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

NCT ID: NCT02749656

Last Updated: 2017-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Scalp Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.)

Group Type EXPERIMENTAL

0.25% Desoximetasone cream (Topoxy®)

Intervention Type DRUG

apply on the scalp psoriasis lesion twice a day

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.)

Group Type ACTIVE_COMPARATOR

0.25% Desoximetasone cream (Topicorte®)

Intervention Type DRUG

apply on the scalp psoriasis lesion twice a day

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.)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

apply on the scalp psoriasis lesion twice a day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

0.25% Desoximetasone cream (Topoxy®)

apply on the scalp psoriasis lesion twice a day

Intervention Type DRUG

0.25% Desoximetasone cream (Topicorte®)

apply on the scalp psoriasis lesion twice a day

Intervention Type DRUG

Placebo

apply on the scalp psoriasis lesion twice a day

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Topoxy® Topicorte® vehicle

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

SPS MEDICAL CO.,LTD.

UNKNOWN

Sponsor Role collaborator

Siriraj clinical research center

UNKNOWN

Sponsor Role collaborator

Siriraj Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pichanee Chaweekulrat

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Associated. Prof. Chanisada Wongpraparut, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Assist. Prof. Leena Chularojmontri, M.D.

Role: STUDY_CHAIR

Mahidol University

Assist. Prof. Narumol Silpa-archa, M.D.

Role: STUDY_CHAIR

Mahidol University

Pichanee Chaweekulrat, M.D.

Role: STUDY_CHAIR

Mahidol University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of dermatology Faculty of Medicine Siriraj Hospital

Bangkok, , Thailand

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Thailand

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Pichanee Chaweekulrat, M.D.

Role: CONTACT

+6686-886-5277

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Pichanee Chaweekulrat, MD

Role: primary

66868865277

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24301242 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 800971 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SPS01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Treatment of Psoriasis With Parathyroid Hormone
NCT00007306 COMPLETED PHASE1/PHASE2