untitled Reliability and Validity of a Photographic Method for Measuring Facial Hair Density in Men M any studies have investigated hair removal orgrowth prevention treatments, but they of-ten measure hair density using noninvasive methods that are subjective and qualitative.1 Although photographic and digital hair-counting methods have been used, their reliability and validity remain unknown.2 We describe a simple, noninvasive method of hair counting used in a hair growth prevention treatment trial and as- sess its reliability and validity. Methods. The data are from the first 14 healthy men con- secutively enrolled in a randomized, double-blinded, pla- cebo-controlled trial of a topical agent for hair growth prevention. Eligible subjects were required to shave at least once daily to avoid a beard with hair length visible above the skin line and to have a baseline physician global assessment (PGA) score for hair density of 4 or 5 in the beard area. The PGA was developed by us for the larger clinical trial as a visual analog scale for rating hair den- sity by overall impression (Figure). Subjects were randomized as to which side of their face would receive drug or placebo, which was then applied once daily after shaving to a treatment area within the beard region in a split-face design (Figure). The duration of ac- tive treatment was 6 or 8 weeks; subjects were assessed every 2 or 4 weeks for up to 8 to 16 weeks. Subjects did not shave for 48 hours prior to each visit so that they would have enough visible hair for assessment. At each visit, the PGA and digital photography of the treatment areas were performed (Figure). The study was approved by the Uni- versity of Pennsylvania institutional review board. Two of us ( J.W. and J.M.S.) independently counted hairs in all photographs to assess interrater reliability (Figure). Five months after the initial measurement, hairs were recounted in all photographs to assess test-retest reliability. We used the intraclass correlation coefficient (ICC) and Spearman � correlation to assess reliability. Construct validity was evaluated by comparing hair counts with respect to corresponding PGA ratings using the t test. We conservatively estimated a sample size of 100 photographs with 85% power to detect an ICC of 0.6, as- suming null ICC of 0.4 and � = 0.05. Results. The median age of the subjects was 28 years (in- terquartile range [IQR], 26-38 years). Eleven subjects were white (79%), and 3 were Asian (21%). All subjects had brown or black hair. A total of 130 photographs were ob- tained. Hair counts were approximately normally dis- tributed, ranging from 2 to 391. The subject PGA scores were available for 114 photographs and ranged from 2 to 5 (median, 4; IQR, 4-4). Test-retest reliability dem- onstrated an ICC of 0.90 (95% confidence interval [CI], 0.86-0.93) and a Spearman � of 0.88 (95% CI, 0.84- 0.92). Interrater reliability demonstrated an ICC of 0.81 (95% CI, 0.74-0.86) and a Spearman � of 0.81 (95% CI, 0.75-0.87). In the validity analysis, we included only PGA scores for which there were at least 10 corresponding pho- tographs. Photographs with a PGA score of 3 had a lower mean hair count (mean [SD] count, n = 195.0 [16.5]) than those with PGA score of 4 (mean [SD] count, n = 237.2 [5.8]) (P = .003). Comment. Our hair counting method demonstrates ex- cellent interrater and intrarater reliability as well as con- struct validity based on its ability to discriminate catego- ries of a PGA.3 In contrast to other methods, our approach does not require expensive or specialized equipment. It provides better quantification of hair changes than global assessment scales, which may be too qualitative for clini- cal trials.1 Moreover, it is less tedious and labor inten- sive than the manual collection, counting, and weigh- ing of hair.4 Although automated methods such as the TrichoScan (TRICHOLOG GmbH, Freiburg, Germany) have reported high reliability, fully automated ap- proaches are hindered by imperfect algorithms, which can lead to inaccuracy.1,5 Component Procedure Treatment area Using clear transparencies, templates with a cutout of the treatment area with its pre-specified size and shape (2.5 centimeter diameter circle in this study) were constructed. Templates also contained the outline of an anatomic landmark (earlobe, angle of the jaw, and jaw line of the left or right side of the face in this study) in order to maintain consistency of the treatment area (beard region in this study) each time. Templates were used for both drug application and clinical evaluation. With the template in place, the investigator performed a PGA of the treatment area according to the following indications: With the template in place, digital photographs of the treatment area were taken with flash (Nikon D70S and SB-400, Nikon Corporation, Tokyo, Japan) at a prespecified distance (12 inches in this study) from the area. No special lighting conditions were required; photographs were obtained under fluorescent overhead lighting in the patient examination rooms of a dermatology clinic. Photographs were pooled, randomized, and viewed by blinded investigators at 100% magnification using imaging software (Photoshop CS4, Adobe Corp, San Jose, CA). Using the software “count tool” to mark and keep count of each hair, the total number of hairs at least 1 millimeter long within follicles located in the target area was counted. Hair lengths were measured using the software “ruler” function. Multiple hairs growing from the same follicular unit were considered to be 1 hair. Digital photographs and hair counts Physical global assessment (PGA) of hair density Very dense5 Dense4 Moderately dense3 Very sparse1 Total alopecia0 Sparse2 Figure. Protocol for hair density assessments. The image herein is copyrighted by the University of Pennsylvania, Philadelphia, and is reproduced with permission. ARCH DERMATOL/ VOL 147 (NO. 11), NOV 2011 WWW.ARCHDERMATOL.COM 1328 ©2011 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ by a Carnegie Mellon University User on 04/05/2021 We recognize several limitations. First, hair diameter and length were not evaluated. Second, the camera was not mounted, and the skin in the treatment areas was not marked so as to guarantee the same exact evaluation dis- tance and site every time. The generalizability of our re- sults to areas with different hair density or to people with darker skin is unknown. Finally, additional studies are required to determine if this technique is responsive to true changes in hair density and to compare this method to other approaches such as digital photodermoscopy. Nevertheless, our simple, noninvasive method of hair counting demonstrates excellent reliability and discrimi- nation validity and deserves further evaluation as an as- sessment tool for hair removal or growth prevention studies. Accepted for Publication: July 10, 2011. Author Affiliations: Departments of Dermatology (Mss Wan and Steinemann and Drs Abuabara, Kurd, Musiek, Vittorio, and Gelfand) and Internal Medicine (Drs Abuabara and Kurd) and Center for Clinical Epidemiol- ogy and Biostatistics (Dr Gelfand), University of Penn- sylvania Perelman School of Medicine, Philadelphia; and Philadelphia VA Medical Center, Philadelphia (Dr Musiek). Dr Musiek is now with the Department of Der- matology, Washington University, St Louis, Missouri; Ms Steinemann is now with Drexel University College of Medi- cine, Philadelphia. Correspondence: Dr Gelfand, 1471 Penn Tower, One Convention Avenue, Philadelphia, PA 19104 (Joel.Gelfand @uphs.upenn.edu). Author Contributions: Ms Wan and Dr Gelfand had full access to all of the data in the study and take responsi- bility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Abuabara, Kurd, Vittorio, and Gelfand. Acquisition of data: Wan, Abuabara, Musiek, Steinemann, Gelfand. Analysis and interpreta- tion of data: Wan and Gelfand. Drafting of the manu- script: Wan. Critical revision of the manuscript for impor- tant intellectual content: Wan, Abuabara, Kurd, Musiek, Steinemann, Vittorio, and Gelfand. Statistical analysis: Wan and Gelfand. Obtained funding: Vittorio and Gelfand. Administrative, technical, and material support: Wan, Abuabara, and Kurd. Study supervision: Musiek, Vittorio, and Gelfand. Financial Disclosure: Dr Vittorio has filed a patent ap- plication for the use of DNA polymerase inhibitors in in- ducing alopecia. Dr Gelfand served as consultant and in- vestigator with Abbott, Amgen, Centocor, Genentech, Novartis, and Pfizer; consultant with Celgene, Co- vance, Galderma, Shire Pharmaceuticals, and Wyeth; and investigator with Shionogi. Funding/Support: This study was supported in part by grants from the Department of Dermatology at the Uni- versity of Pennsylvania (Dr Vittorio), the Edwin and Fan- nie Gray Hall Center for Human Appearance at the Uni- versity of Pennsylvania (Dr Vittorio), National Institutes of Health training grant T32-AR07465 (Ms Wan and Dr Musiek), and the Doris Duke Clinical Research Fellow- ship (Dr Abuabara). Role of the Sponsors: The sponsors had no role in the design and conduct of the study; in the collection, analy- sis, and interpretation of data; or in the preparation, re- view, or approval of the manuscript. Additional Contributions: Jennifer Goldfarb, RN, Albana Oktrova, and Debbie Leahy, LPN, did an out- standing job coordinating the clinical trial associated with this study. 1. Chamberlain AJ, Dawber RP. Methods of evaluating hair growth. Australas J Dermatol. 2003;44(1):10-18. 2. Hamzavi I, Tan E, Shapiro J, Lui H. A randomized bilateral vehicle- controlled study of eflornithine cream combined with laser treatment versus laser treatment alone for facial hirsutism in women. J Am Acad Dermatol. 2007; 57(1):54-59. 3. Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979;86(2):420-428. 4. Price VH, Menefee E, Strauss PC. Changes in hair weight and hair count in men with androgenetic alopecia, after application of 5% and 2% topical mi- noxidil, placebo, or no treatment. J Am Acad Dermatol. 1999;41(5, pt 1):717- 721. 5. Van Neste D, Trüeb RM. Critical study of hair growth analysis with computer- assisted methods. J Eur Acad Dermatol Venereol. 2006;20(5):578-583. VIGNETTES Connubial Androgenetic Alopecia Report of a Case. We report herein the case of a 52-year- old, postmenopausal Hispanic woman who developed se- vere androgenetic alopecia following involuntary expo- sure to topical testosterone gel used by her spouse for the treatment of hypogonadism. The patient presented to our clinic with complaints of a 1-year history of hair loss. Results of the pull test were negative; physical ex- amination revealed severe hair thinning involving the crown and the frontotemporal regions. Dermoscopy of the scalp revealed more than 20% hair diameter varia- tion. No other signs of hyperandrogenism were identi- fied, such as hirsutism, acne, or obesity. Diagnosis of an- drogenetic alopecia with Hamilton pattern was established based on the clinical and dermoscopic findings. Owing to the abrupt onset and Hamilton pattern, a laboratory workup was performed to exclude endocrine abnormalities. The results revealed high levels of testos- terone (146 ng/dL; normal. 2-45 ng/dL; to convert tes- tosterone to nanomoles per liter, multiply by 0.0347) and free testosterone (22.7 pg/mL; normal, 0.2-5.0 pg/mL). To exclude ovarian malignant neoplasm, abdominal and transvaginal ultrasonograms were obtained. The find- ings were normal. Further investigation into the patient’s history re- vealed that her spouse had started using a topical testos- terone gel (containing 1% testosterone) 18 months pre- viously for the treatment of hypogonadism. He had been applying the topical testosterone once daily (5-g packet) to his upper arm. Joy Wan, BA Katrina Abuabara, MD, MA Shanu K. Kurd, MD, MSCE Amy Musiek, MD Jane M. Steinemann, BA Carmela C. Vittorio, MD Joel M. Gelfand, MD, MSCE ARCH DERMATOL/ VOL 147 (NO. 11), NOV 2011 WWW.ARCHDERMATOL.COM 1329 ©2011 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ by a Carnegie Mellon University User on 04/05/2021