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Brief Summary

GUIDELINE TITLE

Guidelines of care for acne vulgaris management.

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

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

  1. Systems for the Grading and Classification of Acne
    • Clinicians may find it helpful to use a consistent classification/grading scale (encompassing the numbers and types of acne lesions as well as disease severity) to facilitate therapeutic decisions and assess response to treatment.
Recommendation Strength of Recommendation Level of Evidence References
Grading/classification system B II Lehmann et al., 2002; Pochi et al., 1991; Doshi, Zaheer, & Stiller, 1997; Allen & Smith, 1982; Cook, Centner, & Michaels, 1979; Lewis-Jones & Finlay, 1995
  1. Microbiologic and Endocrinologic Testing

    Microbiologic Testing

    • Routine microbiologic testing is unnecessary in the evaluation and management of patients with acne.
    • Those who exhibit acne-like lesions suggestive of gram-negative folliculitis may benefit from microbiologic testing.
    Recommendation Strength of Recommendation Level of Evidence References
    Microbiologic testing B II Cove, Cunliffe, & Holland, 1980; Bojar et al., 1995; Eady et al., 1989; Harkaway et al., 1992

    Endocrinologic Testing

    • Routine endocrinologic evaluation (e.g., for androgen excess) is not indicated for the majority of patients with acne. Laboratory evaluation is indicated for patients who have acne and additional signs of androgen excess. In young children this may be manifested by body odor, axillary or pubic hair, and clitoromegaly. Adult women with symptoms of hyperandrogenism may present with recalcitrant or late-onset acne, infrequent menses, hirsutism, male or female pattern alopecia, infertility, acanthosis nigricans, and truncal obesity.
    Recommendation Strength of Recommendation Level of Evidence References
    Endocrinologic testing A I Lawrence et al., 1981; Lucky et al., "Predictors," 1997
  1. Topical Therapy
    • Topical therapy is a standard of care in acne treatment.
    • Topical retinoids are important in acne treatment.
    • Benzoyl peroxide and combinations with erythromycin or clindamycin are effective acne treatments.
    • Topical antibiotics (e.g., erythromycin and clindamycin) are effective acne treatments. However, the use of these agents alone can be associated with the development of bacterial resistance.
    • Salicylic acid is moderately effective in the treatment of acne.
    • Azelaic acid has been shown to be effective in clinical trials, but its clinical use, compared to other agents, has limited efficacy according to experts.
    • Data from peer-reviewed literature regarding the efficacy of sulfur, resorcinol, sodium sulfacetamide, aluminum chloride, and zinc are limited.
    • Employing multiple topical agents that affect different aspects of acne pathogenesis can be useful. However, it is the opinion of the work group that such agents not be applied simultaneously unless they are known to be compatible.
Recommendation Strength of Recommendation Level of Evidence References
Retinoids A I Christiansen et al., 1974, Chalker et al., 1987; Shalita et al., 1999; Lucky et al., 1998
Benzoyl peroxide A I Belknap, 1979; Schutte, Cunliffe, & Forster, 1982; Smith et al., 1980; Mills et al., 1986
Antibiotics A I Bernstein & Shalita, 1980; Jones & Crumley, 1981; Prince et al., 1981; Lesher et al., 1985; Pochi et al., 1988; Dobson & Belknap, 1980; Mills et al., 2002; Leyden et al., 1987; Becker et al., 1981
Other agents A I Zouboulis et al., 2000; Chalker et al., 1983; Tschen et al., 2001; Lookingbill et al., 1997; Hjorth & Graupe, 1989
  1. Systemic Antibiotics
    • Systemic antibiotics are a standard of care in the management of moderate and severe acne and treatment-resistant forms of inflammatory acne.
    • Doxycycline and minocycline are more effective than tetracycline, and there is evidence that minocycline is superior to doxycycline in reducing Propionibacterium acnes.
    • Although erythromycin is effective, use should be limited to those who cannot use the tetracyclines (i.e., pregnant women or children under 8 years of age because of the potential for damage to the skeleton or teeth). The development of bacterial resistance is also common during erythromycin therapy.
    • Trimethoprim-sulfamethoxazole and trimethoprim alone are also effective in instances where other antibiotics cannot be used.
    • Bacterial resistance to antibiotics is an increasing problem.
    • The incidence of significant adverse effects with antibiotic use is low. However, adverse effect profiles may be helpful for each systemic antibiotic used in the treatment of acne.
Recommendation Strength of Recommendation Level of Evidence References
Tetracyclines A I Smith, Chalker, & Wehr, 1976; Gratton et al., 1982; Blaney & Cook, 1976; Miller et al., 1996
Macrolides A I Skidmore et al., 2003; Gammon et al., 1986; Christian & Krueger, 1975; Stoughton et al., 1980
Trimethoprim-sulfamethoxazole A I Hersle, 1972
  1. Hormonal Agents
    • Estrogen-containing oral contraceptives can be useful in the treatment of acne in some women.
    • Oral antiandrogens, such as spironolactone and cyproterone acetate, can be useful in the treatment of acne. While flutamide can be effective, hepatic toxicity limits its use. There is no evidence to support the use of finasteride.
    • There are limited data to support the effectiveness of oral corticosteroids in the treatment of acne. There is a consensus of expert opinion that oral corticosteroid therapy is of temporary benefit in patients who have severe inflammatory acne.
    • In patients who have well-documented adrenal hyperandrogenism, low-dose oral corticosteroids may be useful in treatment of acne.
Recommendation Strength of Recommendation Level of Evidence References
Contraceptive agents A I Lucky et al., "Effectiveness," 1997; Olson, Lippman, & Robisch, 1998; Thiboutot et al., 2001; Leyden et al., 2002
Spironolactone B II Muhlemann et al., 1986
Antiandrogens B II Greenwood et al., 1985; Miller et al., 1986
Oral corticosteroids B II Nader et al., 1984
  1. Isotretinoin
    • Oral isotretinoin is approved for the treatment of severe recalcitrant nodular acne.
    • It is the unanimous opinion of the acne work-group that oral isotretinoin is also useful for the management of lesser degrees of acne that are treatment-resistant or for the management of acne that is producing either physical or psychological scarring.
    • Oral isotretinoin is a potent teratogen. Because of its teratogenicity and the potential for many other adverse effects, this drug should be prescribed only by those physicians knowledgeable in its appropriate administration and monitoring.
    • Female patients of child-bearing potential must only be treated with oral isotretinoin if they are participating in the approved pregnancy prevention and management program (iPLEDGE*).
    • Mood disorders, depression, suicidal ideation, and suicides have been reported in patients taking this drug. However, a causal relationship has not been established.

    *Because of the teratogenic effects of isotretinoin on the fetus, the FDA and the manufacturers have approved a new risk management program for isotretinoin. Prescribers, patients, pharmacies, drug wholesalers, and manufacturers in the United States are required to register and comply with the iPLEDGE program. This program requires mandatory registration of all patients receiving this drug. Detailed information can be found on the iPLEDGE web site (www.ipledgeprogram.com).

Recommendation Strength of Recommendation Level of Evidence References
Isotretinoin A I Peck et al., 1982; Lehucher-Ceyrac & Weber-Buisset, 1993; Goulden et al., 1997; Strauss et al., "A randomized trial," 2001; McElwee et al., 1991; Strauss et al., "Safety," 2001; Dai, LaBraico, & Stern, 1992; Goldsmith et al., 2004; Rubinow et al., 1987
  1. Miscellaneous Therapy
    • Intralesional corticosteroid injections are effective in the treatment of individual acne nodules.
    • There is limited evidence regarding the benefit of physical modalities including glycolic acid peels and salicylic acid peels.
Recommendation Strength of Recommendation Level of Evidence References
Intralesional steroids C III Levine & Rasmussen, 1983; Potter, 1971
Chemical peels C III Kim et al., 1999; Wang et al., 1997; Grimes, 1999
Comedo removal C III Pepall, Cosgrove, & Cunliffe, 1991
  1. Complementary Therapy
    • Herbal and alternative therapies have been used to treat acne. Although these products appear to be well tolerated, very limited data exist regarding the safety and efficacy of these agents.
Recommendation Strength of Recommendation Level of Evidence References
Herbal agents B II Bassett, Pannowitz, & Barnetson, 1990; Paranjpe & Kulkarni, 1995; Lalla et al., 2001
Psychological approaches C III Ellerbroek, 1973
Hypnosis/biofeedback B II Hughes et al., 1983
  1. Dietary Restriction
    • Dietary restriction (either specific foods or food classes) has not been demonstrated to be of benefit in the treatment of acne.
Recommendation Strength of Recommendation Level of Evidence References
Effect of diet B II Bett, Morland, & Yudkin, 1967; Fulton, Plewig, & Kligman, 1969

Definitions:

Levels of Evidence

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

Strength of Recommendations

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

CLINICAL ALGORITHM(S)

None provided

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EVIDENCE SUPPORTING THE RECOMMENDATIONS

REFERENCES SUPPORTING THE RECOMMENDATIONS

References open in a new window

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

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

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IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

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

DATE RELEASED

2007 Apr

GUIDELINE DEVELOPER(S)

American Academy of Dermatology - Medical Specialty Society

SOURCE(S) OF FUNDING

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

GUIDELINE COMMITTEE

American Academy of Dermatology Work Group
American Academy of Dermatology Clinical Guidelines Task Force

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Work Group Members: John S. Strauss, MD, Chair, Department of Dermatology, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City; Daniel P. Krowchuk, MD, Departments of Pediatrics and Dermatology, Wake Forest University School of Medicine, Brenner Children's Hospital, Winston-Salem; James J. Leyden, MD, Department of Dermatology, University of Pennsylvania Hospital, Philadelphia; Anne W. Lucky, MD, Division of Pediatric Dermatology, Cincinnati Children's Hospital Medical Center and University of Cincinnati School of Medicine, Cincinnati; Alan R. Shalita, MD, Department of Dermatology, State University of New York Downstate Medical Center, Brooklyn; Elaine C. Siegfried, MD, Department of Dermatology, St Louis University School of Medicine, St Louis; Diane M. Thiboutot, MD, Department of Dermatology, Pennsylvania State University College of Medicine, Milton S. Hershey Medical Center, Hershey; Abby S. Van Voorhees, MD, Department of Dermatology, University of Pennsylvania Hospital, Philadelphia; Karl A. Beutner, MD, PhD, Anacor Pharmaceuticals, Inc, Palo Alto; Carol K. Sieck, RN, MSN, American Academy of Dermatology, Schaumburg; Reva Bhushan, PhD, American Academy of Dermatology, Schaumburg

Task Force Members: Karl A. Beutner, MD, PhD, Chair; Mark A. Bechtel, MD; Michael E. Bigby, MD; Craig A. Elmets, MD; Steven R. Feldman, MD, PhD; Joel M. Gelfand, MD; Brad P. Glick, DO, MPH; Cindy F. Hoffman, DO; Judy Y. Hu, MD; Jacqueline M. Junkins-Hopkins, MD; Jeannine L. Koay, MD; Gary D. Monheit, MD; Abrar A. Qureshi, MD, MPH; Ben M. Treen, MD; Carol K. Sieck, RN, MSN

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Each of the following Work Group Members have served as a consultant, received research support or clinical research grants from the following companies:

Dr. Strauss was a consultant and investigator for Roche Laboratories receiving honoraria and grants, and a consultant for Medicis receiving honoraria.

Dr. Krowchuk has no relevant conflicts of interest to disclose.

Dr. Leyden was a consultant for Stiefel and SkinMedica, receiving honoraria; served on the Advisory Board and was a consultant for Galderma and Obaj, receiving honoraria; was on the Advisory Board and was a consultant and investigator for Connetics, Collagenex, Allergan, and Medicis, receiving honoraria.

Dr. Lucky was an investigator for Connetics, Dow, Galderma, Healthpoint, Johnson & Johnson, QLT, and Stiefel, receiving grants and an investigator and consultant for Berlex receiving grants and honoraria.

Dr. Shalita was a consultant, investigator, stockholder, and speaker for Allergan, receiving grants and honoraria; a consultant for Bradley/Doak receiving honoraria; served on the Advisory Board and was a consultant for Collagenex, receiving honoraria; was a consultant and investigator for Connetics receiving grants and honoraria; an Advisory Board member, consultant, investigator, and speaker for Galderma receiving grants and honoraria; a consultant, speaker, and stockholder for Medicis receiving honoraria; an Advisory Board member for Ranbaxy receiving honoraria; and a consultant, investigator, and speaker for Stiefel, receiving grants and honoraria.

Dr. Siegfried was an investigator for Atrix receiving salary.

Dr. Thiboutot served on the Advisory Board and was an investigator and speaker for Allergan and Galderma, receiving honoraria; was on the Advisory Board and was a consultant and investigator for Collagenex receiving honoraria; was on the Advisory Board and was an investigator for Connetics, Dermik, and QLT, receiving honoraria; and was a consultant, investigator, and speaker for Intendis, receiving honoraria.

Dr. Van Voorhees served on the Advisory Board and was an investigator and speaker for Amgen, receiving grants and honoraria; was an investigator for Astellas, Bristol Myers Squibb, and GlaxoSmithKline, receiving grants; was an Advisory Board Member and investigator for Genentech and Warner Chilcott, receiving grants and honoraria; was on the Advisory Board for Centocor receiving honoraria; was a speaker for Connetics receiving honoraria; and was a stockholder of Merck, owning stock and stock options.

Dr. Beutner was an employee of Anacor receiving salary and stock options and a stockholder of Dow Pharmaceutical Sciences receiving stock.

Ms. Sieck and Dr. Bhushan have no relevant conflicts of interest to disclose.

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

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.

AVAILABILITY OF COMPANION DOCUMENTS

The following is available:

  • Guidelines of care for acne vulgaris management. Technical report. American Academy of Dermatology Association. 2007. 69 p.

Electronic copies: Not available at this time.

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.

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI Institute on July 25, 2007. The information was verified by the guideline developer on August 2, 2007.

COPYRIGHT STATEMENT

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

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Readers with questions regarding guideline content are directed to contact the guideline developer.
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