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Spectral DNC - Clinical Studies on Minoxidil and Aminexil

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One-Year Observational Study

Dermatologists conducted a 1-year observational study in 984 men with male-pattern hair loss. 

The study evaluated the effectiveness of a 5% minoxidil topical solution in halting hair loss and stimulating new hair growth, as well as the patients' perceptions of efficacy and side effects. 

Over the 1-year period of the study, patients applied 1 milliliter (ml) of 5% minoxidil solution twice day to hair-loss areas of the scalp. 

Every 3 months during the study, patients collected hair lost in a hair washing and sent the collected hair to a laboratory for counting.

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At the end of 1 year:

  • The dermatologist investigators reported that hair loss areas of the scalp had become smaller in 62% of the patients, unchanged in 35.1% and larger in 2.9%.
  • In evaluating minoxidil effectiveness in stimulating hair regrowth, the investigators found the 5% solution very effective in 15.9% of patients, effective in 47.8%, moderately effective in 20.6% and ineffective in 15.7%.
  • Hairs lost during washing numbered a mean 69.7 at the beginning of the study, and a mean 33.8 at the end of the study-a measure of the effectiveness of 5% minoxidil in halting hair loss in the patients studied.
  • The mean score of patient satisfaction on a scale of 0 (extremely dissatisfied) to 10 (very satisfied) increased from 2.9 at study beginning to 4.4 at study end. Patient satisfaction scores were lower than the estimates of the physician investigators: the investigators rated efficacy of treatment as good or very good 25% more often than did the patients.
  • Side effects, mostly dermatologic, were reported by 3.9% of patients in the study. None of the side effects was classified as serious.

Four-Month Surveillance Study

A 4-month surveillance study involving 743 men with male-pattern hair loss was designed to evaluate (1) how quickly men using 1 ml of 5% minoxidil solution twice a day began to notice reduced hair loss and/or new hair growth, (2) efficacy of 5% minoxidil solution in improving hair density in areas affected by male-pattern hair loss, and (3) side effects associated with use of 5% minoxidil solution.

All results were evaluated and reported by the men involved in the study; 150 physicians with male-pattern hair loss were among the 743 patients studied.

At the end of 4 months:

  • The scalp area affected by male-pattern hair loss (the "balding" area) was judged smaller by 67.3% of the men, unchanged by 31.9% and larger by 0.8%.
  • The 5% minoxidil solution was judged very effective in stimulating new hair growth by 7.5% of the men, effective by 55%, moderately effective by 31.3% and ineffective by 6.2%.
  • Hair density (the "fullness" of scalp hair) was judged improved by 74.2% of the men, unchanged by 24.3% and worsened by 1.5%.
  • Of the 669 men who reported when results of minoxidil treatment were first noticeable, 13.9% reported results in the first month, 52.3% during the second month, and 33.8% during the third month.
  • Skin-related side effects were reported by 13 patients.

Results reported by the 150 physicians in the study did not differ substantially from results reported by the other men in the study.

Results of these two post-marketing studies generally confirm results of previous studies of the efficacy and safety of minoxidil. While many persons are benefited by 2% or 5% minoxidil in treatment of pattern hair loss, results vary from person to person for a variety of reasons including individual responses to the agent and relentlessness of hair loss progression. Results that are satisfactory to some patients are unsatisfactory to others, perhaps because results do not meet pre-treatment expectations.

Best treatment results are likely to be realized when the person with hair loss consults a physician hair restoration specialist. Rational expectations for treatment outcome are most reliably based on (1) diagnosis of the cause of hair loss, (2) assessment of the characteristics of hair loss in the individual patient, and (3) a treatment plan based upon diagnosis and assessment, and agreed upon by the patient and physician hair restoration specialist. A physician hair restoration specialist is able to monitor the effectiveness of medical therapy clinically and through use of comparison photos, as well as provide other medical and surgical options to augment the benefits of minoxidil. Minoxidil solution is even more effective when combined with the oral medication finasteride (Propecia®), and is also compatible with hair restoration surgery. For example, a patient may have follicular unit transplantation to create a natural looking hairline near the front of the scalp, and use minoxidil and finasteride to preserve the hair on top of the scalp.]

Normal results

Topical minoxidil is much more effective at treating baldness that occurs on the top, or crown, of the head than it is at causing hair growth on other parts of the head. Minoxidil does not work for everyone and there is no predictor, in early 2001, of whether or not it will be effective in any particular person. Clinical tests on the effectiveness of topical minoxidil in men with baldness on the top of the head showed that 48% of men who had used minoxidil for one year reported moderate to dense re-growth of hair within the treated area. Thirty-six percent reported minimal re-growth. While 16% reported no re-growth. Similar percentages have been reported in women.

In both men and women, hair re-growth generally does not begin until the medicine has been used for at least four months. The first signs that minoxidil may be effective in a particular person usually occur after approximately 90 days of treatment, when the patient notices that he or she is losing (shedding) much less hair than prior to beginning treatment.

When new growth begins, the first hairs may be soft and barely visible. For some patients, this is the extent to the effectiveness of this medication. For others, this down-like hair develops into hair of the same color and thickness as the other hairs on their heads.

Minoxidil is a treatment for hair loss, it is not a cure. Once a patient stops taking minoxidil, he or she will most likely lose all of the re-grown hair within 90 days of stopping the medication and no further hair growth will occur.


Title: Long-term efficacy of topical minoxidil in male pattern baldness. 
Author: Katz HI, Hien NT, Prawer SE, Goldman SJ 
Source: J Am Acad Dermatol, 16: 3 Pt 2, 1987 Mar, 711-

A 24-month clinical trial, begun on a double-blind basis, was conducted in 153 men with discernible male pattern baldness of the crown with the use of either topically applied placebo, 2% minoxidil, or 3% minoxidil solution. After 4 months the patients using placebo were switched to 3% minoxidil solution. At 12 months, there were statistically significant increases in terminal hair growth within a 1-inch target area in those treated with 2% or 3% minoxidil solution, in comparison with baseline counts. However, there were few patients who had appreciable cosmetic restoration. At 12- and 24-month intervals, progressive regression or stabilization of the size of the bald area was noted in the majority of patients. This therapeutic or preventive effect was statistically significant. The data on actual target area hair counts suggested that the 2% minoxidil solution was equal to or more efficacious than the 3% minoxidil solution. Baseline vital signs and laboratory parameters remained essentially unchanged. Topical minoxidil was well tolerated, with no serious drug-related adverse reactions noted during the study.

Language of Publication: English


Title: Topical minoxidil therapy for androgenic alopecia in the Middle East. The Middle-Eastern Topical Minoxidil Study Group.
Karam P Address: American University Hospital of Beirut, New York, NY 10022. 
Source: Int J Dermatol, 32: 10, 1993 Oct, 763-6

BACKGROUND. A 48-week open label trial was conducted in five Middle-Eastern countries (Lebanon, Egypt, Saudi Arabia, Jordan, and the United Arab Emirates) to determine the safety and efficacy of 2% minoxidil in the treatment of early androgenic alopecia and to compare the response with Western countries. METHODS. One hundred and ninety-five men aged between 19 and 47 years were enrolled. The duration of their baldness varied from 6 months to 10 years, and they all showed a type III vertex or type IV of the modified Hamilton scale. Baldness pattern, diameter of the balding area, hair counting within a 2.5 cm bald patch as well as investigator's and patient's evaluation were regularly noted. RESULTS. No significant changes were observed in vital signs or laboratory parameters. Of the 161 patients considered evaluable at 48 weeks, 80% showed moderate to dense growth. The mean increase in nonvellus hair at 12 months was 234. CONCLUSIONS. The age of the patient and the type of baldness rather than its duration affected the final outcome.

Language of Publication: English


Title: Australian trial of topical minoxidil and placebo in early male pattern baldness. 
Author: Connors TJ, Cooke DE, De Launey WE, Downie M, Knudsen RG, Shumack S, Eggleston AS Address: Monash Medical Centre Clayton, Vic. 
Source: Australas J Dermatol, 31: 1, 1990, 17-25

One hundred and sixty nine men with early male pattern baldness (androgenic alopecia) were treated in a random, double-blind fashion with either 2% minoxidil solution or placebo vehicle for 24 weeks, one ml applied twice daily. After 24 weeks all patients received the active solution until week 48. After 24 weeks the minoxidil treated patients had increased their non-vellus hair counts significantly more than the placebo treated group; means were 37.6 and 8.8 hairs per reference area, 95% C.I. for difference = 10.85 to 60.75. The rate of non-vellus hair regrowth was also greater among minoxidil treated patients than placebo treated patients. Nine (12.5%) evaluable minoxidil treated patients compared with 2 (2.7%) evaluable placebo treated patients reported moderate or dense hair regrowth at week 24. Minimal regrowth was reported by 18 (25%) active group and 15 (20%) placebo group patients. The investigators considered that 3 (2%) of the minoxidil group and None of the placebo group had moderate hair regrowth and that None had dense regrowth. After 48 weeks treatment 28 (23%) patients considered that they had moderate hair regrowth and the investigators considered that 14 (12%) patients had moderate regrowth. None had dense growth. No serious adverse reactions or deaths were reported. Minoxidil solution appeared to be an efficacious and safe treatment for early androgenic alopecia.

Language of Publication: English


Title: Treatment of androgenic alopecia with topical minoxidil 
Author: Brenner S, Tamir A 
Address: Dermatology Dept., Sourasky Medical Center, Tel Aviv. 
Source: Harefuah, 121: 9, 1991 Nov 1, 297-302

Minoxidil, a vasodilator, was first marketed in 1979 as an oral antihypertensive. Since hypertrichosis occurred as an adverse effect in most patients treated, a 2% topical solution was developed for use in men with androgenic alopecia. It was approved by the American Food and Drug Administration and by the Israel Ministry of Health. A follow-up of 30 cases treated with the preparation is presented. Efficacy of treatment was assessed by hair counts in a marked area on the balding scalp, as well as by subjective evaluations of patients and physicians. The treatment was beneficial in 63%: balding was slowed in most, while in a minority hair density actually increased. However, in only 6.6% was dramatic cosmetic improvement achieved.

Language of Publication: Hebrew


Title: A critical review of the results of clinical experimentation with topical minoxidil 2%
Original Title:
Revisione critica di alcuni risultati della sperimentazione clinica con minoxidil topico al 2%.

Author: D'Ovidio R, Di Prima T, De Pasquale R, D'Ovidio F 
Address: Istituto Semeiotica Chirurgica, Universitŕ di Bari. 
Source: G Ital Dermatol Venereol, 125: 4, 1990 Apr, V-IX

The results of clinical double-blind trials using minoxidil 2% demonstrate the real efficacy of the drug in producing satisfactory esthetical results in some 30% of treated patients. One aspect of the results of this research which is not yet clear is the significant increase in the number of hairs, also found in voluntary subjects treated with placebo. In the present study is hypothesised that this increase may be partially explained by the failure to take into account the physiological seasonal variations in hair density, and by the confusion caused by the use of the "non-vello" category which is used to describe terminal (thick) and indeterminate (thin) hairs. In our study placebo failed to produce a significant increase in the number of terminal hairs, thus explaining why, even in the presence of an increased number of "non-vello" hairs, on average there was no real cosmetic benefit in these subjects.

Language of Publication: Italian


Title: Enhanced in vitro hair growth at the air-liquid interface: 
minoxidil preserves the root sheath in cultured whisker follicles.
Author: Waldon DJ, Kawabe TT, Baker CA, Johnson GA, Buhl AE 
Address: Upjohn Laboratories, Department of Dermatology Research, Kalamazoo, Michigan 49001. Source: In Vitro Cell Dev Biol Anim, 29A: 7, 1993 Jul, 555-61

Inasmuch as hair follicles are difficult to maintain in culture, the study of hair biology using cultured hair follicles has met with only limited success. In our attempts to solve the problem of follicle degeneration, we cultured follicles at the air-surface interface on a modified collagen matrix (Gelfoam). In follicles cultured at the air-surface or submerged, we examined follicular morphology, hair shaft growth, sulfotransferase levels, cysteine incorporation, an expression of a tissue inhibitor of metalloproteinase (TIMP), and ultra-high sulfur keratin (UHSK). Follicles cultured at the air-liquid interface produced a 2.7-fold increase in hair growth and maintained an anagen-like morphology. Substrates such as nylon mesh seeded with fibroblasts, Full Thickness Skin, or 5-microns polycarbonate filter also supported hair growth, whereas Gelfilm, GF-A glass filter, filter paper, or 1-micron polycarbonate filter did not. The UHSK expression was significantly higher in the air-liquid interface cultures compared to the submerged culture. Several potassium channel openers, including minoxidil, a minoxidil analog, and the pinacidil analog (P-1075), all stimulated significant cysteine incorporation in follicles. Minoxidil and its analog specifically preserved the follicular root sheath, in contrast to P-1075 which did not, indicating a difference in the two drug types. The preservation of the root sheath was measured by increased TIMP expression and sulfotransferase activity and indicates that the root sheath is a target tissue for minoxidil. Our results show that follicles cultured at the air-liquid interface maintain a better morphology and produced greater hair growth than follicles cultured on tissue culture plastic.

Language of Publication: English


Minoxidil was the first drug approved by the FDA for the treatment of androgenetic alopecia (hair loss). Before that, minoxidil had been used as vasodilator drug prescribed as oral tablet to treat high blood pressure, with side effects that included hair growth and reversal of male baldness. In the 1980s, UpJohn Corporation came out with a topical solution of 2% minoxidil, called Rogaine, for the specific treatment of androgenetic alopecia. Since the 1990s, numerous generic forms of minoxidil have become available to treat hair loss while the oral form is still used to treat high blood pressure.

The popularity hair loss treatment is due to the general preference in the overall population for the cosmetic appearance of a full head of hair. Minoxidil is used to stimulate hair growth in areas of the scalp that have stopped growing hair. As of early 2001, the exact mechanism of action of minoxidil is not known.


People who have had a prior unusual or allergic reaction to either minoxidil or propylene glycol, a non-active chemical in the Rogaine solution, should not use topical minoxidil. People who have had a previous allergic reaction to preservatives or dyes may also be at risk for having an allergic reaction to minoxidil.

People who are using cortisone, or cortisone-like drugs (corticosteroids), petroleum jelly (Vaseline), or tretinoin (Retin-A) on their scalps should consult their doctors prior to using minoxidil. The use of any of these products in conjunction with minoxidil may cause excessive minoxidil absorption into the body and increase the risk of side effects.

Also, people who have skin problems or irritations of the scalp, including sunburn, may absorb too much minoxidil and increase their risk of side effects. As for oral minoxidil, the form prescribed for high blood pressure, patients should use minoxidil only under medical supervision to ensure that excessive amounts of the drug are not absorbed into their bodies. Large amounts of minoxidil may increase the severity of the symptoms and side effects of hypertension.

Minoxidil may pass from mother to child through breast milk. Therefore, women who are breastfeeding should not use minoxidil.


For the treatment of hair loss, minoxidil is available as a topical solution that is generally either 2% or 5% minoxidil in propylene glycol. The propylene glycol ensures that the applied minoxidil is evenly spread across the affected area and easily absorbed through the skin. As of early 2001, the 5% solution is only approved by the FDA for use on men. Approximately 1 milliliter of minoxidil solution is applied to the scalp once a day using the fingertips or a pump spray. It should be applied from the center of the area being treated outward.

In the treatment of high blood pressure, oral minoxidil is usually prescribed when other medications have failed to treat the condition. Dosage is usually 2.5-100 mg per day as a single dose for adults and 200 micrograms to 1 mg per kg of body weight for children.


The most common side effects of topical minoxidil use are itching and skin irritation of the treated area of the scalp. Unwanted hair growth may also occur adjacent to treated areas or in areas where the medicine has been inadvertently transferred several times. This unwanted hair growth adjacent to the treatment area may be particularly distressing to women when the face is involved. The itching and irritation usually subside after the drug has been used for approximately two weeks. If symptoms persist after this time, minoxidil use should be halted until a physician has been consulted.

Extremely rare side effects that may occur if too much topically or orally administered minoxidil is being absorbed in the body include:

  • Changes in vision, most commonly blurred vision; 
  • Chest pain; 
  • Very low blood pressure; 
  • Decreased sexual desire; 
  • Fast or irregular heartbeat; 
  • Flushing of the skin; 
  • Headache; 
  • Lightheadedness; 
  • Numbness or tingling in the hands, feet, or face; 
  • Partial, or complete, impotence; 
  • Rapid weight gain; 
  • Swelling of the hands, feet, lower legs, or face.

Aminexil Studies

The successful effects of Aminexil on hair loss have been proved by 6 medical investigations. In one world-wide study (1994 -1995) mentioned below you see the test results for yourself. This investigation was carried out in various hospitals. A treatment course consisted of the continued use of a bottle of Aminexil for 42 consecutive days.

  • A clinical trial with placebo;
  • 130 test participants;
  • Test participants aged between 18 and 55 years, with Alopecia type II to V;
  • Treated with a bottle of Aminexil daily for 42 consecutive days.

World-wide study of 130 test participants (Hospital Rothschild, Saint Louis and Amersham) have all shown that by using the Aminexil product hair starts to grow back.  It is evident during the test that there is clear distinction between those treated with Aminexil and placebo.

A placebo is a false product, used especially for medical tests. For the benefit of test purposes this product is not recognizable to the dermatologist and the test participant. In this way a result can be obtained from the false product and the real product (Aminexil). A balance is made up out of the test results from the placebo and the Aminexil product.

You have already seen above that persons treated with Aminexil experienced regenerated hair growth. The test participants treated with the placebo product lost their hair growth.

Aminexil of Kérastase produces hair growth

The hair growth thickness investigation carried out by the Laboratoire de Cosmétométrie showed that by using Aminexil hair thickness increased by 6%.This investigation also showed that persons/subjects treated with Aminexil experienced more hair thickness than those treated with the placebo product.

Aminexil of Kérastase, therefore, allows for hair preservation.

Aminexil controls seasonal hair loss (Hospital Rothschild, Saint-Louis and Amersham) .Many people suffer from hair loss after the summer or wintertime. Aminexil showed that such persons are no longer troubled by seasonal hair loss.

Aminexil from Kérastase allows for hair preservation throughout the whole year

These studies took place in the Hospital Rothdchild, Amersham, Saint-Louis, Labotatoire and Cosmétométrie. Dermatologist Boersma, who is attached to the hair and skin clinic in Dordrecht, took charge of the Dutch research.

Aminexil holds the patent for its product world-wide under number: WO 9201437

These statements have not been evaluated by the food and drug administration. The products mentioned are not intended to diagnose, treat, cure or prevent any disease. Always see your licensed health care professional for proper diagnosis and treatment.


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