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

Primary Purpose

Scalp Psoriasis

Status
Unknown status
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
0.25% Desoximetasone cream (Topoxy®)
0.25% Desoximetasone cream (Topicorte®)
Placebo
Sponsored by
Siriraj Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scalp Psoriasis focused on measuring Scalp psoriasis, 0.25% Desoximetasone cream

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of dermatology Faculty of Medicine Siriraj HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

0.25% Desoximetasone cream (Topoxy®)

0.25% Desoximetasone cream (Topicorte®)

Placebo

Arm Description

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.)

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.)

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.)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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.
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.

Full Information

First Posted
April 19, 2016
Last Updated
April 28, 2017
Sponsor
Siriraj Hospital
Collaborators
SPS MEDICAL CO.,LTD., Siriraj clinical research center
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1. Study Identification

Unique Protocol Identification Number
NCT02749656
Brief Title
Efficacy and Safety of 0.25% Desoximetasone Cream (Topoxy®) in the Treatment of Scalp Psoriasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Siriraj Hospital
Collaborators
SPS MEDICAL CO.,LTD., Siriraj clinical research center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scalp Psoriasis
Keywords
Scalp psoriasis, 0.25% Desoximetasone cream

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
0.25% Desoximetasone cream (Topoxy®)
Arm Type
Experimental
Arm Description
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.)
Arm Title
0.25% Desoximetasone cream (Topicorte®)
Arm Type
Active Comparator
Arm Description
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.)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.)
Intervention Type
Drug
Intervention Name(s)
0.25% Desoximetasone cream (Topoxy®)
Other Intervention Name(s)
Topoxy®
Intervention Description
apply on the scalp psoriasis lesion twice a day
Intervention Type
Drug
Intervention Name(s)
0.25% Desoximetasone cream (Topicorte®)
Other Intervention Name(s)
Topicorte®
Intervention Description
apply on the scalp psoriasis lesion twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
vehicle
Intervention Description
apply on the scalp psoriasis lesion twice a day
Primary Outcome Measure Information:
Title
Change of Investigator's Global Assessment score (IGA) after treatment
Description
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)
Time Frame
2, 4 and 8 weeks
Secondary Outcome Measure Information:
Title
Change of total sign score (TSS) after treatment
Description
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)
Time Frame
2, 4 and 8 weeks
Title
Number of patients with clear or absent disease after treatment
Description
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.
Time Frame
8 weeks
Title
Side effects after treatment
Description
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.
Time Frame
2, 4 and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pichanee Chaweekulrat, M.D.
Phone
+6686-886-5277
Email
pizzu43087@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Associated. Prof. Chanisada Wongpraparut, M.D.
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Assist. Prof. Leena Chularojmontri, M.D.
Organizational Affiliation
Mahidol University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Assist. Prof. Narumol Silpa-archa, M.D.
Organizational Affiliation
Mahidol University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pichanee Chaweekulrat, M.D.
Organizational Affiliation
Mahidol University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of dermatology Faculty of Medicine Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10900
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pichanee Chaweekulrat, MD
Phone
66868865277
Email
pizzu43087@gmail.com
First Name & Middle Initial & Last Name & Degree
Chanisada Wongpraparut, MD
First Name & Middle Initial & Last Name & Degree
Leena Chularojmontri, MD
First Name & Middle Initial & Last Name & Degree
Narumol Silpa-archa, MD
First Name & Middle Initial & Last Name & Degree
Pichanee Chaweekulrat, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24301242
Citation
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.
Results Reference
background
PubMed Identifier
800971
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. doi: 10.1185/03007997609112005.
Results Reference
background

Learn more about this trial

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

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