This is the current release of the guideline.

To present guidelines on the management and treatment of adult and childhood psoriasis with topical therapies

Children and adults with psoriasis and psoriatic arthritis

Management/Treatment

1. Topical corticosteroids
2. Vitamin D analogues, including combination calcipotriene/betamethasone propionate ointment
3. Tazarotene
4. Tacrolimus and pimecrolimus
5. Other topical treatments
   • Emollients
   • Salicylic acid
   • Anthralin
   • Coal tar
6. Combination of topical therapies

An evidence-based model was used and evidence was obtained using a search of the MEDLINE database spanning the years 1960 through 2008.

Not stated

Evidence was graded using a 3-point scale based on the quality of methodology as follows:

1. Good-quality patient-oriented evidence
2. Limited-quality patient-oriented evidence
3. Other evidence including consensus guidelines, opinion, or case studies

The available evidence was evaluated using a unified system called the Strength of Recommendation Taxonomy developed by editors of the U.S. family medicine and primary case journals (i.e., American Family Physician, Family Medicine, Journal of Family Practice, and British Medical Journal [BMJ] USA). This strategy was supported by a decision of the Clinical Guidelines Task Force in 2005 with some minor modifications for a consistent approach to rating the strength of the evidence of scientific studies.

A work group of recognized psoriasis experts was convened to determine the audience for and scope of the guidelines and to identify clinical questions to structure the primary issues in diagnosis and management of psoriasis. Work groups completed a disclosure of commercial support.

Clinical recommendations were developed on the best available evidence tabled in the guideline.

In those situations where documented evidence-based data are not available, the authors have utilized expert opinion to generate the clinical recommendations. Prior guidelines on psoriasis were also evaluated.

A formal cost analysis was not performed and published cost analyses were not reviewed.

This guideline has been developed in accordance with the American Academy of Dermatology (AAD)/AAD Association "Administrative Regulations for Evidence-based Clinical Practice Guidelines," which include the opportunity for review and comment by the entire AAD membership and final review and approval by the AAD Board of Directors.

Level of evidence grades (I-III) and strength of recommendations (A-C) are defined at the end of the "Major Recommendations" field.

Table: Strength of Recommendations for the Treatment of Psoriasis Using Topical Therapies

Recommendations for Topical Corticosteroids

Indication: Plaque-type psoriasis

Dosing

• Can be used as monotherapy 1-2 times daily
• Can be combined with other topical agents, ultraviolet (UV) light, and systemic agents

Potency of Topical Steroids

• Stoughton-Cornell classification system divide steroids into 7 classes

Duration of Dosing

• Class I steroids: available data for 2-4 weeks of treatment
• Less potent agent: optimal end point unknown
• Gradual reduction in usage recommended following clinical response; while optimal end point is unknown, unsupervised continuous use is not recommended.
• For clobetasol and halobetasol, maximal weekly use should be 50 g or less.

Short-term Results

• Highly potent agents have greater efficacy than less potent agents.
• Vehicle, usage area, patient preference, patient age, and cost after efficacy
• See Table 1 in the original guideline document for efficacy rates.

Long-term Results

• True efficacy and risks associated with long-term use are unknown as most clinical trials are of short duration.
• Tachyphylaxis, while not demonstrated in clinical trials, may affect the long-term results achieved in a given patient.
• Combination with other topicals and variations in dosing schedules may lessen risk of long-term side effects.

Toxicities

• Local―skin atrophy, telangiectasia, striae, purpura, contact dermatitis, rosacea
• Systemic—hypothalamic-pituitary-adrenal axis suppression may occur with use of medium- and high-potency topical steroids. This will be lessened by intermittent or localized use. Unilateral or bilateral avascular necrosis of the femoral head rarely occurs. Increased intraocular pressure, glaucoma, and cataracts have been reported with use around the eye.
• Risk increase when used with excessive frequency or duration
• It is unknown if there is an increased risk of infection with long-term use.

Baseline Monitoring: None

Ongoing Monitoring

• Assessment of growth in children using topical corticosteroids for long term
• Regular skin checks for all patients receiving long-term therapy to assess for atrophy

Pregnancy: Category C

Nursing: Unknown safety

Pediatric use: Because of the increased skin surface/body mass ratio, the risks to infants and children may be higher for systemic effects secondary to enhanced absorption. Growth retardation is also a potential concern.

Recommendations for Vitamin D Analogues

Indication: Plaque-type psoriasis

Dosing: Twice daily to affected areas

Efficacy

• In two large studies of plaque-type psoriasis of the body, 70% to 74% of patients treated with calcitriol or calcipotriene ointment shower either 75% improvement or marked improvement to clearing as compared with 18% to 19% of patients treated with placebo. Sixty percent of scalp psoriasis patients treated with calcipotriene solution showed clearance or marked improvement as compared with 17% of placebo patients.
• Combination of calcipotriene and betamethasone ointment: In a 4-week trial of patients with mild to severe plaque psoriasis, 48% of patients treated with the combination agent achieved absent or mild psoriasis, compared with 16.5% of patients treatment with calcipotriene once daily, 26.3% of patients treated with betamethasone once daily, and 7.6% of patients treated with placebo. A 52-week clinical practice dosage study showed 70% to 80% of patients achieving clear or almost clear status with no drug-related serious adverse events, such as HPA axis oppression or striae when used on an as-needed basis.

Use in combination with topical corticosteroids gives added benefit.

Contraindications/Adverse Reactions

• Irritation in lesional and perilesional skin that is transient
• Reversible elevation of serum calcium-more likely to occur in patients treated with greater than 100 g/week.
• Causes photosensitivity, but no contraindications to combining with ultraviolet light B (UVB) phototherapy; when using combination calcipotriene/betamethasone, the side effects of high-potency topical corticosteroids including hypothalamic-pituitary-adrenal (HPA) axis suppression, skin atrophy, among others may occasionally occur.

Pregnancy and Nursing

• Category C
• No information on excretion in breast milk; pregnant and nursing mothers were excluded from clinical studies.

Pediatric use: Appears to be safe

Recommendations for Topical Tazarotene

Indication: Plaque-type psoriasis

Dosing: Applied once daily

Efficacy

• 50% or more improvement, seen in 63% and 50% of patients treated with tazarotene 0.1% gel and 0.05% gel, respectively, once daily for 12 weeks, compared with 31% of patients treated with vehicle; overall lesional assessment of none, minimal, or mild found in 50% to 51% of patients treated with tazarotene 0.1% cream and 0.05% cream used once daily for 12 weeks, compared with 25% of patients treated with vehicle

Best used in combination with topical corticosteroids

Contraindications/Adverse Reactions

• Most common side effect is skin irritation in lesional and perilesional skin.
• Photosensitizing

Pregnancy and Nursing

• Pregnancy category X
• Excreted in mammalian milk, but quantity in human milk is unclear

Pediatric Use: No available data in psoriasis in patients younger than 18 years of age; for acne, approved to age 12 years.

Recommendations for Topical Tacrolimus and Pimecrolimus

Indication: No U.S. Food and Drug Administration (FDA)-approved indications for psoriasis; primary indications for off-label use are for facial and intertriginous psoriasis.

Dosing: Applied twice daily to affected areas; no duration of course is specified.

Efficacy

• Plaque psoriasis: Not generally effective
• Intertriginous and facial psoriasis: 65% of patients treated with tacrolimus 0.1% ointment were clear or almost clear after 8 weeks of therapy compared with 31% of patients treated with placebo; 71% of the patients treated with pimecrolimus 0.1% cream were clear or almost clear after 8 weeks of therapy as compared with 21% of patients treated with placebo.

Contraindications/Adverse Reactions

• There are no specific contraindications/adverse reactions for psoriasis.
• Most common side effect for both medications is burning and itching.
• A controversial lymphoma "black box" warning has been issued by the Food and Drug Administration (FDA).

Pregnancy and Nursing

• Category C
• Tacrolimus and pimerrolimus are found in human milk and are not recommended for nursing mothers.

Pediatric Use: Topical tacrolimus (0.03%) and topical pimecrolimus are approved for patients 2 years of age or older for atopic dermatitis.

Recommendations for Emollients

Indication: The use of emollients represents an internationally accepted standard adjunctive therapeutic approach to the treatment of psoriasis.

Dosing: Applied once to 3 times daily

Efficacy: Two controlled studies of aloe vera had conflicting results.

Contraindications/Adverse Reactions: No known contraindications

Pregnancy and Nursing: Generally considered safe

Pediatric Use: Generally considered safe

Recommendations for Salicylic Acid

Indication: No specific FDA indication

Dosing: Applied daily

Efficacy: Data are limited on salicylic acid used alone.

• Comparator study of tacrolimus and salicylic acid versus tacrolimus alone in small study (N=24) of psoriasis patients with <10% body surface area (BSA) revealed improved efficacy with addition of salicylic acid
• Comparator study of 408 patients with moderated to severe psoriasis treated with mometasone and salicylic acid versus mometasone alone for 3 weeks; psoriasis severity index measure erythema, induration, and scaling showed the combination of mometasone furoate-salicylic acid to be more effective than mometasone furoate alone.

Contraindications/Adverse Reactions: Do not combine salicylic acid with other salicylate drugs. Systemic absorption, although rare, can occur, especially when applied to more than 20% of body surface area or in patients with abnormal hepatic or renal function. Salicylic acid decreased the efficacy of UVB phototherapy because of a filtering effect and should not be used before UVB phototherapy.

Pregnancy and Nursing: Appears to be a safe choice for the control of localized psoriasis in pregnancy

Pediatric Use: Because of greater risk of systemic absorption and toxicity, salicylic acid should be avoided in children.

Recommendations for Anthralin

Indication: Was important component of psoriasis treatment for many years

Dosing: Several doses are available; now commonly used as short-contact therapy, starting at 1% concentration with increasing concentration over time as tolerated. Efficacy: Limited placebo-controlled trial data, but as monotherapy, anthralin appears to have lower efficacy than more potent topical corticosteroids or vitamin D derivatives.

Contraindications/Adverse Reactions: Most common side effects are skin irritation and staining of the skin and other touching objects. Because of skin irritation, it is important to avoid contact with surrounding normal skin.

Pregnancy and Nursing: Category C

Pediatric Use: Use with caution

Recommendations for Coal Tar

Indication: Used in the treatment of psoriasis for more than 100 years; although the use of tar products for treatment of localized psoriasis has decreased over time in the United States, they are still often used in other counties.

Dosing: Many formulations exist.

Efficacy: In double-blind, randomized, controlled trail of 324 patients with mild to moderate psoriasis comparing 1% coal tar lotion with 5% coal tar extract, there was better improvement in both Psoriasis Area and Severity Index (PASI) and total sign score (TSS) in patients treated with 1% lotion than in 5% extract.

Contraindications/Adverse Reactions: Often poorly tolerated by patients because of cosmetic issues, including staining of clothes and tar odor; other potential adverse events include irritant contact dermatitis, folliculitis, and photosensitivity. Coal tar is carcinogenic in animals, but in humans, there are no convincing data proving carcinogenicity, and epidemiologic studies fail to show increased risk of skin cancer in patients who use coal tar.

Pregnancy and Nursing: Risk of topical coal tar used for brief periods of time during pregnancy is likely to be small.

Pediatric Use: Use with caution

Definitions:

Levels of Evidence

1. Good-quality patient-oriented evidence
2. Limited-quality patient-oriented evidence
3. Other evidence including consensus guidelines, opinion, or case studies

Strength of Recommendations

1. Recommendation based on consistent and good-quality patient-oriented evidence
2. Recommendation based on inconsistent and limited-quality patient-oriented evidence
3. Recommendation based on consensus, opinion, or case studies

None provided

The type of supporting evidence is identified and graded for selected recommendations (see "Major Recommendations").

Appropriate management and treatment of psoriasis and psoriatic arthritis

Adverse Effects of Treatment

• Compatibility issues with use of multiple topical agents
• Topical corticosteroids: Local side effects--skin atrophy, telangiectasia, striae, purpura, contact dermatitis, rosacea. Systemic side effects--hypothalamic-pituitary-adrenal axis suppression may occur with the use of medium-and high-potency topical steroids. Unilateral or bilateral avascular necrosis of the femoral head rarely occurs. Increased intraocular pressure, glaucoma, cataracts have been reported with use around the eye. Risks increase when used with excessive frequency or duration. It is unknown if there is an increased. It is unknown if there is an increased risk of infection with long-term use. Because of the increased skin surface/body mass ration, the risks to infants and children may be higher for systemic effects secondary to enhanced absorption. Growth retardation is also a potential concern.
• Vitamin D analogues: Irritation in lesional and perilesional skin that is transient; reversible elevation of serum calcium; causes photosensitivity.
• Tazarotene: Most common side effect is skin irritation in lesional and perilesional skin; photosensitizing.
• Tacrolimus and pimecrolimus: Most common side effect for both medications is burning and itching. Lymphoma "black box" warning issued by the Food and Drug Administration (FDA).
• Salicylic acid: Systemic absorption, though rare, can occur.
• Anthralin: Most common side effects are skin irritation and staining of the skin and other touching objects.
• Coal tar: Often poorly tolerated because of cosmetic issues, such as staining of clothes and tar odor; other potential adverse events include irritant contact dermatitis, folliculitis, and photosensitivity. Coal tar is carcinogenic in animals, but in humans, there are no convincing data proving carcinogenicity.

Adherence to these guidelines will not ensure successful treatment in every situation. Furthermore, these guidelines should not be deemed inclusive of all proper methods of care nor exclusive of other methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specific therapy must be made by the physician and the patient in light of all the circumstances presented by the individual patient.

An implementation strategy was not provided.

Not applicable: The guideline was not adapted from another source.

American Academy of Dermatology operational funds and member volunteer time supported the development of this guideline.

American Academy of Dermatology Work Group

Work Group Members: Alan Menter, MD, Chair, Baylor University Medical Center, Dallas; Neil J. Korman, MD, PhD, Department of Dermatology, Murdough Family Center for Psoriasis, Department of Dermatology, University Hospitals Case Medical Center, Cleveland; Craig A. Elmets, MD, Department of Dermatology, University of Alabama at Birmingham; Steven R. Feldman, MD, PhD, Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem; Joel M. Gelfand, MD, MSCE, Department of Dermatology and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia; Kenneth B. Gordon, MD, Division of Dermatology, Evanston Northwestern Healthcare and Department of Dermatology, Northwestern University, Fienberg School of Medicine, Chicago; Alice Gottlieb, MD, PhD, Tufts Medical Center, Tufts University School of Medicine, Boston; John Y. M. Koo, MD, Department of Dermatology, University of California - San Francisco; Mark Lebwohl, MD, Department of Dermatology, Mount Sinai School of Medicine, New York; Henry W. Lim, MD, Department of Dermatology, Henry Ford Hospital, Detroit; Abby S. Van Voorhees, MD, Department of Dermatology, University of Pennsylvania, Philadelphia; Karl R. Beutner, MD, PhD, Department of Dermatology, University of California, San Francisco, Anacor Pharmaceuticals Inc, Palo Alto; Reva Bhushan, PhD, American Academy of Dermatology

Alan Menter, MD: Dr Menter served on the Advisory Board and was a consultant, investigator, and speaker for Abbott Labs, Amgen, and Centocor, receiving grants and honoraria; served on the Advisory Board and was an investigator and consultant for UCB Pharma, receiving grants and honoraria; was a consultant, investigator and speaker for Warner Chilcott and Wyeth, receiving honoraria; served on the Advisory Board and was an investigator for Galderma and Genentech, receiving grants and honoraria; was a consultant and investigator for Astellas, receiving grants and honoraria; was an investigator for 3M Pharmaceuticals and XOMA, receiving grants and Novo Nordisk, receiving no compensation.

Neil J. Korman, MD, PhD: Dr Korman has served on the Advisory Board and was investigator and speaker for Genentech and Astellas Pharma Inc, receiving grants and honoraria; served on the Advisory Board and was investigator for Centocor, receiving grants and residency/fellowship program funding; was investigator and speaker for Amgen, receiving grants and honoraria; and served on the Advisory Board, was consultant, investigator, and speaker for Abbott Labs, receiving grants and honoraria.

Craig A. Elmets, MD: Dr Elmets has served on the Advisory Board and was investigator for Amgen and Abbott Labs, receiving grants and honoraria; was consultant for Astellas Pharma Inc, receiving honoraria; and was an investigator for Genentech, Centocor, and Connetics, receiving grants.

Steven R. Feldman, MD, PhD: Dr Feldman served on the Advisory Board and was investigator and speaker for Galderma, Stiefel Laboratories, Warner Chilcott, Abbott Labs, and Astellas Pharma Inc, receiving grants and honoraria; served on the Advisory Board for PhotoMedex, receiving stock options; received grants from National Psoriasis Foundation and Dermatology Foundation, CORIA Laboratories, Ltd, Aventis Pharma, American Society of Dermatologic Surgery, Ortho Pharma, and Roche Dermatology; was an investigator and speaker for Amgen, Centocor, and Genentech, receiving grants and honoraria; was a speaker and consultant for Bristol-Myers Squibb Derm and Biogen Idec, receiving grants; and speaker for 3M and Novartis, receiving grants.

Joel M. Gelfand, MD: Dr Gelfand served as consultant and investigator with Amgen, Centocor, Abbott Labs, and Pfizer, receiving grants and honoraria; was consultant with Wyeth, Genentech, Shire Pharmaceuticals, Covance, Celgene, and Luitpold Pharmaceuticals, receiving honoraria; and investigator with Shionogi, receiving grants.

Kenneth B. Gordon, MD: Dr Gordon served on the Advisory Board and was consultant, investigator, and speaker for Abbott Labs and Amgen, receiving grants and honoraria; was investigator for Genentech, receiving grants; and was on the Advisory Board, a consultant and investigator for Centocor, receiving grants and honoraria.

Alice Gottlieb, MD, PhD: Dr Gottlieb served as a speaker, consultant, and was on the Advisory Board for Amgen Inc and Wyeth Pharmaceuticals; has consulting/ advisory board agreements with Beiersdorf, Abbott Labs, Sankyo, Kemia, Actelion, Novo Nordisk, Immune Control, Dermipsor, Can-Fite, Celgene, Centocor, Inc, Bristol-Myers Squibb, Warner Chilcott, Roche, Medarex, Celera, UCB, Almirall, RxClinical, MEDACorp, and Incyte; and has consulted for Magen BioSciences, PureTech, and Teva. She has received grants from Amgen, Wyeth Pharmaceuticals, Immune Control, Celgene, Centocor, Inc, Incyte, and PharmaCare. Almost all income has been paid to her employer directly.

John Y. M. Koo, MD: Dr Koo served on the Advisory Board, was speaker, consultant, and investigator for Amgen, Abbott Labs, Astellas, Warner Chilcott, and Galderma, receiving grants and honoraria; was investigator for Genentech, receiving grants; and was on the Advisory Board, consultant and investigator for Photomedix and Teikoku, receiving no compensation.

Mark Lebwohl, MD: Dr Lebwohl served on the Advisory Board and was speaker for Abbott Labs, Amgen, Astellas, Centocor, Galderma, Genentech, Stiefel, and Warner Chilcott, receiving honoraria; served on the Advisory Board and was consultant and speaker for PharmaDerm, receiving honoraria; was speaker for Novartis and Ranbaxy Laboratories, receiving honoraria; was consultant for Biogen, UCB, DermiPsor, Isotechnika, Sanofi-Aventis, Triax, and York Pharma receiving honoraria; and was on the Advisory Board for Medicis and Pfizer, receiving honoraria Members of Dr Lebwohl's department own patents on short-contact tazarotene, topical genistein, and use of the excimer laser for vitiligo.

Henry W. Lim, MD: Dr Lim is an investigator for Orfagen, receiving grants; a consultant with LaRoche- Posay receiving honoraria; and consultant and investigator with Johnson & Johnson, receiving grants and honoraria. As chairman, Dr. Lim's department's clinical research office participates in many clinical trials, none of which benefit him directly.

Abby S. Van Voorhees, MD: Dr Van Voorhees served on the Advisory Board, was an investigator and speaker for Amgen and Genentech, receiving grants and honoraria; investigator for Astellas, IDEC, and Roche, receiving grants; on the Advisory Board and investigator for Bristol- Myers Squibb and Warner Chilcott, receiving grants and honoraria; on the Advisory Board and speaker for Abbott Labs, Centocor, and Connetics, receiving honoraria; was consultant for Incyte, Xtrac, and VGX Pharmaceuticals, receiving honoraria, and has received honoraria from Synta Pharmaceuticals for another function. Dr Van Voorhees' spouse is an employee with Merck, receiving a salary, stock, and stock options.

Karl R. Beutner, MD, PhD: Chair, Clinical Research Committee. Dr Beutner was an employee of Anacor, receiving salary, stock, and stock options; stockholder of Dow Pharmaceutical Sciences receiving stock.

Reva Bhushan, PhD: Dr Bhushan had no relevant conflicts of interest to disclose.

This is the current release of the guideline.

Electronic copies: Available in Portable Document Format (PDF) from American Academy of Dermatology Association Web site .

Print copies: Available from the AAD, PO Box 4014, Schaumburg, IL 60168-4014, Phone: (847) 330-0230 ext. 333; Fax: (847) 330-1120; Web site: www.aad.org .

American Academy of Dermatology guidelines are available in a mobile-friendly format from the American Academy of Dermatology Web site .

None available

This NGC summary was completed by ECRI Institute on September 15, 2009. The information was verified by the guideline developer on October 20, 2009.

The American Academy of Dermatology Association places no restriction on the downloading, use, or reproduction of its guidelines.