Evaluate the Efficacy and Safety of HL151 Versus Talion Tab. in Pruritus Cutaneus

Last updated: August 27, 2018
Sponsor: Hanlim Pharm. Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Rash

Hives (Urticaria)

Skin Wounds

Treatment

N/A

Clinical Study ID

NCT03317301
HL_HL151_302
  • Ages > 19
  • All Genders

Study Summary

a Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of HL151 versus Talion Tab. in Pruritus cutaneus.

  • Endpoint: VAS Score Change, Investigator's assessment of overall treatment

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Both gender, 19 years ≤ age

  2. Patients with pruritus due to the following diseases

① acute eczema, chronic eczema, monetary eczema, sebaceous deficiency eczema

② contact dermatitis, atopic dermatitis, seborrheic dermatitis, neurodermatitis

③ Acute prurigo (Strofus, Urticaria, lichen urticatus), subacute prurigo, chronicprurigo (nodular prurigo)

④ systemic skin pruritus, focal skin pruritus

  1. In visit 2, during the run-in period previous week the VAS score of day and night timewere 2 or more average points per day (maximum 4 points)

  2. Those who can ability to record subject diary

  3. Written consent voluntarily to participate in this clinical trial after understandingand detailed explanation about this clinical trial

Exclusion

Exclusion Criteria:

  1. Patients with pruritus due other medical causes (liver disease, heart failure, etc.)

  2. Among patients with skin disease, malignant tumors and patients with chronic urticariaskin disease

  3. Patients with systemic infection symptoms at the time of clinical trials

  4. Asthmatic patients requiring steroid treatment

  5. Patients with Spastic diseases such as epilepsy

Study Design

Total Participants: 189
Study Start date:
May 17, 2017
Estimated Completion Date:
January 30, 2018

Connect with a study center

  • Hanyang Univ. Guri Hospital

    Guri-si, Kyeonggi-do 471-701
    Korea, Republic of

    Site Not Available

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