Efficacy and Safety of 0.25% Desoximetasone Cream (Topoxy®) in the Treatment of Scalp Psoriasis

A Randomized Control Trial of Efficacy and Safety of 0.25% Desoximetasone Cream (Topoxy®) Compared With 0.25% Desoximetasone Cream (Topicorte®) in the Treatment of Scalp Psoriasis

The purpose of this study is to evaluate efficacy and safety of 0.25% Desoximetasone cream (Topoxy®) compare with 0.25% Desoximetasone cream (Topicorte®) in the treatment of scalp psoriasis.

Study Overview

• Status: Unknown
• Conditions: Scalp Psoriasis
• Intervention / Treatment: Drug: 0.25% Desoximetasone cream (Topoxy®); Drug: 0.25% Desoximetasone cream (Topicorte®); Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pichanee Chaweekulrat, M.D.; Phone Number: +6686-886-5277; Email: pizzu43087@gmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10900
    • Recruiting
    • Department of dermatology Faculty of Medicine Siriraj Hospital
    • Contact: Pichanee Chaweekulrat, MD; Phone Number: 66868865277; Email: pizzu43087@gmail.com
    • Principal Investigator: Chanisada Wongpraparut, MD
    • Sub-Investigator: Leena Chularojmontri, MD
    • Sub-Investigator: Narumol Silpa-archa, MD
    • Sub-Investigator: Pichanee Chaweekulrat, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. Diagnosed with scalp psoriasis by dermatologist
3. Has scalp psoriasis Involve ≥ 10% of total scalp area and also has clinical signs, or a previous diagnosis, of psoriasis on the trunk and/or limbs
4. Total severity of scalp psoriasis should be graded in mild to very severe according to Investigator's Global Assessment score (IGA)
5. Clinical signs (redness, thickness, scaliness) should be scored as "Moderate" for at least 1 sign and "slight" on each of the other two signs
6. All participants agree to participate in the study and already complete and sign consent form

Exclusion Criteria:

1. Treated with these medications before including in the study

   • Topical corticosteroid for scalp psoriasis (except emollients and shampoo) within 2 weeks
   • Very potent topical corticosteroids for psoriasis on other area or Narrow band Ultraviolet B (NB-UVB) within 2 weeks
   • Oral psoralen plus Ultraviolet A (PUVA) or oral medication (Methotrexate, Acitretin, Cyclosporine) within 4 weeks
   • Biologic agents or concomitant medication that could affect scalp psoriasis (Beta- blockers, Antimalarial drugs, Lithium ) within 6 months
2. Has skin infection or atrophic skin on the scalp
3. Has history of allergic reaction or hypersensitivity to 0.25% Desoximetasone
4. Female participants with pregnancy or in lactation period
5. Participants who unable to come for follow-up visits at hospital
6. Participants with other underlying disease e.g. diabetes mellitus, hypertension, thyroid disease
7. Vulnerable subject e.g. illiterate person

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.25% Desoximetasone cream (Topoxy®); 0.25% Desoximetasone cream (Topoxy®): apply on scalp psoriasis lesion twice a day for 8 weeks. (Tar shampoo will be given to all participants. The Shampoo should be applied on wet scalp every other day, then massage and allow shampoo to remain on the scalp for 5 minutes, after that rinse off by water.)	Drug: 0.25% Desoximetasone cream (Topoxy®); apply on the scalp psoriasis lesion twice a day; Other Names: Topoxy®
Active Comparator: 0.25% Desoximetasone cream (Topicorte®); 0.25% Desoximetasone cream (Topicorte®): apply on scalp psoriasis lesion twice a day for 8 weeks. (Tar shampoo will be given to all participants. The Shampoo should be applied on wet scalp every other day, then massage and allow shampoo to remain on the scalp for 5 minutes, after that rinse off by water.)	Drug: 0.25% Desoximetasone cream (Topicorte®); apply on the scalp psoriasis lesion twice a day; Other Names: Topicorte®
Placebo Comparator: Placebo; Placebo: apply on scalp psoriasis lesion twice a day for 8 weeks. (Tar shampoo will be given to all participants. The Shampoo should be applied on wet scalp every other day, then massage and allow shampoo to remain on the scalp for 5 minutes, after that rinse off by water.)	Drug: Placebo; apply on the scalp psoriasis lesion twice a day; Other Names: vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Investigator's Global Assessment score (IGA) after treatment	The Investigator's Global Assessment score (IGA) was recorded at the first visit and after treated 2,4 and 8 weeks with 0.25% Desoximetasone cream (Topoxy®), 0.25% Desoximetasone cream (Topicorte®) or placebo. The IGA score consisted of 6 points score (0 = absent disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease)	2, 4 and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of total sign score (TSS) after treatment	The Total sign score (TSS) was recorded at the first visit and after treated 2,4 and 8 weeks with 0.25% Desoximetasone cream (Topoxy®), 0.25% Desoximetasone cream (Topicorte®) or placebo. The TSS score was the sum of 5-point rating scores for erythema, induration and scaling (0 = no sign, 1 = slight signs, 2 = moderate signs, 3 = severe signs and 4 = very severe signs)	2, 4 and 8 weeks
Number of patients with clear or absent disease after treatment	Number of patients with clear or absent disease were recorded after treated 8 weeks with 0.25% Desoximetasone cream (Topoxy®), 0.25% Desoximetasone cream (Topicorte®) or placebo.	8 weeks
Side effects after treatment	Cutaneous side effects (e.g. skin discomfort, skin atrophy, telangiectasia) from 0.25% Desoximetasone cream were recorded after treated 2, 4 and 8 weeks. The side effects were scored as 0 = none, 1 = mild, 2 = moderate, 3 = severe for skin discomfort, skin atrophy and telangiectasia.	2, 4 and 8 weeks

Collaborators and Investigators

• Sponsor: Siriraj Hospital
• Collaborators: SPS MEDICAL CO.,LTD.; Siriraj clinical research center
• Investigators: Principal Investigator: Associated. Prof. Chanisada Wongpraparut, M.D., Mahidol University; Study Chair: Assist. Prof. Leena Chularojmontri, M.D., Mahidol University; Study Chair: Assist. Prof. Narumol Silpa-archa, M.D., Mahidol University; Study Chair: Pichanee Chaweekulrat, M.D., Mahidol University

Publications and helpful links

General Publications

• Kircik L, Lebwohl MG, Del Rosso JQ, Bagel J, Stein Gold L, Weiss JS. Clinical study results of desoximetasone spray, 0.25% in moderate to severe plaque psoriasis. J Drugs Dermatol. 2013 Dec;12(12):1404-10.
• Kuokkanen K. Comparison of 0.25% desoxymethasone ointment with 0.05% fluocinonide ointment in psoriasis. Curr Med Res Opin. 1976-1977;4(10):703-5. doi: 10.1185/03007997609112005.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: April 19, 2016
• First Submitted That Met QC Criteria: April 20, 2016
• First Posted (Estimate): April 25, 2016

Study Record Updates

• Last Update Posted (Actual): May 1, 2017
• Last Update Submitted That Met QC Criteria: April 28, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Scalp psoriasis; 0.25% Desoximetasone cream
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Desoximetasone
• Other Study ID Numbers: SPS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided