J Clin Aesthet Dermatol. 2024;17(5):30–33
by Raj Chovatiya, MD, PhD, MSCI*; Meredith Tyree Polaskey, MS*; Edward Lain, MD; Todd Schlesinger, MD; Heather Woolery-Llloyd, MD; Patrick Burnett, MD; and Diane Hanna, DNP
*Dr. Chovatia and Ms. Polaskey share co-first authorship of this article.
Dr. Chovatiya is a Clinical Associate Professor at the Rosalind Franklin University of Chicago Medical School and is the Founder and Director of the Center for Medical Dermatology and Immunology Research in Chicago, Illinois. Ms. Polaskey is with the Department of Dermatology at Northwestern University Feinberg School of Medicine in Chicago, Illinois. Dr. Lain is with Sanova Dermatology and the Austin Institute for Clinical Research in Austin, Texas. Dr. Schlesinger is with the Dermatology and Laser Center of Charleston and Clinical Research Center of the Carolinas in Charleston, South Carolina. Dr. Woolery-Llloyd is with Dr. Phillip Frost’s Department of Dermatology and Cutaneous Surgery at University of Miami’s Miller School of Medicine in Miami, Florida. Drs. Hanna and Burnett are with Arcutis Biotherapeutics, Inc. in Westlake Village, California.
FUNDING: No funding was provided for this article.
DISCLOSURES: Drs. Hanna and Burnett are employees of Arcutis Biotherapeutics, Inc. EL has served as an investigator, advisor, consultant, and/or speaker for AbbVie, Eli Lilly and Company, Bristol Myers Squibb, Ortho Dermatologics, Pfizer Inc, Sanofi, Regeneron, Galderma, Dermavant, Incyte, UCB, and Journey. Dr. Schlesinger has served as a consultant, speaker and/or investigator for AbbVie, Arcutis, Boehringer-Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Eli Lilly and Company, Galderma, Janssen, Novartis, Pfizer Inc., UCB. Dr. Woolery-Llloyd has served as a consultant, speaker, and/or investigator for Ortho Dermatologics, L’Oréal, Eli Lillly and Company, Incyte, Pfizer Inc., Galderma, Allergan, Arcutis, Vyne, Eirion, and Regeneron Dr. Chovatiya has served as an advisory board member, consultant, and/or investigator for AbbVie, Apogee Therapeutics, Arcutis, Argenx, ASLAN Pharmaceuticals, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, Eli Lilly and Company, FIDE, Galderma, Genentech, Incyte, Janssen, LEO Pharma, L’Oréal, Nektar Therapeutics, Novan, Inc., Opsidio, Pfizer Inc., Regeneron, RAPT, Sanofi, and UCB. Dr. Polaskey has no conflicts of interest relevant to this article.
ABSTRACT: Seborrheic dermatitis (SD) is a chronic inflammatory skin condition that commonly involves the scalp, and thus, affects a diverse demographic with varying hair care needs. Current SD treatments are limited based on optimized formulation, efficacy, adverse events, and lack of placebo-controlled trials. A novel roflumilast foam formulation has emerged as a promising therapeutic option optimally designed for use on the scalp and other hair-bearing areas. We conducted a comprehensive assessment of beauty industry standards, confirming the foam formulation’s alignment with industry guidelines and exclusion of potentially harmful ingredients. In addition, consultation with an expert dermatologist panel yielded a strong endorsement, underscoring a high level of confidence in prescribing the foam across diverse hair and skin types. Keywords: Seborrheic dermatitis
Introduction
Seborrheic dermatitis (SD) is a chronic inflammatory skin condition marked by erythematous, scaly plaques with a distinctive yellow or white “greasy” scale appearance. While this condition can affect individuals across all demographics, certain hair care practices can exacerbate its severity. For example, regimens that include the use of chemical relaxers and hair extensions may inadvertently worsen symptoms.1 These considerations are particularly relevant when addressing the condition in diverse populations across a spectrum of hair types, highlighting the need for versatile and gentle treatment options.
The current therapeutic landscape for SD is diversified but not without drawbacks. Topical antifungals, while a cornerstone of SD management, commonly cause skin irritation, burning, and/or dryness.2,3 Moreover, the efficacy of antifungal shampoos may be influenced by hair washing frequencies, which are often dictated by hair type and texture and can range from daily to intervals of several weeks.4 Topical corticosteroids, another mainstay, come with the risk of adverse effects such as atrophy, telangiectasias, dyschromia, and systemic absorption with long-term use. Topical calcineurin inhibitors minimize some of these adverse events, but their chronic use has been tempered by overall limited efficacy and side effects of burning, stinging, and a controversial risk profile that includes lymphoma.5 The off-label use of the first-generation topical phosphodiesterase-4 (PDE4) inhibitor crisaborole (currently approved only for atopic dermatitis), while reportedly effective for some, causes application site pain for 14 to 32 percent of users.6 Similarly, the infrequent off-label use of oral apremilast, a PDE4 inhibitor currently approved only for psoriasis, has been linked to gastrointestinal symptoms, headache, and other side effects.7 These concerns highlight a pressing need for novel therapies that can effectively manage SD while minimizing side effects.
The introduction of roflumilast foam, recently approved by the FDA in December 2023 for treatment of seborrheic dermatitis in individuals aged 9 years or older, represents a significant advancement in the management of this chronic, burdensome inflammatory disease. Roflumilast, a selective inhibitor of PDE4, exhibits a binding affinity exceeding that of crisaborole and apremilast by a factor of between 25- to over 300-fold.8 Roflumilast foam demonstrates remarkable efficacy in alleviating key signs and symptoms of seborrheic dermatitis, with nearly 80 percent of patients achieving complete or nearly complete clearance by Week 8. Additionally, it maintains a favorable safety and tolerability profile, as evidenced by its low rates of application site reactions.6
The formulation of roflumilast foam aims to maintain hair integrity while effectively delivering the therapeutic agent to the skin, especially hair-bearing areas such as the scalp. Yet, any formulation has the potential to interfere with the natural properties of hair, particularly across individuals with diverse skin types. To ensure the formulation meets the needs of all hair types for managing SD, we undertook a comprehensive review of beauty industry standards and consulted with an expert dermatologist panel composed of leading medical and cosmetic dermatologists with expertise in formulation. The formulation has received a robust endorsement from this board and aligns with established industry standards, affirming its status as a safe and effective treatment option for all hair types in the management of seborrheic dermatitis.
Product Formulation and Testing
Roflumilast foam, designed as a water-based formulation, excludes fragrances and known irritants and sensitizers. Its formulation is balanced to further minimize skin irritation by matching the natural pH of the stratum corneum, employing a low water concentration per dose, and utilizing scalp-targeted application methods with balanced emollients. Moreover, the foam’s composition includes ingredients that ensure its suitability for a wide variety of skin and hair types.
A key component of the formulation is Crodafos CES emulsifying wax, serving as the primary non-active ingredient responsible for the foam’s structure. Crodafos CES is a mild emulsifier and conditioning agent used in the cosmetic industry. Crodafos CES has an unusually high Krafft temperature, which was found to play a crucial role in inhibiting micelle formation at normal skin temperatures including bathing. This property prevents the deposition of negative charges on hair fibers, a common problem with typical surfactants that can increase hair’s electrostatic charge and exacerbate frizz. The inhibition of micelle formation by Crodafos CES leads to its repulsion from innately negatively charged hair strands, enabling the foam to target the scalp effectively without adhering to the hair.9 Additionally, its inclusion in the formulation aids in reducing lag time, allowing the medication to penetrate the skin more quickly after application.10
Crodafos CES is utilized in the hair care industry due to its ability to enhance color retention and minimize cuticle damage during chemical treatments.11 Its integration across a diverse range of products, from dyes and shampoos to relaxers, underscores its versatility and effectiveness across various hair types and textures. Currently, Crodafos CES is an ingredient in at least 56 hair color and bleaching products, four hair treatment/serum products, and six styling gel/lotion products, many of which are designed specifically to cater to the needs of diverse curl patterns (Table 1).
Industry Standards and Expert Opinion
The beauty industry is closely attuned to ingredients beneficial or harmful to hair health. Leveraging their expertise in identifying hair-friendly ingredients, we wanted to ensure that the formulation of roflumilast foam aligned with this sector’s established standards. By evaluating the foam formulation against these standards, we aimed to assess its compatibility and safety for various hair types.
Building on this understanding, our assessment focused on ingredient categories cautioned against by the beauty industry due to their potential to adversely affect hair and skin health (Table 2). Sulfates, such as sodium lauryl sulfate (SLS) and sodium laureth sulfate (SLES), are often highlighted for their potential to cause hair dryness, due at least in part to their low Krafft temperature.12,13 The roflumilast foam formulation utilizes Transcutol, a highly purified form of diethylene glycol monoethyl ether (DEGEE), offering a gentler alternative without the risk of dryness and irritation.14 Similarly, dyes and preservatives are frequently discouraged by the industry due to their propensity for causing skin irritation and allergic reactions.15–20 The industry advises caution with certain thickening agents and alcohols, which can affect hair moisture and color,19 and fragrances, known for their risk of color stripping and skin irritation.21 Essential oils warrant caution due to their potential to trigger allergic contact dermatitis and alter hair color.22,23 Oxidizing agents such as hydrogen peroxide, bromates, and persulfates are known to break down natural hair color and can distort the color of dyed hair.24 Retinyl palmitate is associated with photosensitization and irritation, including peeling, scaling, itching, burning, and redness.25 Our comprehensive evaluation confirmed that the roflumilast foam formulation excludes ingredients recognized by the beauty industry as harmful to hair health.
The formulation was further reviewed by a diverse expert panel comprising nine dermatologists and scholars from medical centers, dermatology clinics, and academic institutions across the United States. Their collective expertise in clinical practice, research, and dermatological innovation provided a comprehensive perspective on the formulation’s compatibility with hair and skin health. Through a detailed feedback and voting process, the experts aligned with the beauty industry’s standards on ingredient safety. Board experts independently supported many of the beauty industry’s guidelines on ingredients to avoid in foam products given potential skin impact – particularly in regard to dyes, preservatives, and irritants.
Upon review of formulation data and corresponding beauty industry standards, eight out of nine experts expressed feeling “extremely confident” about prescribing roflumilast foam to patients of diverse skin and hair types, including patients with previous hair treatments. This strong endorsement was anchored in the formulation’s adherence to beauty industry guidelines, specifically its exclusion of harmful ingredients, alongside the well-established use of ingredients like Crodafos CES in hair and skin care products.
Conclusion
The alignment of roflumilast foam’s formulation with beauty industry standards and its validation by an expert dermatologist panel underscore its suitability for a diverse range of hair and skin types in the management of seborrheic dermatitis. The panel’s thorough review, which echoed the beauty industry’s emphasis on potentially harmful ingredients, reinforces the foam formulation’s safety profile. Ultimately, this novel foam emerges as a promising therapeutic option, offering effective and safe management of SD by leveraging familiar ingredients to enable the reliable delivery of a well-studied medication.
References
- Rucker Wright D, Gathers R, Kapke A, et al. Hair care practices and their association with scalp and hair disorders in African American girls. J Am Acad Dermatol. 2011;64(2):253–262.
- Danby FW, Maddin WS, Margesson LJ, et al. A randomized, double-blind, placebo-controlled trial of ketoconazole 2% shampoo versus selenium sulfide 2.5% shampoo in the treatment of moderate to severe dandruff. J Am Acad Dermatol. 1993;29(6):1008–1012.
- Lebwohl M, Plott T. Safety and efficacy of ciclopirox 1% shampoo for the treatment of seborrheic dermatitis of the scalp in the US population: Results of a double-blind, vehicle-controlled trial. Int J Dermatol. 2004;43(Supp. 1):17–20.
- Hollins LC, Butt M, Hong J, et al. Research in Brief: Survey of hair care practices in various ethnic and racial pediatric populations. Pediatr Dermatol. 2022;39(3):494–496.
- Lam M, Zhu JW, Tadrous M, et al. Association between Topical Calcineurin Inhibitor Use and Risk of Cancer, including Lymphoma, Keratinocyte Carcinoma, and Melanoma: A Systematic Review and Meta-analysis. JAMA Dermatology. 2021;157(5):549–558.
- Zirwas MJ, Draelos ZD, Dubois J, et al. Efficacy of Roflumilast Foam, 0.3%, in Patients with Seborrheic Dermatitis: A Double-blind, Vehicle-Controlled Phase 2a Randomized Clinical Trial. JAMA Dermatology. 2023;159(6):613–620.
- Langley A, Beecker J. Management of common side effects of apremilast. J Cutan Med Surg. 2018;22(4):415–421.
- Dong C, Virtucio C, Zemska O, et al. Treatment of skin inflammation with benzoxaborole phosphodiesterase inhibitors: Selectivity, cellular activity, and effect on cytokines associated with skin inflammation and skin architecture changes. J Pharmacol Exp Ther. 2016;358(3):413–422.
- Osborne DW, Berk D. Treatment of Skin Conditions Using High Krafft Temperature Anionic Surfactants. Published online 2021:1–31.
- Osborne DW. Method and Formulation for Improving Roflumilast Skin Penetration Lag Time. Published online 2019:1–10.
- Obukowho P, Gallagher K, Pereira AG, et al. Emulsifying System. Published online 2007:1–7.
- Howell Jr. MC. 17 Dangerous Ingredients to Avoid in Hair Care Products. Accessed November 10, 2023. https://www.consumernotice.org/products/dangerous-hair-care-ingredients/
- Prajapati RR, Bhagwat SS. Effect of foam boosters on Krafft temperature. J Chem Eng Data. 2012;57(3):869–874.
- Osborne DW, Musakhanian J. Skin Penetration and Permeation Properties of Transcutol®—Neat or Diluted Mixtures. AAPS PharmSciTech. 2018;19(8):3512–3533.
- Mukkanna KS, Stone NM, Ingram JR. Para-phenylenediamine allergy: Current perspectives on diagnosis and management. J Asthma Allergy. 2017;10:9–15.
- Schmidt JD, Johansen JD, Nielsen MM, et al. Immune responses to hair dyes containing toluene-2,5-diamine. Br J Dermatol. 2014;170(2):352–359.
- De Groot AC. Side-effects of henna and semi-permanent “black henna” tattoos: A full review. Contact Dermatitis. 2013;69(1):1–25.
- Lee HS, Lin YW. Permeation of hair dye ingredients, p-phenylenediamine and aminophenol isomers, through protective gloves. Ann Occup Hyg. 2009;53(3):289–296.
- Stone CA, Liu Y, Relling M V., et al. Immediate Hypersensitivity to Polyethylene Glycols and Polysorbates: More Common Than We Have Recognized. J Allergy Clin Immunol Pract. 2019;7(5):1533–1540.e8.
- Deza G, Giménez-Arnau AM. Allergic contact dermatitis in preservatives: Current standing and future options. Curr Opin Allergy Clin Immunol. 2017;17(4):263–268.
- Schneller-Pavelescu L, Ochando-Ibernón G, Silvestre-Salvador JF. An Update on Fragrance Contact Dermatitis. Curr Treat Options Allergy. 2019;6(1):92–102.
- Sarkic A, Stappen I. Essential oils and their single compounds in cosmetics-a critical review. Cosmetics. 2018;5(1):1–21.
- Keller E. Aromatherapy Handbook for Beauty, Hair, and Skin Care. Healing Arts Press. 1999.
- Alessandrini A, Piraccini BM. Essential of hair care cosmetics. Cosmetics. 2016;3(34):1–10.
- Sorg O, Kuenzli S, Saurat JH. Side Effects and Pitfalls in Retinoid Therapy. In: Vahlquist A, Duvic M, eds. Basic and Clinical Dermatology. Informa Healthcare USA, Inc.; 2007:225–248.
Putting the Formulation Back in Foam: Optimizing Seborrheic Dermatitis Treatment Across Diverse Hair Types
by Raj Chovatiya, MD, PhD, MSCI*; Meredith Tyree Polaskey, MS*; Edward Lain, MD; Todd Schlesinger, MD; Heather Woolery-Llloyd, MD; Patrick Burnett, MD; and Diane Hanna, DNP
*Dr. Chovatia and Ms. Polaskey share co-first authorship of this article.
Dr. Chovatiya is a Clinical Associate Professor at the Rosalind Franklin University of Chicago Medical School and is the Founder and Director of the Center for Medical Dermatology and Immunology Research in Chicago, Illinois. Ms. Polaskey is with the Department of Dermatology at Northwestern University Feinberg School of Medicine in Chicago, Illinois. Dr. Lain is with Sanova Dermatology and the Austin Institute for Clinical Research in Austin, Texas. Dr. Schlesinger is with the Dermatology and Laser Center of Charleston and Clinical Research Center of the Carolinas in Charleston, South Carolina. Dr. Woolery-Llloyd is with Dr. Phillip Frost’s Department of Dermatology and Cutaneous Surgery at University of Miami’s Miller School of Medicine in Miami, Florida. Drs. Hanna and Burnett are with Arcutis Biotherapeutics, Inc. in Westlake Village, California.
FUNDING: No funding was provided for this article.
DISCLOSURES: Drs. Hanna and Burnett are employees of Arcutis Biotherapeutics, Inc. EL has served as an investigator, advisor, consultant, and/or speaker for AbbVie, Eli Lilly and Company, Bristol Myers Squibb, Ortho Dermatologics, Pfizer Inc, Sanofi, Regeneron, Galderma, Dermavant, Incyte, UCB, and Journey. Dr. Schlesinger has served as a consultant, speaker and/or investigator for AbbVie, Arcutis, Boehringer-Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Eli Lilly and Company, Galderma, Janssen, Novartis, Pfizer Inc., UCB. Dr. Woolery-Llloyd has served as a consultant, speaker, and/or investigator for Ortho Dermatologics, L’Oréal, Eli Lillly and Company, Incyte, Pfizer Inc., Galderma, Allergan, Arcutis, Vyne, Eirion, and Regeneron Dr. Chovatiya has served as an advisory board member, consultant, and/or investigator for AbbVie, Apogee Therapeutics, Arcutis, Argenx, ASLAN Pharmaceuticals, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, Eli Lilly and Company, FIDE, Galderma, Genentech, Incyte, Janssen, LEO Pharma, L’Oréal, Nektar Therapeutics, Novan, Inc., Opsidio, Pfizer Inc., Regeneron, RAPT, Sanofi, and UCB. Dr. Polaskey has no conflicts of interest relevant to this article.
ABSTRACT: Seborrheic dermatitis (SD) is a chronic inflammatory skin condition that commonly involves the scalp, and thus, affects a diverse demographic with varying hair care needs. Current SD treatments are limited based on optimized formulation, efficacy, adverse events, and lack of placebo-controlled trials. A novel roflumilast foam formulation has emerged as a promising therapeutic option optimally designed for use on the scalp and other hair-bearing areas. We conducted a comprehensive assessment of beauty industry standards, confirming the foam formulation’s alignment with industry guidelines and exclusion of potentially harmful ingredients. In addition, consultation with an expert dermatologist panel yielded a strong endorsement, underscoring a high level of confidence in prescribing the foam across diverse hair and skin types. Keywords: Seborrheic dermatitis
Introduction
Seborrheic dermatitis (SD) is a chronic inflammatory skin condition marked by erythematous, scaly plaques with a distinctive yellow or white “greasy” scale appearance. While this condition can affect individuals across all demographics, certain hair care practices can exacerbate its severity. For example, regimens that include the use of chemical relaxers and hair extensions may inadvertently worsen symptoms.1 These considerations are particularly relevant when addressing the condition in diverse populations across a spectrum of hair types, highlighting the need for versatile and gentle treatment options.
The current therapeutic landscape for SD is diversified but not without drawbacks. Topical antifungals, while a cornerstone of SD management, commonly cause skin irritation, burning, and/or dryness.2,3 Moreover, the efficacy of antifungal shampoos may be influenced by hair washing frequencies, which are often dictated by hair type and texture and can range from daily to intervals of several weeks.4 Topical corticosteroids, another mainstay, come with the risk of adverse effects such as atrophy, telangiectasias, dyschromia, and systemic absorption with long-term use. Topical calcineurin inhibitors minimize some of these adverse events, but their chronic use has been tempered by overall limited efficacy and side effects of burning, stinging, and a controversial risk profile that includes lymphoma.5 The off-label use of the first-generation topical phosphodiesterase-4 (PDE4) inhibitor crisaborole (currently approved only for atopic dermatitis), while reportedly effective for some, causes application site pain for 14 to 32 percent of users.6 Similarly, the infrequent off-label use of oral apremilast, a PDE4 inhibitor currently approved only for psoriasis, has been linked to gastrointestinal symptoms, headache, and other side effects.7 These concerns highlight a pressing need for novel therapies that can effectively manage SD while minimizing side effects.
The introduction of roflumilast foam, recently approved by the FDA in December 2023 for treatment of seborrheic dermatitis in individuals aged 9 years or older, represents a significant advancement in the management of this chronic, burdensome inflammatory disease. Roflumilast, a selective inhibitor of PDE4, exhibits a binding affinity exceeding that of crisaborole and apremilast by a factor of between 25- to over 300-fold.8 Roflumilast foam demonstrates remarkable efficacy in alleviating key signs and symptoms of seborrheic dermatitis, with nearly 80 percent of patients achieving complete or nearly complete clearance by Week 8. Additionally, it maintains a favorable safety and tolerability profile, as evidenced by its low rates of application site reactions.6
The formulation of roflumilast foam aims to maintain hair integrity while effectively delivering the therapeutic agent to the skin, especially hair-bearing areas such as the scalp. Yet, any formulation has the potential to interfere with the natural properties of hair, particularly across individuals with diverse skin types. To ensure the formulation meets the needs of all hair types for managing SD, we undertook a comprehensive review of beauty industry standards and consulted with an expert dermatologist panel composed of leading medical and cosmetic dermatologists with expertise in formulation. The formulation has received a robust endorsement from this board and aligns with established industry standards, affirming its status as a safe and effective treatment option for all hair types in the management of seborrheic dermatitis.
Product Formulation and Testing
Roflumilast foam, designed as a water-based formulation, excludes fragrances and known irritants and sensitizers. Its formulation is balanced to further minimize skin irritation by matching the natural pH of the stratum corneum, employing a low water concentration per dose, and utilizing scalp-targeted application methods with balanced emollients. Moreover, the foam’s composition includes ingredients that ensure its suitability for a wide variety of skin and hair types.
A key component of the formulation is Crodafos CES emulsifying wax, serving as the primary non-active ingredient responsible for the foam’s structure. Crodafos CES is a mild emulsifier and conditioning agent used in the cosmetic industry. Crodafos CES has an unusually high Krafft temperature, which was found to play a crucial role in inhibiting micelle formation at normal skin temperatures including bathing. This property prevents the deposition of negative charges on hair fibers, a common problem with typical surfactants that can increase hair’s electrostatic charge and exacerbate frizz. The inhibition of micelle formation by Crodafos CES leads to its repulsion from innately negatively charged hair strands, enabling the foam to target the scalp effectively without adhering to the hair.9 Additionally, its inclusion in the formulation aids in reducing lag time, allowing the medication to penetrate the skin more quickly after application.10
Crodafos CES is utilized in the hair care industry due to its ability to enhance color retention and minimize cuticle damage during chemical treatments.11 Its integration across a diverse range of products, from dyes and shampoos to relaxers, underscores its versatility and effectiveness across various hair types and textures. Currently, Crodafos CES is an ingredient in at least 56 hair color and bleaching products, four hair treatment/serum products, and six styling gel/lotion products, many of which are designed specifically to cater to the needs of diverse curl patterns (Table 1).
Industry Standards and Expert Opinion
The beauty industry is closely attuned to ingredients beneficial or harmful to hair health. Leveraging their expertise in identifying hair-friendly ingredients, we wanted to ensure that the formulation of roflumilast foam aligned with this sector’s established standards. By evaluating the foam formulation against these standards, we aimed to assess its compatibility and safety for various hair types.
Building on this understanding, our assessment focused on ingredient categories cautioned against by the beauty industry due to their potential to adversely affect hair and skin health (Table 2). Sulfates, such as sodium lauryl sulfate (SLS) and sodium laureth sulfate (SLES), are often highlighted for their potential to cause hair dryness, due at least in part to their low Krafft temperature.12,13 The roflumilast foam formulation utilizes Transcutol, a highly purified form of diethylene glycol monoethyl ether (DEGEE), offering a gentler alternative without the risk of dryness and irritation.14 Similarly, dyes and preservatives are frequently discouraged by the industry due to their propensity for causing skin irritation and allergic reactions.15–20 The industry advises caution with certain thickening agents and alcohols, which can affect hair moisture and color,19 and fragrances, known for their risk of color stripping and skin irritation.21 Essential oils warrant caution due to their potential to trigger allergic contact dermatitis and alter hair color.22,23 Oxidizing agents such as hydrogen peroxide, bromates, and persulfates are known to break down natural hair color and can distort the color of dyed hair.24 Retinyl palmitate is associated with photosensitization and irritation, including peeling, scaling, itching, burning, and redness.25 Our comprehensive evaluation confirmed that the roflumilast foam formulation excludes ingredients recognized by the beauty industry as harmful to hair health.
The formulation was further reviewed by a diverse expert panel comprising nine dermatologists and scholars from medical centers, dermatology clinics, and academic institutions across the United States. Their collective expertise in clinical practice, research, and dermatological innovation provided a comprehensive perspective on the formulation’s compatibility with hair and skin health. Through a detailed feedback and voting process, the experts aligned with the beauty industry’s standards on ingredient safety. Board experts independently supported many of the beauty industry’s guidelines on ingredients to avoid in foam products given potential skin impact – particularly in regard to dyes, preservatives, and irritants.
Upon review of formulation data and corresponding beauty industry standards, eight out of nine experts expressed feeling “extremely confident” about prescribing roflumilast foam to patients of diverse skin and hair types, including patients with previous hair treatments. This strong endorsement was anchored in the formulation’s adherence to beauty industry guidelines, specifically its exclusion of harmful ingredients, alongside the well-established use of ingredients like Crodafos CES in hair and skin care products.
Conclusion
The alignment of roflumilast foam’s formulation with beauty industry standards and its validation by an expert dermatologist panel underscore its suitability for a diverse range of hair and skin types in the management of seborrheic dermatitis. The panel’s thorough review, which echoed the beauty industry’s emphasis on potentially harmful ingredients, reinforces the foam formulation’s safety profile. Ultimately, this novel foam emerges as a promising therapeutic option, offering effective and safe management of SD by leveraging familiar ingredients to enable the reliable delivery of a well-studied medication.
References