CLINICAL EVALUATION OF REVIVOGEN TOPICAL FORMULA FOR TREATMENT OF MEN AND WOMEN WITH ANDROGENETIC ALOPECIA.  A PILOT STUDY

 5. Compared to the beginning the beginning of the study, which statement best describes your satisfaction with the appearance of:

                                         Very  Satisfied       Satisfied     Neutral       Dissatisfied     Very Dissatisfied 

a)   the hairline at the front of  your hair?                                                 

b)  the hair on top of your head?                                                               

c)  your hair overall?                                                                                 


 

Investigator assessment Investigators assessed patients at all time points, using a standardized 7-point rating scale of hair growth compared with baseline (–3 = greatly decreased, –2 = moderately decreased, –1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased). 

Laboratory Evaluation Hematology, urinalysis, chemistry, and hormone measurements were performed at baseline and every 6 months. Serum chemistry, including prostate-specific antigen (PSA), and serum hormones, including testosterone and DHT were assayed.   

RESULTS

Table I.  Percentage of men and women with improvements in scalp hair while on Revivogen Scalp Therapy compared to Placebo after 12 months of treatment

 

Patient self-assessment                             Revivogen            Placebo               Difference

 (questionnaire)                                        Group (50)           Group (34)    (Percent Difference)

 

 

Q1: Size of bald spot                            82                 21                 61

Q2: Appearance of hair                     86                 29                 57

Q3: Growth of hair                               88                12                76

Q4: Slowing hair loss                          88                 18                70

Q5a: Satisfaction with frontal hairline        78                18                60

Q5b: Satisfaction with hair on top               88                21                     67

Q5c: Satisfaction with hair overall              86                18                68

  

Investigator assessment

Increased hair growth                        84                24                60

Global photographic assessment

Increased hair growth                        86                 12               74


Patient self-assessment Revivogen Scalp Therapy was superior to placebo as early as month 3 <i>(P </i>< .05), the first efficacy time point, and at all subsequent time points <i>(P </i>< .005). For individual questions, Revivogen Scalp Therapy was superior to placebo for 7 of 7 questions  (all <i>P </i>values < .003). 

Investigator assessment Revivogen Scalp Therapy was superior to placebo at all time points <i>(P </i>< .02). By month 12, 88 % of Revivogen Scalp Therapy-treated patients were rated as improved by the investigators versus 8 % of placebo-treated patients. Assessment of hair growth by investigators also demonstrated the benefit of Revivogen Scalp Therapy treatment. The blinded comparison of paired pretreatment and post treatment global photographs by the expert panel, which also assessed change from baseline but was not subject to recall bias, demonstrated minimal, if any, placebo effect. By this assessment, Revivogen Scalp Therapy treatment produced progressive improvement in hair growth for 12 months, whereas placebo-treated patients without significant improvement. Revivogen Scalp Therapy appeared to improve the quality (i.e., thickness, pigment, length and/or growth rate) of hair.

Laboratory Assessment There was no significant change in laboratory levels in either the chemistry or hormonal evaluation in either the Revivogen or placebo group. 

 

ADVERSE EVENTS

In the study, a slightly higher proportion of Revivogen Scalp Therapy-treated than placebo-treated patients reported adverse events related to scalp irritation (2%). Only 1 man (2%) in the Revivogen group.  No adverse events were reported in the placebo group.  As expected from this body of experience, no individual in the current study experienced impairment of sexual function. No other significant adverse effects of Revivogen Scalp Therapy were observed.

DISCUSSION

In this study, Revivogen Scalp Therapy treatment produced significant improvements in scalp hair in men and women with male and female pattern hair loss, respectively. The efficacy of Revivogen Scalp Therapy was evident within 3 months of therapy. Hair density, first measured at 3 months by photographs, progressively increased over 1 year in the Revivogen Scalp Therapy group. In contrast, the placebo group progressively lost hair, consistent with the miniaturization process and the natural history of male and female pattern hair loss.  Significantly more patients in the Revivogen Scalp Therapy group reported improvements in scalp hair growth and appearance, as well as satisfaction with appearance, compared with the placebo group. Satisfaction with the frontal hairline and bitemporal growth was also improved compared with placebo. Revivogen Scalp Therapy 1 cc/ daily improved scalp hair in men and women with male and female pattern hair loss within 3 months, with the benefit increasing with continued treatment. In contrast, men and women receiving placebo had no improvement. These results confirm that Revivogen Scalp Therapy is an effective treatment for male and female pattern hair loss.  Since Revivogen works to decrease levels of DHT, and DHT is a key factor in those men and women genetically predisposed for development of male and female androgenetic Alopecia, Revivogen is an effective anti-DHT treatment for the treatment of androgenetic alopecia. Adverse events caused by Revivogen Scalp Therapy treatment were minimal. Revivogen Scalp Therapy 1 cc/ daily represents a new topical therapy for male and female pattern hair loss.

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