In the Phase 4 study, 88.5% of adult patients achieved a target lesion Physician Global Assessment score of 0 (clear) or 1 (almost clear) and 2 or higher grade improvement from baseline at Week 12.

VTAMA (tapinarof) cream, 1% performed well in the treatment of psoriasis on the head and neck, according to its Phase 4, open-label trial.

In the two 12-week Phase 3 pivotal studies (PSOARING 1 and 2; N=1025), VTAMA cream demonstrated a Physician Global Assessment (PGA) success rate of 36% and 40% for adult patients with plaque psoriasis versus 6% for patients on vehicle at Week 12, respectively. 

The new study, DMVT-505-4002,  was a Phase 4, open-label multi-center study to investigate the efficacy and safety of VTAMA (tapinarof) cream, 1% for the treatment of adults with plaque psoriasis specifically in the head and neck region. The efficacy of VTAMA cream was assessed using a PGA evaluation of a target plaque psoriasis lesion in the head and neck region, Scalp n=18 (58.1%), Face n=11 (35.5%) and Neck n=2 (6.5%) identified at baseline. The trial enrolled 31 participants with mild, moderate, and severe head and neck plaque psoriasis (tPGA score ≥2) aged 18 years or older at 8 sites across the U.S. Patients received VTAMA cream once daily for 12 weeks with a follow up one week after study completion. Safety and tolerability were assessed by visit based on adverse events and local tolerability scores using the investigator-assessed Local Tolerability Scale (LTS) of the head and neck region and a Patient Satisfaction Questionnaire (PSQ) that was designed to assess patients’ satisfaction with VTAMA cream’s efficacy, formulation elegance, application ease, impact on daily life, and preference versus prior therapies.

The primary endpoint of the study was the proportion of adult patients who achieved a tPGA score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 12 (tPGA Success). The secondary endpoint of the study was the time to achieve tPGA Success. Additional exploratory endpoints of the study included ≥75% improvement in PASI, change from baseline in Peak Pruritus-Numeric Rating Scale (PP-NRS), ≥4point reduction in PP-NRS, and improvement in DLQI. Efficacy and PP-NRS assessments were specific to the head and neck region.

Phase 4 Results

Primary and Secondary Endpoints

• VTAMA cream reinforced strong efficacy for the treatment of head and neck plaque psoriasis (PsO), with 88.5% of adult patients (n=23/26) achieving a tPGA Success score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 12, the primary endpoint of the study.
• VTAMA cream showed a rapid onset of efficacy with tPGA Success achieved as early as Week 1 in some patients, with a median time of approximately 4 weeks, the secondary endpoint of the study.

Additional Endpoints

• At Week 12, 80.8% (n=21/26) of adult patients achieved complete clearance of the target lesion (tPGA=0) which was observed as early as Week 1 and with a median time of 8 weeks.
• At Week 12, 96.2% (n=25/26) of patients achieved PASI75 (≥75% reduction in PASI of the head and neck region), with achievement observed as early as Week 1.
• Onset of itch relief was apparent as early as Week 1 and increased over time with 70% (n=14/20) of patients achieving a clinically meaningful ≥4-point improvement in PP-NRS at Week 12.
• Substantial and clinically meaningful improvement in quality of life, as indicated by a 4-point improvement in DLQI, was achieved as early as Week 1 with further improvement out to Week 12.
• As indicated on the Patient Satisfaction Questionnaire, 93.3% (n=28/30) of subjects strongly agreed or agreed that VTAMA cream was not greasy, 86.7% (n=26/30) of subjects strongly agreed or agreed that VTAMA cream was easy to apply, and 96.7% (n=29/30) of subjects strongly agreed or agreed that VTAMA cream absorbs quickly.

Safety and Tolerability

• VTAMA cream was well tolerated with no new safety signals.
• The most common adverse reactions (incidence ≥ 5%) in subjects treated with VTAMA cream were folliculitis, contact dermatitis, headache, sinusitis, and seborrheic keratosis.

“Up to 80% of patients with plaque psoriasis experience scalp psoriasis, making it one of the most affected areas of the body. In this Phase 4 trial, a majority of the adult patients suffered from scalp psoriasis, making the outcomes from this trial significant, as they further reinforce the efficacy, safety, tolerability, and cosmetic elegance of VTAMA cream even when used in hair bearing areas such as the head and neck region,” says Philip M. Brown, MD, JD, Chief Medical Officer at Dermavant, in a news release. “The Phase 3 PSOARING studies and the Phase 4, open-label, intertriginous plaque psoriasis study combined with the Phase 4, open-label, head and neck data announced today, highlight the versatility of VTAMA cream, an efficacious, safe and well tolerated, non-steroidal treatment option for plaque psoriasis in all affected areas of the body.”

“Plaque psoriasis is a chronic condition with a significant negative impact on patients’ quality of life. The scalp region, in particular, is one of the most difficult areas to treat. Many currently available treatment options fail to offer sustained long-term relief due to lack of practical applicability to certain body areas and limitations on the duration of use,” adds G. Michael Lewitt, MD, FAAD, a dermatologist in Illinois Dermatology Institute. “The impressive levels of efficacy achieved by VTAMA cream in the open-label trial, where 80% of adult patients achieved complete clearance of the target lesion, is highly encouraging for both patients with plaque psoriasis and their healthcare providers. Importantly, 58% of patients enrolled in the trial had a target plaque psoriasis lesion in the scalp region, and as assessed by both the investigators and the patients in the trial, VTAMA cream demonstrated favorable tolerability even when applied in hair bearing affected areas; making it a versatile and cosmetically elegant treatment option for plaque psoriasis that can be used anywhere on the affected body areas, including the most sensitive areas as well the scalp, head, and neck areas.”