Patient Satisfaction and Adverse Effects Following the use of Topical Hair Fiber Fillers.

Introduction: Alopecia (hair loss) commonly affects patients and can severely affect one's confidence and self-esteem. In addition to medical therapy, hair filler fibers can improve the gross appearance of thinning hair in a targeted manner by making hair appear fuller and thicker. The objective of this study is to assess patient use, satisfaction, and adverse effects following the application of a commercially available hair fiber filler product. Materials and
Methods: This cross-sectional study was conducted at an academic tertiary dermatology center. Alopecia patients were supplied a keratin hair fiber filler, which best matched their natural hair color. Following 90 days of application, patients were asked to complete questionnaires to assess patient satisfaction and record patient-reported adverse events.
Results: Twenty women and 20 men with hair loss participated. Patients reported improved hair volume and increased perceptions of confidence and attractiveness after applying fiber. Most subjects (92.5%) reported a high level of satisfaction with the fiber's ability to match hair color and provide sufficient coverage. No serious adverse effects were reported.
Conclusion: Alopecia has a negative impact on quality of life and several psychological domains. Topical hair filler fiber can serve as an effective and safe camouflage for patients with alopecia with high user satisfaction. Copyright:

INTRODUCTION

Disturbances to the pilosebaceous unit can ultimately lead to alopecia (hair loss), a common and distressing chief complaint about many patients.[1] For both men and women, hair loss can be accompanied by substantial psychological distress, thus severely affecting one's confidence and self-esteem, whether they have scarring or nonscarring alopecia. A study in 40 subjects with alopecia areata and 40 age- and sex-matched controls determined the prevalence of depression (P = 0.008), anxiety (P = 0.003), and neuroticism (P = 0.05) were significantly higher compared to controls.[2]

Despite the high prevalence of hair loss, only a select number of treatment options with proven safety and efficacy are available. These treatment modalities infrequently achieve complete regrowth and require lengthy, indefinite use to achieve their desired clinical result.[3] A companion hair fiber filler product can serve as a temporary yet effective solution for scalp hair thinning.

Hair fiber fillers may comprise wool or rice keratin, rayon, or human hair and require the application to areas with existing hairs to bind successfully.[2] In studies, negatively charged vellus hairs on the scalp strongly bind positively charged particles found in hair fiber products to create thicker, fuller-looking hair.[4] Specific scalp areas of concern can be targeted with fiber to provide patients with coverage that improves their appearance. Evidence of positive patient outcomes and safety can be used to promote the use of filler products, thus improving alopecia treatment outcomes, as well as patient satisfaction with treatment. The objective of this cross-sectional study was to examine patient satisfaction and possible adverse effects following the use of a commercially available hair fiber filler product.

MATERIALS AND METHODS

This cross-sectional study was approved by the University of California, Irvine Institutional Review Board. Alopecia patients were recruited from a single, academic, tertiary dermatologic practice in Southern California and supplied with a hair filler fiber product for daily use (12 g x 3 bottles) (Toppik™, Church and Dwight, Ewing Township, NJ, USA). Fiber color was matched to patients' current hair color from a selection from 10 available shades, including black, light brown, medium brown, dark brown, light blonde, medium blonde, dark blonde, auburn, gray, and white. After 90 days of topical fiber application at the patients' discretion, patients were asked to complete six questionnaires to assess satisfaction and possible adverse effects (patient satisfaction [0-5], self-assessment [0-7], physician assessment [0-3], patient assessment [0-3], patient experience [a-f], and patient scalp sensitivity [yes/no]) [Appendix Tables 1-6]. Data were pooled and analyzed using nonparametric statistical methods.

Appendix Table 1

Patient satisfaction after 3 months applying a commercially available hair filler fiber producta

Patient satisfaction
Using the scale outlined below, please answer the following questions:
0. Nonapplicable
1. Strongly disagree
2. Disagree
3. Unsure
4. Agree
5. Strongly agree
10. Was the product easy to use?
11. Does the product wash off easily when you want it to?
12. Do you feel that your hair loss is less noticeable when using this product?
13. Did this product meet your expectations?
14. Do you feel that your overall appearance with the product is better than without the product?
15. Do you feel more confident using the product?
16. Would you keep using the product?
17. Would you recommend it to a friend?
18. Overall product rating?

Appendix Table 6

Patient scalp sensitivity after 3 months applying a commercially available hair filler fiber product

Patient scalp sensitivity Please answer the following questions as best you can
1. Does your scalp feel itching, prickling, tightness, pain, or burning with sun?
a. Yes
b. No
2. Does your scalp feel itching, prickling, tightness, pain, or burning with heat?
a. Yes
b. No
3. Does your scalp feel itching, prickling, tightness, pain, or burning with air dryness?
a. Yes
b. No
4. Does your scalp feel itching, prickling, tightness, pain, or burning with wind?
a. Yes
b. No
5. Does your scalp feel itching, prickling, tightness, pain, or burning with humidity?
a. Yes
b. No
6. Does your scalp feel itching, prickling, tightness, pain, or burning with exercise?
a. Yes
b. No
7. Does your scalp feel itching, prickling, tightness, pain, or burning with stress?
a. Yes
b. No
8. Does your scalp feel itching, prickling, tightness, pain, or burning with alcohol?
a. Yes
b. No
9. Does your scalp feel itching, prickling, tightness, pain, or burning with hot beverages?
a. Yes
b. No
10. Does your scalp feel itching, prickling, tightness, pain, or burning with spices?
a. Yes
b. No

RESULTS

The study recruited 40 subjects (20 men, 20 women) with confirmed by review of electronic medical record alopecia diagnosis. The most common filler colors used included shades of brown (55%), black (22.5%), blonde (17.5%), and gray (5%). A total of 92.5% of the patients were satisfied that the fibers accurately matched their hair color. The fiber product was easy to use, with most patients reporting application time was <5 min (87.5%).

Rates of patient satisfaction were high, and questionnaire results were strongly supportive of the use of hair fiber products [Shown in Table 1]. Subjects provided a superior overall product rating, in addition to expressing a strong interest to continue their use of the filler and recommending it to others. The filler had a positive impact on perceptions of confidence and overall appearance and successful coverage of hair loss [Shown in Figures 1 and 2].

Table 1

Patient satisfaction after 90 days applying a commercially available hair filler fiber product

Patient satisfaction
Using the scale outlined below, please answer the following questions from 1 (strongly disagree) to 5 (strongly agree)
	Mean	Median (minimum-maximum)	SD
1. Was the product easy to use?	4.4	5 (2-5)	0.807
2. Does the product wash off easily when you want it to?	4.3	4 (1-5)	0.797
3. Do you feel that your hair loss is less noticeable when using this product?	4.6	5 (3-5)	0.590
4. Did this product meet your expectations?	4.3	4 (2-5)	0.790
5. Do you feel that your overall appearance with the product is better than without the product?	4.5	5 (1-5)	0.877
6. Do you feel more confident using the product?	4.5	5 (1-5)	0.847
7. Would you keep using the product?	4.4	5 (1-5)	0.955
8. Would you recommend it to a friend?	4.5	5 (2-5)	0.784
9. Overall product rating?	4.4	4 (2-5)	0.672

SD – Standard deviation

Figure 1

Filler fiber application results in clinically significant scalp coverage. Application of commercially available, matching, black hair fiber filler product to the frontal scalp (a – before, b – after), and scalp vertex (c – before, d – after) of a male patient with androgenetic alopecia

Figure 2

Patient-reported improvement in hair fullness and self-confidence. The majority of the patients reported increased overall hair volume, as well as perception of personal attractiveness and confidence after 90 days of fiber use on a scale of 1 (greatly decrease), 2 (moderately decreased), 3 (slightly decreased), 4 (unsure), 5 (slightly increase), 6 (moderately increase), and 7 (greatly increased)

Physician assessments conducted to identify contact or irritant adverse effects demonstrated only one case of erythema. There was no reported scalp erythema, scaling, and pustules in 39/40 patients. Overall, 90% of the patients did not report itching, prickling, tightness, pain, or burning during and after fiber use. Exceptions appeared to be connected with concomitant lifestyle exacerbating factors such as exercise (n = 4), heat exposure (n = 3), and exposure to one of each: dry air, wind, stress, spicy food, and alcohol. No serious adverse events were reported.

DISCUSSION

The hair fiber filler supplied to patients is commercially available and made of keratin fibers. The fibers are permanently colored with the use of diverse color palettes to provide optimal color matching and satisfaction.

The high frequency of positive outcomes with the use of hair fibers was pleasantly surprising. Seventy-eight percent of patients with self-reported hair loss use some type of camouflaging agent and use hair fibers prevalently (59%).[5] Prior studies have shown hair fiber filler to be an effective solution to hair loss with improved scalp appearance, self-esteem, and quality of life.[6] Neither the fiber nor their color processing has resulted in irritation or adverse effects even if used over a lengthy period of time. No prior studies have described adverse events associated with fiber use. Hair filler fibers are a safe and effective camouflage method for patients suffering from alopecia. The fact that the fibers contain color still presents a risk, particularly if they have paraphenylenediamine (PPD). PPD is one of the most common scalp allergens, as per recent studies.[7]

Treatment modalities that promote hair regrowth and prevent further hair loss are employed in both mild and severe cases of alopecia. Topical minoxidil and oral, 5α-reductase inhibitor finasteride are the only current Food and Drug Administration-approved therapies for alopecia. The need for indefinite use and the absence of complete regrowth with these modalities leaves a lot to be desired.[8]

Patients with less severe or patchy hair loss may favor the use of physical camouflages, including hair extensions or topical hair filler fibers that may provide the desired scalp coverage.[2] However, hair extensions that attach directly to existing scalp hair have been associated with the development of traction alopecia.[9] Wefted or net foundation wigs are commonly considered when exploring options to conceal severe cases of hair loss but can present a high monetary burden.[4]

If patients wish for a more permanent treatment option, surgical hair transplants or micropigmentation are options.[1011] While surgical methods have proven to be long lasting and allow the use of one's own hair, resulting in a more natural look, hair transplantation can be costly and risk possible infection or scar formation at the donor site(s).[210] Micropigmentation uses standard cosmetic tattooing instruments inserting pigment in the upper dermis to create the image of hair follicles in areas affected by alopecia.[1213] Advantages of this procedure include long-lasting results, a close resemblance to natural follicles, and it can be combined with hair transplantation to disguise scalp scars.[214] Important risks to consider include allergy to the pigment, the need for the dye to accurately match natural hair pigment, and the requirement for “touch-ups” over time due to fading and hair loss progression.[2]

This study was limited by a small patient cohort at a single, academic medical site and potential for survey or recall bias from self-reporting patients. It is reassuring that in this small study, observed adverse events are minimal; one patient had mild erythema of the scalp after 90 days of fiber use. There is no downtime associated with fiber use, unlike surgical procedures. Topical hair filler fibers can be used quickly, on demand to conceal areas of thinning hair, and can help boost confidence and reduce the significant psychological harm that has been shown to accompany hair loss.

CONCLUSION

Alopecia has a negative impact on quality of life and several psychological domains.[15] Topical hair filler fiber can effectively improve the appearance of hair thinning and can be used in conjunction with medical or surgical therapies to visually augment hair thickness. Patients were satisfied with the obtained scalp coverage and appearance of thicker, fuller-looking hair and the consistency to which the fiber blended with their natural hair color. Physicians treating hair loss should be aware and able to inform patients about the availability and use of topical fibers in an effort to decrease alopecia-associated morbidity. Further large-scale, long-term studies should be conducted to assess the continued use of filler products, their long-term impact on patients' perception of appearance and self-esteem as an adjunct to other treatment options.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

Appendix Tables 2

Self-assessment after 3 months applying a commercially available hair filler fiber product

Self-assessment
Please review each of the parameters below and select the most appropriate answer:
1. Greatly decreased
2. Moderately decreased
3. Slightly decreased
4. Unsure
5. Slightly increase
6. Moderately increase
7. Greatly increased
1. Overall hair volume
2. Scalp coverage
3. Thickness of hair body
4. Softness of hair
5. Hair quality
6. Hair fullness
7. Personal attractiveness
8. Confidence

Appendix Tables 3

Clinical assessment of contact dermatitis and/or adverse events after 3 months applying a commercially available hair filler fiber product

Clinical assessment of contact dermatitis and/or adverse events
Please review each of the parameters below and select the most appropriate grade: 0 (no reaction), 1 (marginal reaction), 2 (distinct erythema) or 3 (strong, deep erythema which may extend beyond the treatment site)
1. Visual assessment of erythema
2. Visual assessment of scaling
3. Visual assessment of pustules

Appendix Tables 4

Patient assessment of contact dermatitis and/or adverse events after 3 months applying a commercially available hair filler fiber product

Patient assessment of contact dermatitis and/or adverse events
Please review each of the parameters below and select the most appropriate grade: 0 (no reaction), 1 (marginal reaction), 2 (distinct erythema) or 3 (strong, deep erythema which may extend beyond the treatment site)
4. Visual assessment of erythema
5. Visual assessment of scaling
6. Visual assessment of pustules

Appendix Tables 5

Patient experience after 3 months applying a commercially available hair filler fiber product

Patient experience Please answer the following questions as best you can
1. On average, how much time was required to apply the hair fiber product?
a. Less than a min
b. 1-3 min
c. 3-5 min
d. >5 min
2. What is the best description of the length of your hair?
a. Above the chin
b. Level with the chin
c. Level with shoulders
d. Past shoulders
3. What best describes your hair color?
a. Black
b. Brown
c. Blonde
d. Auburn
e. Gray
f. Other
4. Were you happy that the Toppik hair-building fibers matched your hair color?
a. Yes
b. No