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

NCT02749656 | Unknown Phase 3 DMC

• 1 other identifier: SPS01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Scalp Psoriasis

Keywords

Scalp psoriasis; 0.25% Desoximetasone cream

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change of total sign score (TSS) after treatment

  2, 4 and 8 weeks

• Number of patients with clear or absent disease after treatment

  8 weeks

• Side effects after treatment

  2, 4 and 8 weeks

Study Arms (3)

0.25% Desoximetasone cream (Topoxy®)

EXPERIMENTAL

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®)

0.25% Desoximetasone cream (Topicorte®)

ACTIVE COMPARATOR

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®)

Placebo

PLACEBO COMPARATOR

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

Interventions

0.25% Desoximetasone cream (Topoxy®) DRUG

apply on the scalp psoriasis lesion twice a day

Also known as: Topoxy®

0.25% Desoximetasone cream (Topoxy®)

0.25% Desoximetasone cream (Topicorte®) DRUG

apply on the scalp psoriasis lesion twice a day

Also known as: Topicorte®

0.25% Desoximetasone cream (Topicorte®)

Placebo DRUG

apply on the scalp psoriasis lesion twice a day

Also known as: vehicle

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Diagnosed with scalp psoriasis by dermatologist
• 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
• Total severity of scalp psoriasis should be graded in mild to very severe according to Investigator's Global Assessment score (IGA)
• Clinical signs (redness, thickness, scaliness) should be scored as "Moderate" for at least 1 sign and "slight" on each of the other two signs
• All participants agree to participate in the study and already complete and sign consent form

You may not qualify if:

• 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
• Has skin infection or atrophic skin on the scalp
• Has history of allergic reaction or hypersensitivity to 0.25% Desoximetasone
• Female participants with pregnancy or in lactation period
• Participants who unable to come for follow-up visits at hospital
• Participants with other underlying disease e.g. diabetes mellitus, hypertension, thyroid disease
• Vulnerable subject e.g. illiterate person

Sponsors & Collaborators

• Siriraj Hospital: lead
• SPS MEDICAL CO.,LTD.: collaborator
• Siriraj clinical research center: collaborator

Study Sites (1)

Department of dermatology Faculty of Medicine Siriraj Hospital

Bangkok, 10900, Thailand

RECRUITING

Related Publications (2)

• 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.

  PMID: 24301242 BACKGROUND

• 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.

  PMID: 800971 BACKGROUND

MeSH Terms

Interventions

Desoximetasone

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dexamethasone; Steroids, Fluorinated

Study Officials

• Associated. Prof. Chanisada Wongpraparut, M.D.

  Mahidol University

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Central Study Contacts

Pichanee Chaweekulrat, M.D.

CONTACT

+6686-886-5277; pizzu43087@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 25, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 1, 2017

Record last verified: 2017-04

Locations

TH (1)