Fitzpatrick Skin Types and Clindamycin Phosphate 1.2%/Benzoyl Peroxide Gel: Efficacy and Tolerability of Treatment in Moderate to Severe Acne
May 2012 | Volume 11 | Issue 5 | Original Article | 643 | Copyright © May 2012
Background: Acne in skin of color is an increasing problem, presenting unique challenges. Although combination therapy is now standard of care in acne, concerns exist with the increased potential irritation and dryness in skin of color. Although individual medications
can be titrated or applied at different times of the day to minimize irritation, this is not always practical or desirable. There is a paucity of
clinical studies that evaluate the safety and efficacy of acne medications in skin of color.
Methods: A post-hoc analysis of efficacy and cutaneous tolerability in 797 subjects receiving clindamycin phosphate 1.2% benzoyl peroxide (BPO) 2.5% gel from two 12-week, multi-center, double-blind studies that enrolled 2,813 subjects with moderate to severe acne. Efficacy, tolerability, and subject satisfaction in Fitzpatrick skin types I-III subjects were compared to subjects with Fitzpatrick skin types IV-VI.
Results: Median reductions in inflammatory lesions were comparable between the two groups. There was a small difference in non -
inflammatory and total lesions in favor of those patients with Fitzpatrick skin types I-III (P=0.013 and P=0.024, respectively). Median
reductions in inflammatory, noninflammatory, and total lesions at week 12 were 63%, 50%, and 52.4%, respectively for Fitzpatrick
skin types I-III and 65%, 47%, and 51.4%, respectively for Fitzpatrick skin types IV-VI. Treatment success was comparable between
the two groups and both groups had a high level of subject satisfaction at week 12. Cutaneous tolerability was excellent, with all mean
scores less than or equal to 0.2 at week 12 (where 1=mild). Results in the two groups were comparable, although there was slightly
more erythema reported in the Fitzpatrick skin types I-III subjects (0.2 versus 0.1). This could be due to the difficulty in vis ualizing erythema in subjects with darker skin.
Conclusions: Acne subjects with Fitzpatrick skin types IV-VI were not found to be more susceptible to cutaneous irritation from treatment
with clindamycin phosphate 1.2%/BPO 2.5% gel and both efficacy and tolerability was comparable across the two treatment groups.
J Drugs Dermatol. 2012;11(5):643-648.
People of color represent the fastest-growing segment of
the US population. In 2000, they represented less than
one-third of the nation's total population. By 2050, U.S.
Census estimates suggest that this diverse cross-section of ethnicities—Hispanics, African-Americans, Asians, and other non-
Caucasians—will account for half of the population.1
Affecting about 40 to 50 million Americans,2 acne is one of the
most common skin diagnoses in both the general population and
skin of color (defined clinically as Fitzpatrick skin types IV-VI).3 It
has been identified as the most common skin problem in African-Americans and Hispanics and the second most common in
Asians. Studies have reported an overall prevalence as high as
29% in African-American patients.4
Among people of color, severity of acne, its sequelae, and approach to treatment can all vary from patients with lighter skin
types.5 For example, papules are the most frequent presentation of acne in skin of color, occurring in over 70% of patients with comedonal lesions occurring in 46% of African-Americans.6,7 These
comedonal lesions display a substantial amount of inflammation.
Indeed, marked inflammation has been shown in all types of lesions through histological examination of biopsy samples that
was not consistent to what was seen clinically. The heightened inflammatory response in these African-Americans may account for
the greater levels of postinflammatory hyperpigmentation (PIH)
reported in this group, even in mild-to-moderate acne.8
Postinflammatory hyperpigmentation can be triggered in darker-skinned patients by skin irritation independent of cause and can
be equally or more concerning.9-12 For example, hyperpigmentation can occur as a result of benzoyl peroxide (BPO) use if the
patient develops irritationa concentration-dependent sensitivity
occurring in up to 5% of the population13 . As a result, lower concentrations of BPO (2.5%) should be used to evaluate potential
irritation and PIH.14 Studies have documented that the use of retinoids in skin of color, in addition to effectively treating non-
inflammatory and inflammatory acne, may also improve PIH.15 However, some physicians have concerns with using retinoids
in skin of color due to their potential to induce an irritant contact dermatitis, which could lead to PIH.16 Retinoid use has been
limited in skin of color by some physicians because of concerns
about irritation, which could lead to PIH.16