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What are Clinically-Proven Hair Regrowth and Scalp Health Products?
Scientific clinical proof requires independent clinical investigators who publish the study results regardless of the outcome (positive or negative). For publication of results in a reputable journal, the clinical results are sent to a medical journal. The journal editors then have the manuscript review by two or more experts in the field. Only after their review is the article accepted for publication. Even this does not imply acceptance of the claims. Only after other medical researchers confirm these results are the results accepted as valid.
What about the claims on other "hair growth" products?
Many hair products say they are "clinically proven", yet there is no evidence that there ever have been any actual clinical studies. We have often asked sellers of such products for copies of such studies but have never received a reply to this request. It is more likely that there are no studies.
The FDA has estimated that 300,000 hair growth remedies have been marketed in the United States. Yet only a handful of these have rigorous, published scientific proof that they help hair growth, or hair health or scalp health.
Can an inactive product grow hair? YES!
First, all the studies minoxidil found a high level of hair growth in the placebo group which was about 55% of the effect with minoxidil. The power of the human mind is such that placebo pills often cures diseases nearly as well as an effective pharmaceutical drug. This is why placebo controls are so important.
Second, since men increase hair growth from winter to summer in the Northern hemisphere, virtually any inactive factor tested in this time period, without placebo controls, will give even more "evidence" of hair growth. Just the action of applying a placebo to the hair every day often produces measurable hair growth. Finally, skin irritants such as dinitrobenzene, or just plucking our hair, can induce significant hair growth but produce serious skin damage.
On the other hand, some scientists are of the opinion that there is no true placebo effect with minoxidil if all variables are carefully accounted for. They find that better measurements eliminate any placebo effect for minoxidil.1
Many marketing groups have been selling "hair stimulating" products for years. Yet, they never fund any independent tests of their product. And no papers are on their product are ever published in respectable, peer-reviewed journals. In reality, they have no "hair stimulating" product.
There are only three major types of products that help reverse pattern baldness which are supported by independent scientific research: These are:
- Minoxidil (Rogaine) and minoxidil-like agents
- DHT blockers such as finasteride (Propecia) and anti- androgens
- kin repair and hair growth agents based on copper-peptides or retinoic acid
A number of other drugs and natural products are sold with hair growth claims but lack evidence of efficacy. These include:
- Anti-inflammatory agents
- Other commonly used remedies
Minoxidil
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Minoxidil, developed by the Upjohn Company as Rogaine, works in part by partially enlarging miniaturized follicles and reversing the miniaturization process. This prolongs the growth phase of the hair cycle, allowing the hair to become longer and thicker. With more follicles in the growth phase at the same time, it is possible to see improved coverage of the scalp. Although the growth phase may be prolonged, the follicle will continue to cycle. Several cycles may be necessary before maximum potential hair regrowth can be achieved.
Minoxidil works best for adults experiencing gradually thinning hair or gradual hair loss on top of the head. Rogaine is for men or women with hair loss or thinning that begins at the top of the scalp (Vertex) and where there is a family history of gradual thinning hair or gradual hair loss.
Minoxidil is applied before going to bed and again in the morning. It takes about 4 months of twice-daily treatment before initial results are noticeable. Initial results can include less hair shedding and some new hair growth. The newly regrown hairs may be finer and substantially less pigmented than other full size hairs, however many of these hairs will enlarge and darken as they grow out. After about 12 months of minoxidil use, the maximum benefit is usually achieved, and hair regrowth tends to stabilize.
If minoxidil treatment is discontinued for several months, the regrown hairs will probably be shed, and hair loss will resume. Minoxidil is sold in a solution of water, alcohol, and propylene glycol.
Clinical Results with 2% Minoxidil
For hair counts in minoxidil studies, marks are made on a specific area on the scalp and all of the non-vellus hairs (hairs thicker and darker than "peach fuzz") were counted at the start of the trial, and then again after a period of time. Pinpoint tattoos are made on the scalp of the subjects to mark the measurement areas and assure that they are exactly the same for both counts.
Male subject hair count increases (1" diameter circle):
| New hairs (p<.0005) | Placebo |
Rogaine |
| 4 months | 39 |
72 |
| 12 months | - |
112 |
Female subject vellus hair count increases (1 square centimeter):
| Study 1 - USA / New hairs (p<.0004) | Placebo |
Rogaine |
| 8 months | 11.0 |
22.7 |
| Study 1 - International / New hairs (p<.0001) | Placebo |
Rogaine |
| 8 months | 19.1 |
19.1 |
Comment on placebo effect and hair studies: Although the subjects being studied knew that they had only a 50% chance of receiving the real minoxidil, many believed that they are the ones who are getting the real thing, and they expected results. Thus, they grew more hair! The placebo effect demonstrates the remarkable power of the human mind, even for such seemingly uncontrollable conditions as stopping hair loss and regrowing hair.
Other clinical studies of minoxidil (Rogaine brand) used 4 categories of hair regrowth to describe observed effectiveness of minoxidil when compared to the placebo lotion:
- None: No visible regrowth
- Minimal: Barely discernible regrowth
- Moderate: Readily discernible regrowth
- Dense: Full regrowth similar to non-thinning areas
Male subject: Self-evaluation of hair growth
4 months of Placebo |
4 months of Rogaine |
4 months of Rogaine? |
None = 68% |
None = 42% |
None = 16% |
| Minimal - 31% | Minimal - 32% | Minimal - 36% |
| Moderate - 9% | Moderate - 24% | Moderate - 40% |
| Dense - 2% | Dense - 2% | Dense - 8% |
Total = 100% |
Total = 100% |
Total = 100% (p<.0005) |
Other clinical studies at 27 US medical centers involving over 2,300 patients concluded that minoxidil increases hair growth in both men and women.
Clinical Studies with 5% Rogaine - Minoxidil
Upjohn has continued its minoxidil development and tested a 5% minoxidil solution (Rogaine Extra Strength) which is approved by the FDA for treating hair loss. Ronald Trancik, Ph.D, from Pharmacia & Upjohn presented data on 5% Minoxidil at the American Association of Dermatology in March, 1998. In a 120 week study of 5% Minoxidil, hair growth continued until the end of the study. In two other studies using hair count and photographic assessment, the following results were shown:
Pharmacia & Upjohn 1998 Minoxidil Study - Hair Growth Results
Moderate / Dense |
Minimal |
No Change |
Loss of Hair |
Unknown |
|
| 5% Minoxidil | 30% |
24% |
29% |
6% |
11% |
| 2% Minoxidil | 15% |
23% |
47% |
1% |
13% |
| Placebo | 7% |
22% |
61% |
na |
na |
These results are on the crown area of the head where Minoxidil has the best effect and not on the front. The most common side effects of 5% minoxidil are scalp itch and irritation. It is available over the counter at about $18 to $29 per month. Some report improved results with the simultaneous use of Propecia and/or 0.025% retinoic acid (Retin-A).
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Limitations and Side Effects of Minoxidil
Some people get benefit from minoxidil, others don't. It seems to work better in women than in men. Minoxidil is much better at helping people retain and improve the hair they still have than in growing new hair.
In people with fine hair, the combination of regrowth plus "deminiaturization" of the existing hair can provide an acceptable cosmetic result about 40-50% of the time. As a bonus, most of these people stop getting balder.
Common cutaneous adverse reactions included erythema, scaling, pruritus, and dermatitis.
Mechanism of Action of Minoxidil
Cutaneous blood flow is decreased in pattern baldness and minoxidil increases cutaneous blood flow to the scalp, possibly promoting hair growth by this mechanism. However, other vasodilators do not grow hair.
The stumptailed macaque is a superior animal model for studying pattern baldness. They have balding patterns similar to that in humans. Balding begins shortly after puberty occurs in nearly all macaques including females. Uno et al. demonstrated that minoxidil activated resting follicles in the balding scalp inducing follicular enlargement and preventing progression of balding. When treatment was discontinued, all beneficial effects were reversed, and balding progressed.
The figure to the left was developed from Uno's meticulous research on the effect of minoxidil through various phases of the hair cell cycle in rat models. Both sets of figures start at T or teleogen. The minoxidil treated skin produces larger hair follicles. It should be emphasized that effects in humans are not this dramatic.
In a 1996 paper Uno reported that that topical minoxidil induced an increased rate of DNA synthesis in follicular cells in early anagen but not in nonfollicular cells such as fibrocytes or epidermal keratinocytes. Minoxidil induced a significant increase in DNA synthesis in all follicule cells in a dose-specific manner. They suggest that minoxidil has a specific affinity to hair follicular cells and induced their cell proliferation. Recently, researchers at L'Oreal suggested that minoxidil works by activating PGHS 1 (prostaglandin endoperoxide synthase-1) which helps promote hair growth.2
Minoxidil-like Drugs - Aminexil (Dercap)
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Aminexil (Dercap) is an antifibrosis molecule that is related to minoxidil. This treatment, developed by L'Oreal's Vichy labs, was tested on 130 men and 160 women. It was reported that the daily use of Aminexil for 6 weeks increased hair growth in men by 8%. In clinical study of the women, 66% of women experienced a decrease of hair loss and over 80% reported stronger, thicker hair. The L'Oreal groups posits that hair loss is linked to the accelerated aging of the roots, characterized by fibrosis, which stiffens the roots and compresses the blood vessels that nourish the follicles and deprives them of adequate nourishment. This causes the roots to weaken and damages the follicle. Aminexil is felt to counter the aging process. The cost is about about $42 for a 6 week supply and $11 for Aminexil containing-shampoo.
If the L'Oreal theory is correct, it may also explain the hair promoting actions of copper-peptides (See: SRCPs and Hair Regrowth Agents) which have angiogenic properties which stimulate new blood vessel formation which may restore hair follicle nutrition.
Update - Good Results with Aminexil (Dercap) and Copper Peptides
At Skin Biology, a significant number of our customers have reported exceptionally strong hair growth when using both copper-peptides and Aminexil. These people report that this gives much better hair growth than does minoxidil.
Minoxidil-like drugs - Cromakalim / BRL 34915
Cromakalim / BRL 34915 is a potassium (K+) channel opener used in the treatment of heart conditions. Research indicates that works similarly to minoxidil. Upjohn has patented it for potential treatment of hair loss. It stimulates potassium channel conductance and stimulates DNA synthesis in mouse epidermal keratinocyte and whole hair follicle cultures.
Minoxidil-like Drugs - Diazoxide (Hyperstat IV, Proglycem)
Diazoxide (Hyperstat IV, Proglycem) is an anti-hypertensive, potassium channel blocker, that has a positive effect on hair loss. It is reported to produces minimal to moderate hair growth and is FDA approved for lowering blood pressure. It is expensive and must be specially formulated for topical use.
Minoxidil-like Drugs - Pinacidil
Pinacidil and a close analog PC-1075 are anti-hypertensive drugs and potassium channel blockers similar to minoxidil. They have been reported to stimulate hair growth when applied topically. It is in clinical testing.
