Abstract
Background:
Hidradenitis suppurativa (HS) is a chronic inflammatory disease that disproportionally affects women, as well as Black and biracial individuals. While adalimumab remains the only therapy approved by the Food and Drug Administration for HS, many HS clinical trials for novel and re-tasked therapies are ongoing or upcoming. To optimize treatment equity, reflect the patient population and facilitate trial participation, it is important to elucidate aspects of clinical trial protocols that may systematically exclude specific patient groups or impose hardships.
Objective:
To systematically review inclusion and exclusion criteria as well as participant demographics in HS clinical trials.
Methods:
A literature search of PubMed, Embase, Cochrane Central, and Web of Science databases was conducted. Peer reviewed publications of randomized controlled trials that were written in English and had at least 10 participants were included. Title and abstract screening and data extraction were completed by two independent reviewers, with disagreements resolved by a third.
Results:
Twenty-three studies totaling 1,496 adult participants met the inclusion criteria. Race and ethnicity were not reported in 473/1,496 (31.6%) and 1420/1,496 (94.9%) trial participants, respectively. Trial participants were predominantly white (811/1023, 79.3%) and female (1057/1457, 72.5%). The median of each study’s average age was 35.7 years (IQR 33.5–38.0), and 17/23 (73.9%) trials excluded pediatric patients. Nearly all participants had Hurley Stage II (499/958, 52.0%) or Hurley Stage III (385/958, 40.2%) disease. Many trials excluded patients who were pregnant (19/23, 82.6%), breastfeeding (13/23, 56.5%), or had HS that was “too severe” (8/23, 34.8%) or “too mild” (16/23, 70.0%). Frequently, trial protocols required prolonged washout periods from HS therapies, relatively long duration in the study’s placebo arm, and prohibited concurrent analgesic use.
Conclusions:
This systematic review of 23 HS clinical trials totaling 1,496 participants identified substantial hardships imposed by trial participation, high rates of missing race and ethnicity data, and low representation of key patient groups, including those who identify as Black. Future trials with pragmatic study designs, broader inclusion criteria, and study sites in diverse communities may alleviate burdens of trial participation and improve enrollment of diverse patient groups.
Keywords: acne inversa; clinical trials; Hidradenitis Suppurativa; Diversity, Equity, and Inclusion
INTRODUCTION:
Hidradenitis suppurativa (HS) is a chronic, debilitating, inflammatory skin condition that disproportionately affects Black and biracial individuals. [1] Numerous trials for novel HS therapeutics are in the pipeline, signifying an urgent opportunity to develop trial protocols that facilitate inclusion of diverse participants. It remains unknown which aspects of trial protocols may impose hardships on participants, inadvertently leading to underrepresentation of key patient groups. This systematic review aims to characterize participant demographics and inclusion/exclusion criteria of published HS clinical trials to inform future HS trial designs.
MATERIALS AND METHODS:
This systematic review was registered in the International Prospective Register of Systematic Reviews (PROSPERO 2020 CRD42020162660) and followed the Preferred Reporting Items for Systematic Review and Meta-analysis reporting guideline [2]. Randomized controlled trials published in English in peer-reviewed journals with ≥10 participants with HS were included. A systematic search of PubMed, Embase, Cochrane Central, and Web of Science was conducted on 2/19/20 and updated 4/8/21 (Supplemental Materials, Appendix 1). Title/abstract screening and data extraction were completed by two independent authors and discrepancies were resolved by consensus.
RESULTS:
The literature search yielded 1,214 records and 23 studies eligible for analysis (Supplemental Table 1 and Supplemental Figure 1). Demographics of study participants are summarized in Table 1. Of the 23 studies, 22 reported sex, with 1057/1457 (72.5%) participants being female. Race was reported in 12 studies, totaling 811/1023 (79.3%) white participants and 157/1023 (15.3%) Black participants. Eight of the 11 studies missing race data were performed in Europe. Ethnicity data were available from three studies, with 14/76 (15.6%) participants identifying as Hispanic, Latino, or of Spanish origin. Eleven studies reported Hurley stage; 74/958 participants (7.7%) had Hurley stage I, 499/958 (52.0%) had Hurley stage II, and 385/958 (40.2%) had Hurley stage III disease. The youngest participant was 16 years old, and 17/23 studies explicitly excluded pediatric patients (Table 2). Additionally, 16 studies (69.6%) excluded patients whose HS was “too mild,” and 8 (34.8%) excluded patients whose HS was “too severe.” Pregnant women were excluded from 19/23 (82.6%) studies and breastfeeding women were excluded from 13/23 (56.5%). Other exclusion criteria included Human Immunodeficiency Virus (10/23 studies), congestive heart failure (10/23 studies), and history of internal malignancy (9/23 studies) (Supplemental Table 2).
Table 1.
Demographics of HS trial participants
| Study | Participants, n | Age, mean (SD); range | Female, n (%) | Race, n | Hurley Stage, n | BMI, mean (SD) | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| White | Black | Other | I | II | III | |||||
| Pioneer II [8] | 326 | 35.5 (11.2) | 221 (67.8) | 273 | 29 | 24 | 0 | 175 | 151 | 32.1 (7.7) |
| Pioneer I [8] | 307 | 37.0 (11.1) | 196 (63.8) | 234 | 62 | 11 | 0 | 161 | 146 | 33.8 (7.8) |
| Buimer et a l[9] | 200 | 31 (8); 18–52 | 180 (90.0) | -- | -- | -- | -- | -- | -- | -- |
| Kimball 2012[10,11] | 154 | 36.3 (11.8) | 110 (71.4) | 110 | 29 | 15 | 24 | 85 | 45 | 32.8a (--) |
| Jemec[12] | 46 | 32.5 (2.4); 27–37 | 39 (84.8) | 46b | 0b | 0b | -- | -- | -- | -- |
| Yildiz[13] | 43 | 35.7 (--); 20–55 | 25 (58.1) | -- | -- | -- | -- | -- | -- | 30.0 (--) |
| Wilden[14] | 43 | 38 (--); 23–57 | 31 (72.1) | -- | -- | -- | 7 | 23 | 13 | 37.1 (--) |
| Grant [15] | 38 | 33.5 (12.1); 16–61 | 26 (68.4) | 25 | 10 | 3 | -- | -- | -- | -- |
| Naouri[16] | 36 | 31.1 (8.5); 18–53 | 27 (75.0) | -- | -- | -- | -- | -- | -- | -- |
| Fajgenbaum[17] | 32 | 36 (--);-- | 30 (93.8) | 16d | 16 | 0 | -- | -- | -- | -- |
| Angel[18] | 31 | -- | -- | -- | -- | -- | -- | -- | -- | -- |
| Mortimer[19] | 24 | --; 20–44 | 24 (100.0) | -- | -- | -- | -- | -- | -- | -- |
| Andersen[20] | 24f | 35a (--); 27–49.5c | 16 (94.1) | 17f,h | 0 | 0 | 15 | 2 | 0 | 27.5a (22.8–32.5)c |
| Mahmoud[21,22] | 22 | 41 (--); 19–72 | 19 (86.4) | 10b | 11b | 1b | 0 | 22 | 0 | -- |
| Miller[23] | 21 | 39.1 (--) | 17 (81.0) | 21b | 0b | 0b | -- | -- | -- | 32.1 (--) |
| Adams [24] | 20 | 38.3 (--); 18–59 | 13 (65.0) | 20d | 0 | 0 | -- | -- | -- | 32.8 (--) |
| Tzanetakou[25] | 20g | 39.4 (12.8) | 9 (47.4)g | -- | -- | -- | 0 | 10 | 9 | 27.9 (5.9) |
| Kanni[26] | 20 | 48 (12.5) | 7 (35.0) | -- | -- | -- | 0 | 2 | 18 | 28.7 (5.9) |
| Vossen[27] | 20 | 35.1 (11.8) | 17 (85.0) | 19 | 0 | 1 | -- | -- | -- | 32.7 (6.2) |
| Grimstad[28] | 20 | 37.3(7.1)b | 17 (85.0) | 20b | 0b | 0b | 14 | 5 | 1 | 33.1 (6.7)b |
| Azim[29] | 20 | 29.7 (5); 20–35 | 11 (55.0) | -- | -- | -- | 10 | 10 | 0 | -- |
| Highton[30] | 18 | 34 (--); 17–50 | 15 (83.3) | -- | -- | -- | -- | -- | -- | -- |
| Fadel[31] | 11 | 27.1 (5.1); 17–35 | 7 (63.6) | -- | -- | -- | 4 | 4 | 2 | -- |
| Overall | 1496 | 35.7 (33.5–38.0) e | 1057/1457 (72.5%) | 811/1023 (79.3%) | 157/1023 (15.3%) | 55/1023 (5.4%) | 74/958 (7.7%) | 499/958 (52.0%) | 385/958 (40.2%) | 32.4 (29.7–32.9) e |
--: Not reported; BMI: Body Mass Index; Q1–Q3: Interquartile range
Median reported because mean was not available;
Obtained through personal correspondence with author;
Quartile 1 – Quartile 3;
Persons of Hispanic ethnicity were grouped with those of white race;
Median and interquartile range of each study’s mean;
17 of the 24 randomized participants were included in the final analysis;
19 of the 20 randomized participants were included in the final analysis;
All patients were reported to have Fitzpatrick Type II skin and were assumed to be of white race.
Table 2.
Requirements of HS Clinical Trial Protocols
| Study | Inclusion/Exclusion Criteria | Treatments Restrictions | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Age <18 years | Mild HS | Severe HS | Pregnancy | Breastfeeding | Analgesic Use | Antibiotic WO (days) | Biologic WO (days) | Placebo (weeks) | Offered active treatment | |
| Pioneer II [8] | ✕ | ✕ a | ✕ k | ✕ | ✕ | ✕ | 28o | 30 days or 5 half lives | 12–36 | ✕ |
| Pioneer I [8] | ✕ | ✕ a | ✕ k | ✕ | ✕ | ✕ | 28 | 30 days or 5 half lives | 12 | ✓ |
| Buimer et a l[9] | ✕ | ✕ b | ✓ | ✓ | ✓ | -- | -- | -- | NA | ✓ |
| Kimball 2012[10,11] | ✕ | ✕ c | ✓ | ✕ | ✕ | ✓ | 28o | NAp | 16 | ✓ |
| Jemec[12] | ✓ | ✓ | ✕ l | ✕ | ✕ | ✓ | 7 | -- | NA | ✓ |
| Yildiz[13] | ✕ | ✓ | ✓ | ✕ | ✓ | ✓ | -- | -- | NA | ✓ |
| Wilden[14] | ✕ | ✕ d | ✓ | ✓ | ✓ | ✕ | -- | 84 | 12 | ✓ |
| Grant[15] | ✕ | ✕ e | ✓ | ✕ | ✓ | ✓ | 14 | NAp | 8 | ✓ |
| Naouri[16] | ✕ | ✓ | ✕ l | ✕ | ✕ | -- | 90 | 180 | NA | ✓ |
| Fajgenbaum[17] | ✓ | ✕ f | ✓ | ✓ | ✓ | -- | NA | -- | NA | ✕ |
| Angel[18] | ✓ | ✕ g | ✓ | ✓ | ✓ | -- | -- | -- | 20 | ✕ |
| Mortimer[19] | ✕ | ✕ h | ✓ | ✕ | ✓ | -- | -- | 30q | NA | ✓ |
| Andersen[20] | ✕ | ✓ | ✕ l | ✕ | ✓ | ✕ | 28 | 28 | NA | ✓ |
| Mahmoud[21,22] | ✕ | ✕ i | ✕ l | ✕ n | ✕ | ✕ | 14n | 14n,q | NA | ✓ |
| Miller[23] | ✕ | ✕ i | ✓ | ✕ | ✕ | ✓ | 28 | 180 | 12 | ✕ |
| Adams[24] | ✕ | ✓ | ✓ | ✕ | ✓ | -- | -- | 30q | 12 | ✓ |
| Tzanetakou[25] | ✕ | ✕ i | ✓ | ✕ | ✕ | -- | -- | 180 | 12 | ✕ |
| Kanni[26] | ✓ | ✕ a | ✓ | ✕ | ✕ | -- | -- | -- | 12 | ✕ |
| Vossen[27] | ✕ | ✕ j | ✕ m | ✕ | ✓ | ✓ | 28 | 28 | 16 | ✕ |
| Grimstad[28] | ✕ p | ✕ p | ✓ | ✕ | ✕ | ✓ | 28n | NAq | 12 | ✓ |
| Azim[29] | ✕ | ✓ | ✕ l | ✕ | ✕ | ✕ | 14 | 14 | NA | ✓ |
| Highton[30] | ✓ | ✕ i | ✓ | ✕ | ✕ | -- | 14 | 14q | NA | ✓ |
| Fadel[31] | ✓ | ✓ | ✓ | ✕ | ✕ | ✓ | 14 | -- | NA | ✓ |
| Total, n (%) | 6 (26) | 7 (30) | 15 (65) | 4 (17) | 10 (43) | 8/14 (57) | 28 (14–28) r | 30 (28–84) r | 12 (12–16) r | 16 (70) |
WO: washout; ✓ Included/yes; ✕ Excluded/no; -- Not reported; NA Not applicable
Excluded Hurley Stage 1 and individuals with <3 abscesses and inflammatory nodules;
≥1 “active” lesion;
HS Physician Global Assessment (HS-PGA) ≥3;
≥3 abscesses or inflammatory nodules;
Hidradenitis Suppurativa Severity Index >8;
≥1 inflammatory nodule;
≥2 anatomic sites involved. All participants had previously failed antibiotics and local surgery;
Only included individuals with “moderate to severe” disease;
Excluded Hurley stage I disease;
≥4 inflammatory lesions in ≥2 anatomic locations and HS-PGA ≥3;
Excluded those with >20 draining fistulas;
Excluded Hurley stage III disease;
Excluded HS-PGA of severe or very severe;
Obtained through personal correspondence with authors;
Allowed oral tetracyclines at stable doses;
Excluded patients with any prior biologic use;
Biologics not routinely used to treat HS at the time of the study;
Median (Interquartile Range)
Many studies limited concurrent HS therapies during and prior to the study period (Table 2). The median time required for washout of systemic antibiotics was 28 days (IQR: 14–28). The median biologic washout period was 30 days (IQR: 28–84). Of three studies with biologic washout periods <30 days, two were conducted prior to routine use of biologics in HS. Further, 8/14 (57.1%) studies excluded participants taking analgesics at the time of inclusion. Time on placebo treatment ranged from 8 weeks to nearly 9 months, and 16/23 (69.7%) trials offered active therapy to all participants.
DISCUSSION:
This systematic review evaluated participant demographics and protocols of 23 HS trials encompassing 1,496 participants. Common practices included prolonged medication washout periods, long duration of placebo, and exclusion of analgesic use. These practices may increase the risk of poorly controlled inflammatory disease and pain, possibly contributing to disease progression.[3,4] Pragmatic study designs that minimize washout periods, allow concomitant analgesics, and incorporate active comparator control groups could alleviate these hardships imposed by trial participation (Table 3). Additional guidance from regulatory agencies may be necessary to expedite incorporation of such practices.
Table 3:
Summary of recommendations for improving representation in HS clinical trials
| Identified Gaps in HS Trials: | Proposed Steps for Mitigation: |
|---|---|
| 1. Medication washout periods contribute to poorly controlled disease and pain. |
|
| 2. Low racial and ethnic diversity |
|
| 3. Few studies with pediatric patients, Hurley Stage I disease, and pregnant individuals |
|
This systematic review also demonstrated low representation of key patient groups affected by HS, including Blacks, pediatric patients, pregnant and breastfeeding women, individuals living with HIV, and patients with very severe or mild HS disease. Although Blacks are approximately 2.5–3 times more likely to be affected by HS than white patients,[1] white patients comprised 79.3% of trial participants, similar to another recent review.[5] The true proportion of white participants is likely higher than reported, as 411/473 participants with missing race data were from European countries. Conducting HS trials in racially diverse settings may increase the representation of non-white individuals.
Pediatric patients and those with mild disease or very severe disease also had low representation in HS trials. Although the prevalence of HS among children in the United States is only 3.6-fold lower that of adults, [6] children comprise a much smaller proportion of trial participants than expected based on disease epidemiology. Similarly, only 6.5% of clinical trial participants had Hurley stage I disease, while Hurley stage I disease comprises approximately 65% of individuals living with HS worldwide. [7] Because HS often becomes increasingly recalcitrant to medical therapy over time, it is critical to develop treatments that are safe and effective for children and those with mild disease. [7]
Limitations of this study are that it included only English language publications and we were unable to obtain participant demographics for some studies despite attempting to contact authors.
CONCLUSION:
This systematic review demonstrates hardships imposed by HS trial participation and low representation of key patient groups such as persons who identify as Black, those with mild or very severe HS, children, pregnant and breastfeeding women, those requiring analgesia at baseline, and patients with medical comorbidities. Collaborations between patients, providers, industry, and regulatory agency stakeholders may help identify best practices for HS clinical trials as new therapies undergo evaluation.
Supplementary Material
Key Message:
HS clinical trial protocols impose hardships on participants and fail to enroll diverse patients.
Funding:
Lauren Anne Vigil Orenstein’s participation was be supported in part by the Building Interdisciplinary Research Careers in Women’s Health of the National Institutes of Health under Award Number K12HD085850. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Conflict of Interest Statements:
Lauren Anne Vigil Orenstein has been a consultant to ChemoCentryx, Incyte, and Novartis, participated in clinical trials with ChemoCentryx, and received grants from Pfizer.
John Robert Ingram is Editor-in-Chief of the British Journal of Dermatology and receives an authorship honorarium from UpToDate. He is a consultant for Boehringer Ingelheim, ChemoCentryx, Novartis and UCB Pharma and has served on advisory boards for Insmed, Kymera Therapeutics and Viela Bio. He is co-copyright holder of HiSQOL, Investigator Global Assessment and Patient Global Assessment instruments for HS.
Joslyn Kirby has been a speaker for AbbVie, advisory board participant for AbbVie, Incyte and consultant to AbbVie, Bayer, ChemoCentryx, Incyte, InflaRx, Janssen, Novartis, and UCB, and participated in clinical trials with AbbVie, ChemoCentryx, Incyte, InflaRx, Novartis, and UCB.
Samar Babikir Hasan has been a speaker for AbbVie and advisory board participant for UCB.
Other authors have no relevant conflicts to disclose.
Footnotes
Statement of Ethics: This retrospective review of patient data did not require ethical approval in accordance with local/national guidelines. Written informed consent from participants was not required in accordance with local/national guidelines.
Data Availability:
All data analyzed during this study are publically available or included in this article and/or its supplementary material files. Further enquiries can be directed to the corresponding author.
References
- 1.Garg A, Lavian J, Lin G, Strunk A, Alloo A. Incidence of hidradenitis suppurativa in the United States: A sex- and age-adjusted population analysis. J Am Acad Dermatol. 2017;77(1):118–22. [DOI] [PubMed] [Google Scholar]
- 2.Moher D, Liberati A, Tetzlaff J, Altman DG, Altman D, Antes G, et al. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. Vol. 6, PLoS Medicine. 2009. [PMC free article] [PubMed] [Google Scholar]
- 3.Garg A, Neuren E, Cha D, Kirby JS, Ingram JR, Jemec GBE, et al. Evaluating patients’ unmet needs in hidradenitis suppurativa: Results from the Global Survey Of Impact and Healthcare Needs (VOICE) Project. J Am Acad Dermatol. 2020;82(2):366–76. [DOI] [PubMed] [Google Scholar]
- 4.Marzano AV, Genovese G, Casazza G, Moltrasio C, Dapavo P, Micali G, et al. Evidence for a ‘window of opportunity’ in hidradenitis suppurativa treated with adalimumab: a retrospective, real-life multicentre cohort study*. Br J Dermatol. 2021;184(1):133–40. [DOI] [PubMed] [Google Scholar]
- 5.Price KN, Hsiao JL, Shi VY. Race and Ethnicity Gaps in Global Hidradenitis Suppurativa Clinical Trials. Vol. 237, Dermatology. 2021. p. 97–102. [DOI] [PubMed] [Google Scholar]
- 6.Mengesha YM, Holcombe TC, Hansen RC. Prepubertal hidradenitis suppurativa: Two case reports and review of the literature. Pediatr Dermatol. 1999;16(4):292–6. [DOI] [PubMed] [Google Scholar]
- 7.Canoui-Poitrine F, Le Thuaut A, Revuz JE, Viallette C, Gabison G, Poli F, et al. Identification of three hidradenitis suppurativa phenotypes: Latent class analysis of a cross-sectional study. J Invest Dermatol. 2013;133(6):1506–11. [DOI] [PubMed] [Google Scholar]
- 8.Kimball AB, Okun MM, Williams DA, Gottlieb AB, Papp KA, Zouboulis CC, et al. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. N Engl J Med. 2016;375(5):422–34. [DOI] [PubMed] [Google Scholar]
- 9.Buimer MG, Ankersmit MFP, Wobbes T, Klinkenbijl JHG. Surgical treatment of hidradenitis suppurativa with gentamicin sulfate: A prospective randomized study. Dermatologic Surg. 2008. Feb;34(2):224–7. [DOI] [PubMed] [Google Scholar]
- 10.Kimball AB, Kerdel F, Adams D, Mrowietz U, Gelfand JM, Gniadecki R, et al. Adalimumab for the treatment of moderate to severe hidradenitis suppurativa: A parallel randomized trial. Ann Intern Med. 2012;157(12):846–55. [DOI] [PubMed] [Google Scholar]
- 11.Scheinfeld N, Sundaram M, Teixeira H, Gu Y, Okun M. Reduction in pain scores and improvement in depressive symptoms in patients with hidradenitis suppurativa treated with adalimumab in a phase 2, randomized, placebo-controlled trial. Dermatol Online J. 2016;22(3). [PubMed] [Google Scholar]
- 12.Jemec GBE, Wendelboe P. Topical clindamycin versus systemic tetracycline in the treatment of hidradenitis suppurativa. J Am Acad Dermatol. 1998;39(6):971–4. [DOI] [PubMed] [Google Scholar]
- 13.Yildiz H, Senol L, Ercan E, Bilgili ME, Karabudak Abuaf O. A prospective randomized controlled trial assessing the efficacy of adjunctive hyperbaric oxygen therapy in the treatment of hidradenitis suppurativa. Int J Dermatol. 2016;55(2):232–7. [DOI] [PubMed] [Google Scholar]
- 14.Wilden S, Friis M, Tuettenberg A, Staubach-Renz P, Wegner J, Grabbe S, et al. Combined treatment of hidradenitis suppurativa with intense pulsed light (IPL) and radiofrequency (RF). J Dermatolog Treat. 2021;32(5):530–7. [DOI] [PubMed] [Google Scholar]
- 15.Grant A, Gonzalez T, Montgomery MO, Cardenas V, Kerdel FA. Infliximab therapy for patients with moderate to severe hidradenitis suppurativa: A randomized, double-blind, placebo-controlled crossover trial. J Am Acad Dermatol. 2010; [DOI] [PubMed] [Google Scholar]
- 16.Naouri M, Maruani A, Lagrange S, Cogrel O, Servy A, Collet Vilette AM, et al. Treatment of hidradenitis suppurativa using a long-pulsed hair removal neodymium:yttrium-aluminium-garnet laser: A multicenter, prospective, randomized, intraindividual, comparative trial. J Am Acad Dermatol. 2021;84(1):203–5. [DOI] [PubMed] [Google Scholar]
- 17.Fajgenbaum K, Crouse L, Dong L, Zeng D, Sayed C. Intralesional Triamcinolone May Not Be Beneficial for Treating Acute Hidradenitis Suppurativa Lesions: A Double-Blind, Randomized, Placebo-Controlled Trial. Dermatologic Surg. 2020;46(5):685–9. [DOI] [PubMed] [Google Scholar]
- 18.Angel MF, Ramasastry SS, Manders EK, Granfield D, Futress JW. Beneficial effects of staphage lysate in the treatment of chronic recurrent hidradenitis suppurativa. Surg Forum. 1987;38:111–2. [Google Scholar]
- 19.MORTIMER PS, DAWBER RPR, GALES MA, MOORE RA. A double-blind controlled cross-over trial of cyproterone acetate in females with hidradenitis suppurativa. Br J Dermatol. 1986;115(3):263–8. [DOI] [PubMed] [Google Scholar]
- 20.Lindsø Andersen P, Riis PT, Thorlacius L, Sigsgaard V, Nielsen CW, Chafranska L, et al. Intense pulsed light treatment for hidradenitis suppurativa: a within-person randomized controlled trial. Eur J Dermatology. 2020;30(6):723–9. [DOI] [PubMed] [Google Scholar]
- 21.Mahmoud BH, Tierney E, Hexsel CL, Pui J, Ozog DM, Hamzavi IH. Prospective controlled clinical and histopathologic study of hidradenitis suppurativa treated with the long-pulsed neodymium:yttrium-aluminium-garnet laser. J Am Acad Dermatol. 2010;62(4):637–45. [DOI] [PubMed] [Google Scholar]
- 22.Tierney E, Mahmoud BH, Hexsel C, Ozog D, Hamzavi I. Randomized control trial for the treatment of hidradenitis suppurativa with a neodymium-doped yttrium aluminium garnet laser. Dermatologic Surg. 2009;35(8):1188–98. [DOI] [PubMed] [Google Scholar]
- 23.Miller I, Lynggaard CD, Lophaven S, Zachariae C, Dufour DN, Jemec GBE. A double-blind placebo-controlled randomized trial of adalimumab in the treatment of hidradenitis suppurativa. Br J Dermatol. 2011;165(2):391–8. [DOI] [PubMed] [Google Scholar]
- 24.Adams DR, Yankura JA, Fogelberg AC, Anderson BE. Treatment of hidradenitis suppurativa with etanercept injection. Arch Dermatol. 2010;146(5):501–4. [DOI] [PubMed] [Google Scholar]
- 25.Tzanetakou V, Kanni T, Giatrakou S, Katoulis A, Papadavid E, Netea MG, et al. Safety and efficacy of anakinra in severe hidradenitis suppurativa a randomized clinical trial. JAMA Dermatology. 2016;152(1):52–9. [DOI] [PubMed] [Google Scholar]
- 26.Kanni T, Argyropoulou M, Spyridopoulos T, Pistiki A, Stecher M, Dinarello CA, et al. MABp1 Targeting IL-1α for Moderate to Severe Hidradenitis Suppurativa Not Eligible for Adalimumab: A Randomized Study. J Invest Dermatol. 2018;138(4):795–801. [DOI] [PubMed] [Google Scholar]
- 27.Vossen ARJV, van Doorn MBA, van der Zee HH, Prens EP. Apremilast for moderate hidradenitis suppurativa: Results of a randomized controlled trial. J Am Acad Dermatol. 2019;80(1):80–8. [DOI] [PubMed] [Google Scholar]
- 28.Grimstad Ø, Kvammen BØ, Swartling C. Botulinum Toxin Type B for Hidradenitis Suppurativa: A Randomised, Double-Blind, Placebo-Controlled Pilot Study. Am J Clin Dermatol [Internet]. 2020;21(5):741–8. Available from: 10.1007/s40257-020-00537-9 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 29.Abdel Azim AA, Salem RT, Abdelghani R. Combined fractional carbon dioxide laser and long-pulsed neodymium : yttrium-aluminium-garnet (1064 nm) laser in treatment of hidradenitis suppurativa; a prospective randomized intra-individual controlled study. Int J Dermatol. 2018. Sep 1;57(9):1135–44. [DOI] [PubMed] [Google Scholar]
- 30.Highton L, Chan WY, Khwaja N, Laitung JKG. Treatment of hidradenitis suppurativa with intense pulsed light: A prospective study. Plast Reconstr Surg. 2011;128(2):459–65. [DOI] [PubMed] [Google Scholar]
- 31.Fadel MA, Tawfik AA. New topical photodynamic therapy for treatment of hidradenitis suppurativa using methylene blue niosomal gel: A single-blind, randomized, comparative study. Clin Exp Dermatol. 2015;40(2):116–22. [DOI] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
All data analyzed during this study are publically available or included in this article and/or its supplementary material files. Further enquiries can be directed to the corresponding author.