Scalp PsoriasisPhase 3NCT02749656
Efficacy and Safety of 0.25% Desoximetasone Cream (Topoxy®) in the Treatment of Scalp Psoriasis
A Phase 3 study testing 0.25% Desoximetasone cream (Topoxy®) and 0.25% Desoximetasone cream (Topicorte®) in people with Scalp Psoriasis, run by Siriraj Hospital at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scalp Psoriasis
- What is being tested?
- 0.25% Desoximetasone cream (Topoxy®) and 0.25% Desoximetasone cream (Topicorte®)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2016to Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Department of dermatology Faculty of Medicine Siriraj Hospital
Bangkok, 10900
Pichanee Chaweekulrat, MD, 66868865277, pizzu43087@gmail.com
Chanisada Wongpraparut, MD
About this study
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
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
- Being tested
- 0.25% Desoximetasone cream (Topoxy®), 0.25% Desoximetasone cream (Topicorte®), Placebo
- Keywords
- Scalp psoriasis, 0.25% Desoximetasone cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.25% Desoximetasone cream (Topoxy®)Drug
Also called Topoxy®
apply on the scalp psoriasis lesion twice a day
0.25% Desoximetasone cream (Topicorte®)Drug
Also called Topicorte®
apply on the scalp psoriasis lesion twice a day
PlaceboDrug
Also called vehicle
apply on the scalp psoriasis lesion twice a day
| Study group | Role | What they receive |
|---|---|---|
| 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.) Receives: 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.) Receives: 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.) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2, 4 and 8 weeks
Secondary outcomes (3)
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)
Measured: 2, 4 and 8 weeks
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.
Measured: 8 weeks
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.
Measured: 2, 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study start1 Jan 2016
- Primary completionJan 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Scalp PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SPS MEDICAL CO.,LTD., Siriraj clinical research center
- Responsible party
- Principal investigator, Pichanee Chaweekulrat, Siriraj Hospital
- Investigators
- Associated. Prof. Chanisada Wongpraparut, M.D., Principal investigator, Mahidol UniversityAssist. Prof. Leena Chularojmontri, M.D., Study chair, Mahidol UniversityAssist. Prof. Narumol Silpa-archa, M.D., Study chair, Mahidol UniversityPichanee Chaweekulrat, M.D., Study chair, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749656
- Sponsor's protocol ID
- SPS01
- Status last verified
- Apr 2017
- First submitted
- 19 Apr 2016
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 24301242Kuokkanen 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.
PubMed 800971
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02749656
- Acronym / sponsor ID
- SPS01
- Conditions
- Scalp Psoriasis
- Keywords
- Scalp psoriasis, 0.25% Desoximetasone cream
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Collaborators
- SPS MEDICAL CO.,LTD., Siriraj clinical research center
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.25% Desoximetasone cream (Topoxy®) | Experimental | Drug: 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.) |
| 0.25% Desoximetasone cream (Topicorte®) | Active comparator | Drug: 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.) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo: 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.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- Treated with these medications before including in the study
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.25% Desoximetasone cream (Topoxy®)Also: Topoxy®apply on the scalp psoriasis lesion twice a day | Drug | 0.25% Desoximetasone cream (Topoxy®) |
| 0.25% Desoximetasone cream (Topicorte®)Also: Topicorte®apply on the scalp psoriasis lesion twice a day | Drug | 0.25% Desoximetasone cream (Topicorte®) |
| PlaceboAlso: vehicleapply on the scalp psoriasis lesion twice a day | Drug | Placebo |
Primary outcome
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)
3 secondary outcomes
Change of total sign score (TSS) after treatment
Time frame: 2, 4 and 8 weeks
Number of patients with clear or absent disease after treatment
Time frame: 8 weeks
Side effects after treatment
Time frame: 2, 4 and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Background: PubMed 24301242Kircik 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.
- Background: PubMed 800971Kuokkanen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Associated. Prof. Chanisada Wongpraparut, M.D. principal investigator
Mahidol University
Assist. Prof. Leena Chularojmontri, M.D. study chair
Mahidol University
Assist. Prof. Narumol Silpa-archa, M.D. study chair
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.25% Desoximetasone cream (Topoxy®) and 0.25% Desoximetasone cream (Topicorte®) in people with Scalp Psoriasis, run by Siriraj Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pichanee Chaweekulrat, M.D. (+6686-886-5277, pizzu43087@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Investigator's Global Assessment score (IGA) after treatment (time frame: 2, 4 and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02749656, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2017.