CLINICAL EVALUATION OF REVIVOGEN TOPICAL FORMULA FOR TREATMENT OF MEN AND WOMEN WITH ANDROGENETIC ALOPECIA. A PILOT STUDY
5. Compared to the beginningthe 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 (P < .05), the first efficacy time point, and at all subsequent time points (P < .005). For individual questions, Revivogen Scalp Therapy was superior to placebo for 7 of 7 questions (all P values < .003).
Investigator assessment Revivogen Scalp Therapy was superior to placebo at all time points (P < .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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