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

Phase 3

• Conditions: Scalp Psoriasis
• Interventions: Drug: 0.25% Desoximetasone cream (Topoxy®); Drug: 0.25% Desoximetasone cream (Topicorte®); Drug: Placebo

• Registration Number: NCT02749656
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-20
• Study First Posted: 2016-04-25
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-01
• Primary Completion: 2018-01
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.25% Desoximetasone cream (Topoxy®)	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®)	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	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.)

Primary Outcome Measures

Name	Time	Method
Change of Investigator's Global Assessment score (IGA) after treatment	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

Name	Time	Method
Side effects after treatment	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.
Change of total sign score (TSS) after treatment	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)
Number of patients with clear or absent disease after treatment	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.

Trial Locations

Locations (1)

Department of dermatology Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkok, Thailand