Maintenance Effect of Clobex Shampoo on Participants With Moderate to Severe Scalp Psoriasis

Galderma

Status and phase: Completed; Phase 3

Conditions: Scalp Psoriasis

Treatments: Drug: Clobex® Shampoo; Drug: Clobex® Vehicle Shampoo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00400725

RD.03.SPR.29060

Details and patient eligibility

About

The objective of the study was to assess the maintenance effect on scalp psoriasis of Clobex® Shampoo 0.05% when used twice weekly.

Full description

Psoriasis was a chronic disease that was affecting skin, the scalp and joints. Scalp psoriasis was very common and was having an important impact on people's life.

Primary objective of scalp psoriasis treatments was to gain initial and rapid control of the disease process with a minimum of side-effects and improve patient quality of life.

Still, one of the unmet needs of scalp psoriasis therapies was the maintenance of a long-term remission. For corticosteroids in particular, one of the drawbacks was the disease recurrences after cessation of the treatment.

Therefore, the establishment of a modified corticosteroid dosing regimen that would allow remission with minimal side-effects was suitable.

The purpose of this study was to assess how long a patient successfully maintained in a good condition after use of Clobex® shampoo only twice a week.

Enrollment: 288 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects aged 18 years or older.
• Subjects with moderate to severe scalp psoriasis

Exclusion criteria

• Subjects who needed systemic treatment for their body psoriasis

• Subjects with a washout period for topical treatment(s) on the scalp less than:

  • Corticosteroids 2 weeks
  • All other anti-psoriasis medications 2 weeks

• Subjects with a washout period for systemic treatment(s) less than:

  • PUVA therapy 4 weeks
  • Biological therapies 12 weeks
  • Treatments other than biologicals with a possible efficacy on psoriasis 4 weeks
  • Treatment known to worsen psoriasis 2 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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288 participants in 3 patient groups, including a placebo group

Initial Phase:- Clobex® Shampoo

Experimental group

Description:

In initial open-label phase, participants were applied Clobex® shampoo (Clobetasol Propionate) 0.05 percent (%) weight by weight (W/W) topically to the scalp once daily (twice a week) for 4 weeks (weekly dose was not more than 50 grams \[50 Milliliter\]).

Treatment:

Drug: Clobex® Shampoo

Drug: Clobex® Shampoo

Maintenance Phase: Clobex® Shampoo

Experimental group

Description:

In maintenance double-blind phase, participants presented with a good efficacy (Global severity score \[GSS\] less than or equal to \[\<=\] 2) in initial phase were randomized to apply Clobetasol Propionate shampoo 0.05 % weight by weight (W/W) twice weekly up to 6 months (wherein weekly dose were not exceeded beyond 50 grams \[50 milliliter\]). In case of relapse (that is \[i.e.\], GSS greater than \[\>\] 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate shampoo 0.05%. After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).

Treatment:

Drug: Clobex® Shampoo

Drug: Clobex® Shampoo

Maintenance Phase: Clobex® Vehicle Shampoo

Placebo Comparator group

Description:

In maintenance double-blind phase, participants presented with a good efficacy (Global severity score \[GSS\] \<= 2) in initial phase were randomized to apply Clobex® vehicle shampoo twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse (i.e., GSS \[greater than\] \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate Shampoo 0.05 % (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).

Treatment:

Drug: Clobex® Vehicle Shampoo