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

Scalp Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02749656
• Other study ID #: SPS01
• Status: Recruiting
• Phase: Phase 3
• First received: April 19, 2016
• Last updated: April 28, 2017
• Start date: January 1, 2016
• Est. completion date: December 2018

Study information

• Verified date: April 2017
• Source: Siriraj Hospital
• Contact: Pichanee Chaweekulrat, M.D.
• Phone: +6686-886-5277
• Email: pizzu43087[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: December 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Scalp Psoriasis

Intervention

Drug:
• 0.25% Desoximetasone cream (Topoxy®)
apply on the scalp psoriasis lesion twice a day
• 0.25% Desoximetasone cream (Topicorte®)
apply on the scalp psoriasis lesion twice a day
• Placebo
apply on the scalp psoriasis lesion twice a day

Locations

Country	Name	City	State
Thailand	Department of dermatology Faculty of Medicine Siriraj Hospital	Bangkok

Sponsors (3)

Lead Sponsor	Collaborator
Siriraj Hospital	Siriraj clinical research center, SPS MEDICAL CO.,LTD.

Country where clinical trial is conducted

Thailand, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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