±47.54, 184.12 ±49.24 and 196.67 ±49.05 at the end of day 43, day 88 and day 178 respectively. At the end of study there was a decrease of 29.89% in Hair density in Placebo group while in LHGT group there was an increase of 32.45% over 180 days of application.

C)   Assessment of Total Hair count on Photo-trichogram

It is observed that there is a statistically significant improvement in Hair count in the Group B (LHGT) as compared to Group A. In Group A (Placebo) the mean Hair count was 108.36 ±30.39 at baseline which was reduced significantly to 95.25 ±27.18, 89.91 ±30.59 and 75.69 ±29.18 at the end of day 43, day 88 and day 178 respectively. In the Group B (LHGT) the mean Hair density level at baseline visit was 107.12 ±38.32, which increased significantly to 122.35 ±34.32, 132.84 ±35.54 and 141.88 ±35.37 at the end of day 43, day 88 and day 178 respectively. The hair count showed a decrease of 30.14% in Placebo group while in LHGT group there was an increase of 32.45% over 180 days of application

D)  Assessment of Hair loss/ alopecia progression by A/T Ratio

It was observed that in the Group A (Placebo) mean baseline value of A/T ratio was 2.65 ±0.52 which showed a significant reduction over follow up visit and was observed as 2.35±0.38, 2.24 ±0.51 and 1.90 ±0.40 at day 45, day 90 and day 180 respectively. In the Group B (LHGT) the mean A/T ratio was found to be 2.63 ±0.55 at baseline visit which increased significantly to 2.86 ±0.72, 3.01 ±0.88 and 3.20 ±0.96 at day 45, day 90 and day 180 respectively. Between groups analysis found that there was significant difference in the two groups where Group B (LHGT) showed significant increase in the AT ratio as compared to Group A (Placebo). In terms of percentage difference from baseline to 180 days there was a decrease of 28.31% in the A/T ratio in Placebo group while in the LHGT group there was a increase of 21.47% over 180 days of application.

E)   Assessment of Hair growth by Anagen % on Photo-trichogram

In the Group A (Placebo) the mean Anagen Hair Percentage was 72.67 ±3.94 at baseline visit which reduced to 70.13 ±3.82, 69.53 ±5.46 and 65.61 ±4.67 at the end of 45, 90 and 180 days respectively.  These changes were found to be significant when compared to baseline. In the Group B (LHGT) mean Anagen Hair Percentage at the baseline was 72.42 ±4.04 which increased to 73.99 ±4.90, 75.28 ±4.98 and 76.56 ±4.53 at the end of 45, 90 and 180 days respectively. These changes were found to be significant as compared to the baseline. On analysing between the two groups significant difference was observed for Anagen Hair Percentage where there was a significant increase in Anagen hair in Group B (LHGT) as compared to Group B (LHGT). The Anagen Hair percentage decreased by 9.72% in Placebo group while in the LHGT group there was an increase of 5.72% from baseline to 180 days

F)   Assessment of Telogen hair % by Photo-trichogram

It was observed that in the Group A (Placebo)mean baseline value of Telogen percentage was 27.09 ±3.97 which showed a significant increase over follow up visit and was observed as 29.64 ±3.83, 31.15 ±4.51 and 34.42 ±4.71 at day 45, day 90 and day 180 respectively. In the Group B (LHGT) the mean Telogen percentage was found to be 27.56 ±4.03 at baseline visit which non significantly reduced to 25.97 ±4.89, 24.71 ±4.98 and 23.43 ±4.53 at day 45, day 90 and day 180 respectively. Between groups analysis found that there was significant difference in the two groups. The difference from baseline to day 180 for Telogen hair percentage in the placebo group was an increase of 27.07% but the same in LHGT group was a decrease of 14.98%.

G)  Assessment of Hair growth rate by Photo-trichogram:

In Group A (Placebo) the mean Hair growth rate was 0.86 ±0.11 at baseline visit which at the end of 45, 90 and 180 days were found to be 0.85 ±0.10, 0.83 ±0.14 and 0.75 ±0.13 respectively. These decreases were found to be statistically non-significant at day 45 day 90 while on day 180 it was found to be significant. In the Group B (LHGT) the mean Hair growth rate at baseline was 0.88 ±0.09 which showed increase after 45 days to 0.90± 0.13, after 90 and 180 days it was found to be 0.91 ±0.13 and 0.92 ±0.16 respectively. This change in hair growth rate on day 45 and day 90 was found to be statistically non-significant but on day 180 was it was found to be significant. Between groups analysis showed non-significant difference on day 45 and day 90, while on day 180 it was found to be significant. There was a 12.98% decrease in hair growth rate as compared to baseline in Placebo group while in the LHGT group there was an increase of 5.33% over 180 days of application.

H)  Assessment of Hair re-growth/Hair loss/alopecia progression by Global Photography

Assessment of hair growth over Global photography at Frontal, Vertex and Overall (Total) revealed that there was no significant difference between the two groups when compared at day 45. There was a significant difference between the group for Vertex and overall (Total) score on day 90 and day 180. The mean score of Global photography for frontal area in placebo group was 0.85 ±0.66, 0.71 ±0.63, and 0.91 ±0.75 on day 45, day 90 and day 180 respectively. While in the LHGT group it was 0.86 ±0.80, 0.92 ±0.84, and 1.11 ±0.95 on day 45, day 90 and day 180 respectively, these were found to be significant. At the vertex on day 45, day 90 and day 180 this scores were 0.68 ±0.73, 0.62 ±0.65, 0.56 ±0.66 respectively in placebo group which in the LHGT group were found to be 0.61 ±0.77, 0.83 ±0.97, 1.08 ±0.73 respectively, these were found to be significant. Similarly the overall (Total) scores in placebo group were 1.53 ±1.38, 1.32 ±1.28, and 1.47 ±1.41 on day 45, day 90 and day 180 respectively. While in the LHGT group it were 1.47 ±1.56, 1.75 ±1.81, 2.19, ±1.68, these values were found to be significant.

Assessment of hair density over Global photography at Frontal, Vertex and Overall (Total) revealed that there was no significant difference between the two groups when compared at day 45 and day 90. The mean scores of Global photography for frontal area on day 45, day 90 and day 180 in placebo group were 0.85 ±1.05, 0.82 ±0.97, 0.97 ±0.63 respectively which in the LHGT group were 1.03 ±1.06, 1.17 ±0.70, 1.06 ±0.89. At the vertex on day 45, day 90 and day 180 these scores were 0.71 ±0.97, 0.82 ±0.76, 0.44 ±0.66 in placebo group which in the LHGT group were found to be 0.92 ±0.97, 0.94 ±0.86, 1.08 ±0.73. Similarly the overall (Total) scores on day 45, day 90 and day 180 in placebo group were 1.56 ±2.02, 1.65 ±1.73, 1.41 ±1.29 respectively while in the LHGT group these were 1.94 ±2.02, 2.11±1.56, 2.14 ±1.62

I)    Assessment of efficacy of test product by Physicians on CGI scale.

In Placebo group, 9 subjects showed minimal improvement in hair growth while 10 subject’s shows no change. 15 subjects show minimal to much worse hair growth on day 180 as compared to baseline visit.

In LHGT group, 14 subjects showed much improvement in hair growth while 16 subjects showed minimal improvement. 3 subjects showed no change in hair growth where at the same time 2 subjects’s showed minimal worsening on day 180 as compared to baseline visit

J)    Assessment of tolerability of a test product by evaluation of occurrence of AE/SAE

None of the AE was related to the study drug or procedure. No treatment or interruption of the study drug or procedure was required to resolve these episodes.

K)   Effect of study drug on Vitals:

There was no significant change in these parameters from baseline to every follow up visit till the end of study i.e. 180 days.

Conclusion:

The present study concludes that regular application of LHGT significantly improves hair growth and density as observed from Phototrichogram evaluation. A gradual and constant increase in hair density and growth was observed over a period of 180 days starting from as early as 45 days. Non application (Placebo) showed significant decrease on both hair growth and density.

There was a significant reduction in hair loss/alopecia progression as observed on A/T ratio with the use of LHGT over 180 days starting from day 45. The hair loss/alopecia also showed constant and continuous increase (worsening) in non-users (placebo). 

Significant increase in Anagen% and reduction in Telogen % was also observed in LHGT group, which was reverse in the placebo group, thus signifying the potential hair benefit of LHGT. Hair growth rate also showed a significantly better change as compared to non-users (placebo).

The above changes were observed on instrumental analysis as early as 45 days while the clinical and global photographic changes were seen at 3 months to 6 months follow ups. 

Physician’s (dermatologists) global evaluation also showed that a majority of subjects showing significant improvement with the use of LHGT.

LHGT was well tolerated and did not show any adverse effect on its regular application for 6 months duration.

LHGT can be recommended as a safe and effective remedy in the treatment of men suffering from Androgenic Alopecia.