Ciclopirox Shampoo for Treating Seborrheic Dermatitis

A. K. Gupta MD, PhD, FRCPC; R. Bluhm BSc (Hons), BA, MA


Skin Therapy Letter. 2004;9(6) 

In This Article

Treating Seborrheic Dermatitis

The two main classes of treatment for seborrheic dermatitis are topical corticosteroids and antifungal agents. Corticosteroids reduce inflammation, thus resulting in clinical improvement of seborrheic dermatitis. However, prolonged treatment with topical steroids may result in adverse effects on the skin, such as atrophy, telangiectasia, or perioral dermatitis[14] and, especially in the case of higher potency, fluorinated topical steroids, to dysfunction of the adrenal cortex.[15] Because of the adverse effects associated with topical steroids, there has been a shift in treatment strategies for seborrheic dermatitis with an increased interest in antifungal agents. Several antifungal agents have been found to be effective in the treatment of seborrheic dermatitis. These include non-specific agents (e.g., zinc pyrithione, selenium sulfide, propylene glycol, lithium succinate), hydroxypyridones (e.g., ciclopirox), azoles (e.g., bifonazole, fluconazole, itraconazole, ketoconazole, miconazole, metronidazole), and the allylamines (e.g., terbinafine).

Ciclopirox is the ethanolamine salt of 6-cyclohexyl-I-hydroxy-4-methyl-2(IH)-pyridone.[16] The empirical formula of ciclopirox is C12H17NO2, with a molecular weight of 207.27.17 Ciclopirox shampoo 1% is a colorless, translucent solution,[17] which has been used in the treatment of seborrheic dermatitis.

In addition to its effect on Malassezia yeasts, ciclopirox has been shown to decrease inflammation. Rosen et al.[18] found that the anti-inflammatory activity of ciclopirox was greater than that of several azole agents or hydrocortisone. Ciclopirox appears to exert its anti-inflammatory effect via several pathways, including the inhibition of 5-lipoxygenase and cyclo-oxygenase.[19,20]

Clinical Trials of Ciclopirox. Vardy et al.[21] conducted a double-blind, randomized, placebo-controlled clinical study of ciclopirox olamine 1% shampoo to determine its effectiveness in the treatment of scalp seborrheic dermatitis. One hundred and two patients were randomly selected to apply either ciclopirox olamine 1% shampoo or the vehicle shampoo to the scalp for 5 minutes, twice per week for 4 weeks. Signs and symptoms of erythema, scaling, and pruritus were assessed at the end of the study, which revealed that 93% of the ciclopirox shampoo-treated patients had significantly improved or cleared compared to 41% in the placebo group (P<0.00001).

Another double-blind, randomized, vehicle-controlled study was conducted to assess the efficacy of 1% ciclopirox shampoo in the treatment of seborrheic dermatitis of the scalp.[22] Subjects were randomly selected to 5ml (10ml for shoulder-length hair or longer) of either 1% ciclopirox or vehicle shampoo twice per week for 4 weeks. Grading of erythema, scaling, and the overall status of seborrheic dermatitis was performed at week 4, using a 6-point rating scale (0=none, 1=slight, 2=mild, 3=moderate, 4=pronounced, and 5=severe). Effective treatment was defined as a score of 0 (or 1 if baseline score was ≥3) for the combined rating of global status, erythema, and scaling. It was reported that 26% of the ciclopirox-treated patients were effectively treated compared to 13% of the vehicle group (P=0.0001).[22]

Ciclopirox shampoo 1% was used twice a week in 626 patients.[17] Increased itching was the most frequent adverse event found in 1% of the subject population. Furthermore, application reactions, such as burning, erythema, and itching also occurred in 1% of the subjects.[17]

After wetting hair, apply approximately 1 teaspoon (5ml) of ciclopirox shampoo 1% to the scalp.[17] If the patient has long hair, it is recommended to use up to 2 teaspoons (10ml). Lather and leave on for 3 minutes before rinsing. Treatment should be repeated twice per week for 4 weeks, with a minimum of 3 days between each application.[17]

Evidence suggests that an abnormal or inflammatory immune system reaction to Malassezia yeasts may be the cause of seborrheic dermatitis. An available treatment for this disease is ciclopirox shampoo, which is an antifungal agent that also has antibacterial and anti-inflammatory properties. The proven efficacy and safety of ciclopirox shampoo in the treatment of seborrheic dermatitis of the scalp makes it an important addition to the treatment options available.