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NEA Approved Features

Update on the Latest Eczema Treatments

February 2016

winter conference
The recent Winter Clinical Dermatology Conference-Hawaii provided dermatologists with posters on the latest research and treatment options related to the field of dermatology. This section features those related to eczema and atopic dermatitis. 

Dupilumab Safe and Effective for AD

eczema

New data demonstrated that the novel biologic agent dupliumab significantly improved clinical outcomes compared with placebo for adults with moderate to severe atopic dermatitis (AD). Dupliumab is an investigational fully human monoclonal antibody that blocks interleukin (IL)-4 and IL-13 signaling.

For the study, Papp et al evaluated the efficacy of dupliumab 300 mg weekly using pooled data from 2 trials. The study enrolled 233 individuals in a 12- or 16-week randomized, double-blind, placebo-controlled, phase 2 study; individuals received weekly subcutaneous placebo (n=115) or dupilumab (n=118). Efficacy outcomes included absolute and percent change in Eczema Area and Severity Index (EASI) and SCORing of Atopic Dermatitis (SCORAD); participants who achieved EASI improvement ≥50 (ESAI 50) and ≥75 (EASI 75); and participants who achieved Investigator’s Global Assessment (IGA) score of ≤1 (clear or almost clear). Pooled efficacy and safety were assessed through week 12. 

At week 12, individuals in dupilumab treatment group showed significant improvement in all efficacy endpoints vs placebo. Dupilumab resulted in EASI change (mean ± standard deviation) of −21.1±12.0 from baseline values (29.3±12.4) compared with placebo (−6.9±14.0 from baseline of 31.9±13.7; P<.0001); mean percent change from baseline was greater with dupilumab vs placebo (−73.9% vs −22.9%, respectively; P<.0001). Significantly higher proportions of individuals in the dupilumab arm compared with placebo arm achieved EASI 50 and EASI 75 (85.6% and 61.0% vs 32.2% and 13.9%, respectively), and IGA ≤1 (36.4% vs 3.5%, respectively; P<.0001). Change in SCORAD from baseline was −37.0±18.8 and −10.9±19.6 for dupilumab and placebo, respectively; percent change was −56.6% vs −15.7%, respectively. 

The safety profile was acceptable and consistent with previous studies, according to the investigators. The pooled incidence of adverse events (AEs) through week 12 was similar for dupilumab (81.4%) and placebo (80.9%) treatment arms. The 3 most common AEs observed in the dupilumab group were nasopharyngitis (32.2%), headache (14.4%), and conjunctivitis (9.3%).

CeraVe Ointment Is Well Tolerated

A study from Zeichner et al evaluated the irritation, sensitization, and comeodogenic potential of CeraVe Healing Ointment in 3 study cohorts ranging in age from 18 to 79 years; skin reactions were assessed according to a 4-point scale (0=none to 4=severe).

Study cohort 1 included 108 individuals who were enrolled in an initial induction phase. The ointment was placed on the skin of the back under occlusive patch then removed after 24 hours on 3 separate days for 3 weeks. After a 2-week rest period, the ointment was applied to an untreated skin site on the back postpatch. The patch was removed 24 hours later and the skin was evaluated immediately and 72 hours after the patch was removed. Study cohort 2 included 29 participants who were evaluated over a 14-day period. The ointment or a control (water) were placed on the skin of the back under an occlusive patch, removed after 24 hours, and a fresh patch applied daily for 14 days. Study cohort 3 included 17 individuals with active case or a history of acne. CeraVe ointment, acetylated lanolin, or blank patch were applied to the skin of the back under an occlusive patch and removed after 48 to 72 hours, applications were repeated 3 times a week for 4 weeks. Additionally, follicular biopsies were performed and the presence of microcomedones were microscopically evaluated and rated on a 4-point scale (0=none to 3=severe).

Study cohort 1 showed that irritation scores were zero for both induction and challenge phases. There was no skin reactivity observed at any time. Study cohort 2 demonstrated that the total and mean cumulative irritation scores were zero for the ointment and control. Study cohort 3 had no skin irritation during the course of the study. Mean follicular scores for the ointment was 0.1 compared with 0.18 and 0.59 for the acetylated lanolin or blank patch, respectively.

Article continues on page 2

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CeraVe Ointment Improves Skin Hydration         

Another study by Zeichner et al evaluated the effect of CeraVe Healing Ointment on stratum corneum hydration and skin barrier function in both normal and barrier-compromised skin in 2 study cohorts aged 18 to 55 years.

Study cohort 1 included 16 women who had the ointment applied to the volar forearm skin and compared with a nontreated control. Skin conductance and transepidermal water loss (TEWL) measurements were taken at 2, 4, 8, and 24 hours after application. Study cohort 2 included 39 participants with Fitzpatrick skin types I-III. A controlled shave procedure was performed to create a model of impaired skin barrier function similar to that of atopic skin. The ointment was applied twice daily for 3 days and participants were compared to shaved, untreated controls. Conductance readings were measured at baseline, the day after shaving but prior to treatment, and at 4 hours, and then daily on days 2 to 4 (18 hours after application). 

Participants in Study 1 showed significant differences in both skin surface hydration and TEWL values at 2, 4, and 8 hours posttreatment in the treated skin vs untreated controls. The mean conductance readings ranged from 429.6 to 493.5 compared with 248.5 to 283.5 in untreated controls. The mean TEWL rates ranged from 2.3 to 2.6 g/m2 hour compared with 3.4 to 3.5 g/m2 hour in the untreated controls. At 24 hours, the mean conductance readings were greater than untreated controls (320.1 vs 250.3, respectively), while TEWL values returned to baseline levels.

For study cohort 2, conductance readings dropped 28% to 29% immediately postshaving, consistent with the changes associated with barrier damage. Four hours posttreatment with the ointment, skin conductance levels had returned to pretrauma values and were significantly higher than untreated shaved control (P<.001). With continued applications of the ointment, skin conductance levels increased progressively and remained statistically higher vs the untreated controls (P<.001) for the study duration.

Crisaborole Potential New Treatment for AD

Crisaborole topical ointment, 2%—an investigational, nonsteroidal, topical, anti-inflammatory, phosphodiesterase 4 inhibitor—may offer a new treatment option and provide symptom relief for adults aged ≥2 years with mild to moderate AD. The findings were based on 2 separate analyses of crisaborole topical ointment, 2% in multicenter, double-blind, vehicle-controlled, phase 3 studies of identical design. The intent-to-treat (ITT) population studies of AD-301 and AD-302 consisted of 503 and 256 and 513 and 250 crisaborole and vehicle participants, respectively. The study drug was applied twice daily to all treatable areas of the body except the scalp. 

In the first study, the primary efficacy endpoint defined success in the Investigator’s Static Global Assessment (ISGA; clear or almost clear with a ≥2-grade improvement from baseline at day 29). Secondary endpoints included proportion of participants achieving ISGA clear or almost clear at day 29, and time to success in ISGA. Safety measurements included AEs. Efficacy analyses were permitted using the ITT population.

Paller et al found that crisaborole demonstrated statistically significant improvements compared with vehicle across all primary and secondary efficacy endpoints. Significantly more individuals achieved success in ISGA with crisaborole than vehicle at day 29 (P=.038 and P<.001 for AD-301 and AD-302, respectively). The proportion of participants achieving ISGA at day 29 with ointment vs vehicle in AD-301 were 32.8% and 25.4%, respectively; in AD-302, the findings were 31.4% vs 18.0, respectively. Additionally, significantly more participants treated with crisaborole achieved success in ISGA earlier than those treated with vehicle (P<.001). No treatment-related series AEs were reported among individuals treated with the ointment; the majority of AEs were mild in severity. 

In the second study, Herbert et al reported on the supportive efficacy endpoints evaluating crisaborole’s effect on pruritus and the signs of AD. Signs of AD (erythema, induration/papulation, exudation, excoriation, and lichenification) were measured weekly on days 1, 8, 15, 22, and 29. The severity of pruritus and signs of AD were evaluated on a 4-point scale (0=none to 3=severe). The percentage change in severity was defined as the change in severity of AD signs from baseline.

Crisaborole demonstrated greater improvement than vehicle in all clinical signs of AD. For example, at day 29, individuals treated with the ointment vs the vehicle showed improvement in erythema (59% vs 40%, respectively) and exudation (40% vs 30%, respectively). Participants in the crisaborole treatment arm compared with the vehicle arm experienced greater mean reductions in severity of AD from baseline to day 29. The crisaborole group also demonstrated greater improvement in pruritus across all study visits; improvement increased from 58% at day 8 to 63% at day 29. Median time to improvement in pruritus was achieved in 1.37 days and 1.70 days in the crisaborole and vehicle groups, respectively. 

winter conference
The recent Winter Clinical Dermatology Conference-Hawaii provided dermatologists with posters on the latest research and treatment options related to the field of dermatology. This section features those related to eczema and atopic dermatitis. 

Dupilumab Safe and Effective for AD

eczema

New data demonstrated that the novel biologic agent dupliumab significantly improved clinical outcomes compared with placebo for adults with moderate to severe atopic dermatitis (AD). Dupliumab is an investigational fully human monoclonal antibody that blocks interleukin (IL)-4 and IL-13 signaling.

For the study, Papp et al evaluated the efficacy of dupliumab 300 mg weekly using pooled data from 2 trials. The study enrolled 233 individuals in a 12- or 16-week randomized, double-blind, placebo-controlled, phase 2 study; individuals received weekly subcutaneous placebo (n=115) or dupilumab (n=118). Efficacy outcomes included absolute and percent change in Eczema Area and Severity Index (EASI) and SCORing of Atopic Dermatitis (SCORAD); participants who achieved EASI improvement ≥50 (ESAI 50) and ≥75 (EASI 75); and participants who achieved Investigator’s Global Assessment (IGA) score of ≤1 (clear or almost clear). Pooled efficacy and safety were assessed through week 12. 

At week 12, individuals in dupilumab treatment group showed significant improvement in all efficacy endpoints vs placebo. Dupilumab resulted in EASI change (mean ± standard deviation) of −21.1±12.0 from baseline values (29.3±12.4) compared with placebo (−6.9±14.0 from baseline of 31.9±13.7; P<.0001); mean percent change from baseline was greater with dupilumab vs placebo (−73.9% vs −22.9%, respectively; P<.0001). Significantly higher proportions of individuals in the dupilumab arm compared with placebo arm achieved EASI 50 and EASI 75 (85.6% and 61.0% vs 32.2% and 13.9%, respectively), and IGA ≤1 (36.4% vs 3.5%, respectively; P<.0001). Change in SCORAD from baseline was −37.0±18.8 and −10.9±19.6 for dupilumab and placebo, respectively; percent change was −56.6% vs −15.7%, respectively. 

The safety profile was acceptable and consistent with previous studies, according to the investigators. The pooled incidence of adverse events (AEs) through week 12 was similar for dupilumab (81.4%) and placebo (80.9%) treatment arms. The 3 most common AEs observed in the dupilumab group were nasopharyngitis (32.2%), headache (14.4%), and conjunctivitis (9.3%).

CeraVe Ointment Is Well Tolerated

A study from Zeichner et al evaluated the irritation, sensitization, and comeodogenic potential of CeraVe Healing Ointment in 3 study cohorts ranging in age from 18 to 79 years; skin reactions were assessed according to a 4-point scale (0=none to 4=severe).

Study cohort 1 included 108 individuals who were enrolled in an initial induction phase. The ointment was placed on the skin of the back under occlusive patch then removed after 24 hours on 3 separate days for 3 weeks. After a 2-week rest period, the ointment was applied to an untreated skin site on the back postpatch. The patch was removed 24 hours later and the skin was evaluated immediately and 72 hours after the patch was removed. Study cohort 2 included 29 participants who were evaluated over a 14-day period. The ointment or a control (water) were placed on the skin of the back under an occlusive patch, removed after 24 hours, and a fresh patch applied daily for 14 days. Study cohort 3 included 17 individuals with active case or a history of acne. CeraVe ointment, acetylated lanolin, or blank patch were applied to the skin of the back under an occlusive patch and removed after 48 to 72 hours, applications were repeated 3 times a week for 4 weeks. Additionally, follicular biopsies were performed and the presence of microcomedones were microscopically evaluated and rated on a 4-point scale (0=none to 3=severe).

Study cohort 1 showed that irritation scores were zero for both induction and challenge phases. There was no skin reactivity observed at any time. Study cohort 2 demonstrated that the total and mean cumulative irritation scores were zero for the ointment and control. Study cohort 3 had no skin irritation during the course of the study. Mean follicular scores for the ointment was 0.1 compared with 0.18 and 0.59 for the acetylated lanolin or blank patch, respectively.

Article continues on page 2

{{pagebreak}}

CeraVe Ointment Improves Skin Hydration         

Another study by Zeichner et al evaluated the effect of CeraVe Healing Ointment on stratum corneum hydration and skin barrier function in both normal and barrier-compromised skin in 2 study cohorts aged 18 to 55 years.

Study cohort 1 included 16 women who had the ointment applied to the volar forearm skin and compared with a nontreated control. Skin conductance and transepidermal water loss (TEWL) measurements were taken at 2, 4, 8, and 24 hours after application. Study cohort 2 included 39 participants with Fitzpatrick skin types I-III. A controlled shave procedure was performed to create a model of impaired skin barrier function similar to that of atopic skin. The ointment was applied twice daily for 3 days and participants were compared to shaved, untreated controls. Conductance readings were measured at baseline, the day after shaving but prior to treatment, and at 4 hours, and then daily on days 2 to 4 (18 hours after application). 

Participants in Study 1 showed significant differences in both skin surface hydration and TEWL values at 2, 4, and 8 hours posttreatment in the treated skin vs untreated controls. The mean conductance readings ranged from 429.6 to 493.5 compared with 248.5 to 283.5 in untreated controls. The mean TEWL rates ranged from 2.3 to 2.6 g/m2 hour compared with 3.4 to 3.5 g/m2 hour in the untreated controls. At 24 hours, the mean conductance readings were greater than untreated controls (320.1 vs 250.3, respectively), while TEWL values returned to baseline levels.

For study cohort 2, conductance readings dropped 28% to 29% immediately postshaving, consistent with the changes associated with barrier damage. Four hours posttreatment with the ointment, skin conductance levels had returned to pretrauma values and were significantly higher than untreated shaved control (P<.001). With continued applications of the ointment, skin conductance levels increased progressively and remained statistically higher vs the untreated controls (P<.001) for the study duration.

Crisaborole Potential New Treatment for AD

Crisaborole topical ointment, 2%—an investigational, nonsteroidal, topical, anti-inflammatory, phosphodiesterase 4 inhibitor—may offer a new treatment option and provide symptom relief for adults aged ≥2 years with mild to moderate AD. The findings were based on 2 separate analyses of crisaborole topical ointment, 2% in multicenter, double-blind, vehicle-controlled, phase 3 studies of identical design. The intent-to-treat (ITT) population studies of AD-301 and AD-302 consisted of 503 and 256 and 513 and 250 crisaborole and vehicle participants, respectively. The study drug was applied twice daily to all treatable areas of the body except the scalp. 

In the first study, the primary efficacy endpoint defined success in the Investigator’s Static Global Assessment (ISGA; clear or almost clear with a ≥2-grade improvement from baseline at day 29). Secondary endpoints included proportion of participants achieving ISGA clear or almost clear at day 29, and time to success in ISGA. Safety measurements included AEs. Efficacy analyses were permitted using the ITT population.

Paller et al found that crisaborole demonstrated statistically significant improvements compared with vehicle across all primary and secondary efficacy endpoints. Significantly more individuals achieved success in ISGA with crisaborole than vehicle at day 29 (P=.038 and P<.001 for AD-301 and AD-302, respectively). The proportion of participants achieving ISGA at day 29 with ointment vs vehicle in AD-301 were 32.8% and 25.4%, respectively; in AD-302, the findings were 31.4% vs 18.0, respectively. Additionally, significantly more participants treated with crisaborole achieved success in ISGA earlier than those treated with vehicle (P<.001). No treatment-related series AEs were reported among individuals treated with the ointment; the majority of AEs were mild in severity. 

In the second study, Herbert et al reported on the supportive efficacy endpoints evaluating crisaborole’s effect on pruritus and the signs of AD. Signs of AD (erythema, induration/papulation, exudation, excoriation, and lichenification) were measured weekly on days 1, 8, 15, 22, and 29. The severity of pruritus and signs of AD were evaluated on a 4-point scale (0=none to 3=severe). The percentage change in severity was defined as the change in severity of AD signs from baseline.

Crisaborole demonstrated greater improvement than vehicle in all clinical signs of AD. For example, at day 29, individuals treated with the ointment vs the vehicle showed improvement in erythema (59% vs 40%, respectively) and exudation (40% vs 30%, respectively). Participants in the crisaborole treatment arm compared with the vehicle arm experienced greater mean reductions in severity of AD from baseline to day 29. The crisaborole group also demonstrated greater improvement in pruritus across all study visits; improvement increased from 58% at day 8 to 63% at day 29. Median time to improvement in pruritus was achieved in 1.37 days and 1.70 days in the crisaborole and vehicle groups, respectively. 

winter conference
The recent Winter Clinical Dermatology Conference-Hawaii provided dermatologists with posters on the latest research and treatment options related to the field of dermatology. This section features those related to eczema and atopic dermatitis. 

Dupilumab Safe and Effective for AD

eczema

New data demonstrated that the novel biologic agent dupliumab significantly improved clinical outcomes compared with placebo for adults with moderate to severe atopic dermatitis (AD). Dupliumab is an investigational fully human monoclonal antibody that blocks interleukin (IL)-4 and IL-13 signaling.

For the study, Papp et al evaluated the efficacy of dupliumab 300 mg weekly using pooled data from 2 trials. The study enrolled 233 individuals in a 12- or 16-week randomized, double-blind, placebo-controlled, phase 2 study; individuals received weekly subcutaneous placebo (n=115) or dupilumab (n=118). Efficacy outcomes included absolute and percent change in Eczema Area and Severity Index (EASI) and SCORing of Atopic Dermatitis (SCORAD); participants who achieved EASI improvement ≥50 (ESAI 50) and ≥75 (EASI 75); and participants who achieved Investigator’s Global Assessment (IGA) score of ≤1 (clear or almost clear). Pooled efficacy and safety were assessed through week 12. 

At week 12, individuals in dupilumab treatment group showed significant improvement in all efficacy endpoints vs placebo. Dupilumab resulted in EASI change (mean ± standard deviation) of −21.1±12.0 from baseline values (29.3±12.4) compared with placebo (−6.9±14.0 from baseline of 31.9±13.7; P<.0001); mean percent change from baseline was greater with dupilumab vs placebo (−73.9% vs −22.9%, respectively; P<.0001). Significantly higher proportions of individuals in the dupilumab arm compared with placebo arm achieved EASI 50 and EASI 75 (85.6% and 61.0% vs 32.2% and 13.9%, respectively), and IGA ≤1 (36.4% vs 3.5%, respectively; P<.0001). Change in SCORAD from baseline was −37.0±18.8 and −10.9±19.6 for dupilumab and placebo, respectively; percent change was −56.6% vs −15.7%, respectively. 

The safety profile was acceptable and consistent with previous studies, according to the investigators. The pooled incidence of adverse events (AEs) through week 12 was similar for dupilumab (81.4%) and placebo (80.9%) treatment arms. The 3 most common AEs observed in the dupilumab group were nasopharyngitis (32.2%), headache (14.4%), and conjunctivitis (9.3%).

CeraVe Ointment Is Well Tolerated

A study from Zeichner et al evaluated the irritation, sensitization, and comeodogenic potential of CeraVe Healing Ointment in 3 study cohorts ranging in age from 18 to 79 years; skin reactions were assessed according to a 4-point scale (0=none to 4=severe).

Study cohort 1 included 108 individuals who were enrolled in an initial induction phase. The ointment was placed on the skin of the back under occlusive patch then removed after 24 hours on 3 separate days for 3 weeks. After a 2-week rest period, the ointment was applied to an untreated skin site on the back postpatch. The patch was removed 24 hours later and the skin was evaluated immediately and 72 hours after the patch was removed. Study cohort 2 included 29 participants who were evaluated over a 14-day period. The ointment or a control (water) were placed on the skin of the back under an occlusive patch, removed after 24 hours, and a fresh patch applied daily for 14 days. Study cohort 3 included 17 individuals with active case or a history of acne. CeraVe ointment, acetylated lanolin, or blank patch were applied to the skin of the back under an occlusive patch and removed after 48 to 72 hours, applications were repeated 3 times a week for 4 weeks. Additionally, follicular biopsies were performed and the presence of microcomedones were microscopically evaluated and rated on a 4-point scale (0=none to 3=severe).

Study cohort 1 showed that irritation scores were zero for both induction and challenge phases. There was no skin reactivity observed at any time. Study cohort 2 demonstrated that the total and mean cumulative irritation scores were zero for the ointment and control. Study cohort 3 had no skin irritation during the course of the study. Mean follicular scores for the ointment was 0.1 compared with 0.18 and 0.59 for the acetylated lanolin or blank patch, respectively.

Article continues on page 2

{{pagebreak}}

CeraVe Ointment Improves Skin Hydration         

Another study by Zeichner et al evaluated the effect of CeraVe Healing Ointment on stratum corneum hydration and skin barrier function in both normal and barrier-compromised skin in 2 study cohorts aged 18 to 55 years.

Study cohort 1 included 16 women who had the ointment applied to the volar forearm skin and compared with a nontreated control. Skin conductance and transepidermal water loss (TEWL) measurements were taken at 2, 4, 8, and 24 hours after application. Study cohort 2 included 39 participants with Fitzpatrick skin types I-III. A controlled shave procedure was performed to create a model of impaired skin barrier function similar to that of atopic skin. The ointment was applied twice daily for 3 days and participants were compared to shaved, untreated controls. Conductance readings were measured at baseline, the day after shaving but prior to treatment, and at 4 hours, and then daily on days 2 to 4 (18 hours after application). 

Participants in Study 1 showed significant differences in both skin surface hydration and TEWL values at 2, 4, and 8 hours posttreatment in the treated skin vs untreated controls. The mean conductance readings ranged from 429.6 to 493.5 compared with 248.5 to 283.5 in untreated controls. The mean TEWL rates ranged from 2.3 to 2.6 g/m2 hour compared with 3.4 to 3.5 g/m2 hour in the untreated controls. At 24 hours, the mean conductance readings were greater than untreated controls (320.1 vs 250.3, respectively), while TEWL values returned to baseline levels.

For study cohort 2, conductance readings dropped 28% to 29% immediately postshaving, consistent with the changes associated with barrier damage. Four hours posttreatment with the ointment, skin conductance levels had returned to pretrauma values and were significantly higher than untreated shaved control (P<.001). With continued applications of the ointment, skin conductance levels increased progressively and remained statistically higher vs the untreated controls (P<.001) for the study duration.

Crisaborole Potential New Treatment for AD

Crisaborole topical ointment, 2%—an investigational, nonsteroidal, topical, anti-inflammatory, phosphodiesterase 4 inhibitor—may offer a new treatment option and provide symptom relief for adults aged ≥2 years with mild to moderate AD. The findings were based on 2 separate analyses of crisaborole topical ointment, 2% in multicenter, double-blind, vehicle-controlled, phase 3 studies of identical design. The intent-to-treat (ITT) population studies of AD-301 and AD-302 consisted of 503 and 256 and 513 and 250 crisaborole and vehicle participants, respectively. The study drug was applied twice daily to all treatable areas of the body except the scalp. 

In the first study, the primary efficacy endpoint defined success in the Investigator’s Static Global Assessment (ISGA; clear or almost clear with a ≥2-grade improvement from baseline at day 29). Secondary endpoints included proportion of participants achieving ISGA clear or almost clear at day 29, and time to success in ISGA. Safety measurements included AEs. Efficacy analyses were permitted using the ITT population.

Paller et al found that crisaborole demonstrated statistically significant improvements compared with vehicle across all primary and secondary efficacy endpoints. Significantly more individuals achieved success in ISGA with crisaborole than vehicle at day 29 (P=.038 and P<.001 for AD-301 and AD-302, respectively). The proportion of participants achieving ISGA at day 29 with ointment vs vehicle in AD-301 were 32.8% and 25.4%, respectively; in AD-302, the findings were 31.4% vs 18.0, respectively. Additionally, significantly more participants treated with crisaborole achieved success in ISGA earlier than those treated with vehicle (P<.001). No treatment-related series AEs were reported among individuals treated with the ointment; the majority of AEs were mild in severity. 

In the second study, Herbert et al reported on the supportive efficacy endpoints evaluating crisaborole’s effect on pruritus and the signs of AD. Signs of AD (erythema, induration/papulation, exudation, excoriation, and lichenification) were measured weekly on days 1, 8, 15, 22, and 29. The severity of pruritus and signs of AD were evaluated on a 4-point scale (0=none to 3=severe). The percentage change in severity was defined as the change in severity of AD signs from baseline.

Crisaborole demonstrated greater improvement than vehicle in all clinical signs of AD. For example, at day 29, individuals treated with the ointment vs the vehicle showed improvement in erythema (59% vs 40%, respectively) and exudation (40% vs 30%, respectively). Participants in the crisaborole treatment arm compared with the vehicle arm experienced greater mean reductions in severity of AD from baseline to day 29. The crisaborole group also demonstrated greater improvement in pruritus across all study visits; improvement increased from 58% at day 8 to 63% at day 29. Median time to improvement in pruritus was achieved in 1.37 days and 1.70 days in the crisaborole and vehicle groups, respectively. 

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