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

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ClinicalTrials.gov Identifier: NCT02749656
Recruitment Status : Unknown
Verified April 2017 by Pichanee Chaweekulrat, Siriraj Hospital.
Recruitment status was:  Recruiting
First Posted : April 25, 2016
Last Update Posted : May 1, 2017
Sponsor:
Collaborators:
SPS MEDICAL CO.,LTD.
Siriraj clinical research center
Information provided by (Responsible Party):
Pichanee Chaweekulrat, Siriraj Hospital

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.

Condition or disease Intervention/treatment Phase
Scalp Psoriasis Drug: 0.25% Desoximetasone cream (Topoxy®) Drug: 0.25% Desoximetasone cream (Topicorte®) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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 Name: 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 Name: 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 Name: vehicle




Primary Outcome Measures :
  1. Change of Investigator's Global Assessment score (IGA) after treatment [ Time Frame: 2, 4 and 8 weeks ]
    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 :
  1. Change of total sign score (TSS) after treatment [ Time Frame: 2, 4 and 8 weeks ]
    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. Number of patients with clear or absent disease after treatment [ Time Frame: 8 weeks ]
    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.

  3. Side effects after treatment [ Time Frame: 2, 4 and 8 weeks ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749656


Contacts
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Contact: Pichanee Chaweekulrat, M.D. +6686-886-5277 pizzu43087@gmail.com

Locations
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Thailand
Department of dermatology Faculty of Medicine Siriraj Hospital Recruiting
Bangkok, Thailand, 10900
Contact: Pichanee Chaweekulrat, MD    66868865277    pizzu43087@gmail.com   
Principal Investigator: Chanisada Wongpraparut, MD         
Sub-Investigator: Leena Chularojmontri, MD         
Sub-Investigator: Narumol Silpa-archa, MD         
Sub-Investigator: Pichanee Chaweekulrat, MD         
Sponsors and Collaborators
Siriraj Hospital
SPS MEDICAL CO.,LTD.
Siriraj clinical research center
Investigators
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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:
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Responsible Party: Pichanee Chaweekulrat, M.D., Siriraj Hospital
ClinicalTrials.gov Identifier: NCT02749656     History of Changes
Other Study ID Numbers: SPS01
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Pichanee Chaweekulrat, Siriraj Hospital:
Scalp psoriasis
0.25% Desoximetasone cream

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Desoximetasone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs