CLINICAL EVALUATION OF REVIVOGEN TOPICAL FORMULA FOR TREATMENT OF MEN AND WOMEN WITH ANDROGENETIC ALOPECIA.  A PILOT STUDY
 Alex Khadavi, MD, et al,. Los Angeles, CA USA 2004
Abstract: This study was done to determine whether Revivogen Scalp Therapy leads to clinical improvement in men and women with male and female pattern hair loss, respectively, in the vertex, anterior mid-scalp area, frontal and bi-temporal hairline. In a 12-month trial, 50 men and women (18 to 52 years of age) with male or female pattern hair loss, respectively, received topical Revivogen Scalp Therapy 1 cc/ daily, while 34 men and women received placebo hair solution. Efficacy was evaluated by patient and investigator assessments, and review of photographs.  Revivogen scalp therapy improved scalp hair by all evaluation techniques at twelve months. Patients’ self-assessment demonstrated that Revivogen scalp therapy slowed hair loss, increased hair thickness, and improved the appearance of hair. These improvements were corroborated by investigator assessments and assessments of photographs. There was no significant improvement in reduction of hair loss or hair growth in placebo group.  In men and women with male or female pattern hair loss, Revivogen Scalp Therapy 1 cc daily slowed the progression of hair loss and increased hair thickness of the vertex, anterior mid-scalp area, frontal and bi-temporal hairline in a clinical trial over 12 months.     
Background:Androgenetic alopecia (male/female pattern hair loss) occurs in persons with an inherited sensitivity to the effects of androgens on scalp hair (1,2). It is marked by visible loss of hair in areas of the scalp caused by progressive miniaturization of hair follicles (3-5). The condition does not occur in men with a genetic deficiency of the enzyme steroid 5–alpha-reductase (5-AR) type II, which converts testosterone to dihydrotestosterone (DHT), implicating DHT in its pathogenesis. Of two 5-AR isoenzymes in humans, (5-7) type I predominates in skin, including scalp, (10,11) whereas type II is present in hair follicles, (12) as well as the prostate. (11)<i> </i>Androgenetic alopecia (male pattern hair loss) is caused by androgen-dependent miniaturization of scalp hair follicles, with scalp dihydrotestosterone (DHT) implicated as a contributing cause. Revivogen, an inhibitor of both types I and II 5–alpha-reductase, decreases scalp DHT by inhibiting conversion of testosterone to DHT. <i> </i>
Objective:<i> </i>Our purpose was to determine whether Revivogen scalp therapy leads to clinical improvement in men and women with male and female pattern hair loss, respectively.
Methods:<i> </i>In a 1-year trial, 50 men and female (18 to 52 years of age) with male and female pattern hair loss received topical Revivogen Scalp Therapy 1cc/daily, and 34 men and women received placebo 1cc/daily. Efficacy was evaluated by patient and investigator assessments, and review of photographs by an expert panel.
Results<i>: </i>Revivogen Scalp Therapy improved scalp hair by all evaluation techniques at 1 year <i>(P </i>< .02 vs placebo, all comparisons).  Patients’ self-assessment demonstrated that Revivogen scalp therapy slowed hair loss, increased hair growth, and improved appearance of hair. These improvements were corroborated by investigator assessments and assessments of photographs. Adverse effects were minimal.
Conclusion:<i> </i>In men and women with male and female pattern hair loss, Revivogen Scalp Therapy 1 cc/daily slowed the progression of hair loss and increased hair growth in clinical trials over 12 months.  
METHODS
Study population:Men and women 18 to 52 years of age, with mild to moderately severe pattern hair loss according to a modified Norwood/Hamilton classification scale (II, III, IV or V) and Savin (II, III, IV or V) were enrolled. The principal exclusion included significant abnormalities on screening physical examination or laboratory evaluation, surgical correction of scalp hair loss, and the use of topical Minoxidil or Propecia, other medications whether oral or topical, medicinal or herbal within the last 12 months. Men and women were instructed not to alter their hairstyle or dye their hair during the studies. After a screening procedure, patients were randomly assigned to treatment with either Revivogen Scalp Therapy 1 cc/daily or placebo for 12 months. Patients visited the clinic every 3 months, where they completed a hair growth questionnaire and investigators completed assessments of scalp hair growth. Every 3 months, photographs of scalp were taken for assessment of hair growth by an expert panel. Reports of adverse events were collected throughout the study. 
Safety measurements: Safety measurements included clinical evaluations, adverse event reports, and patient body hair assessment via a self-administered questionnaire.   
Global Photographic Assessment:Standardized color global photographs (Kodak SR-100 speed 35-mm film) of the vertex scalp were taken with the head in a stereotactic positioning device.  Paired baseline and posttreatment slides were independently reviewed, with the use of the standardized 7-point rating scale (see above), by a panel of three dermatologists blinded as to treatment and experienced in photographic assessments of hair growth. This technique has previously been demonstrated to have excellent test-retest reproducibility and interpreter agreement.
EVALUATION PROCEDURES
Three predefined efficacy end points will provide a comprehensive assessment of changes in scalp hair from baseline.  
Patient self-assessment Patients assessed their scalp hair using a validated, self-administered hair growth questionnaire, consisting of 4 questions in the patient’s language on treatment efficacy and 3 questions on satisfaction with appearance.  (Figure 1)
Figure 1:
Patient self-assessment:
Patients assessed their scalp hair using a validated,
self-administered hair growth questionnaire, consisting
of 4 questions on treatment efficacy and 3 questions on
satisfaction with appearance.
  1. Since the start of the study, I could see that the balding area is getting smaller.
___Strongly agree
___Agree
___No opinion either way
___Disagree
___Strongly Disagree
 
  1. Because of the treatment I have received since the start of the study, the appearance of my hairs is:
     ___A lot better
     ___Somewhat Better
     ___A little better
     ___Same
     ___A little worse
     ___Somewhat worse
     ___A lot worse
 
  1. Since the start of the study, how would you describe the growth of your hair?
 ___Greatly increased
 ___Moderately increased
 ___Slightly increased
 ___No change
 ___Slightly decreased
 ___Moderately decreased
 ___Greatly decreased
 
  1. Since the start of the study, how effective do you think the treatment has been in slowing down your hair loss?
 ___Very effective
 ___Somewhat effective
 ___Not very effective
 ___Not effective at all

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