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Completed

NCT Number: NCT05863104

Assessment of Safety, Tolerability, Systemic Exposure and Efficacy of GPB Cream in Adolescents With Severe Primary Hyperhidrosis

The aim of this study is to evaluate the safety, tolerability and systemic exposure (in a subset of patients) of topical administration of 1% GPB in adolescents with severe primary axillary hyperhidrosis.

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Key information

Conditions

Primary Axillary Hyperhidrosis Hyperhidrosis Skin Diseases Skin and Connective Tissue Diseases Sweat Gland Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dr. Michael Sebastian

Mahlow, 15831, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medical diagnosis of severe primary axillary hyperhidrosis with a PRHS score of ≥5 with symptoms for at least 3 months before Screening
  • At least 50 mg of sweat production in each axilla measured gravimetrically over a period of 5 minutes at room temperature along with a humidity consistent with the normal climate in that area (patients have to acclimatize to that room for at least 30 minutes before the measurement)
  • Adolescents of both sexes aged 12 to 17 years (until study completion) with a body mass index percentile ≥10 and ≤90 (according to Kromeyer-Hauschild et al 2001)
  • Local tolerability assessment (skin reaction) score = 0

Exclusion criteria

  • Secondary hyperhidrosis, ie, hyperhidrosis that is secondary to other underlying diseases such as (but not limited to) hyperthyroidism, lymphoma, and malaria
  • Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage, ultrasonic surgery, microwave treatment (miraDry), or laser treatment
  • Botulinum toxin treatment for the treatment of axillary hyperhidrosis in the previous 4 months
  • Hypersensitivity to glycopyrrolate, or to any of the excipients of the investigational medicinal product (IMP)

Treatment and study plan

Glycopyrronium Bromide (GPB) Cream

Drug

Application of cream to each axilla

Primary outcomes

  1. Number of patients with Adverse Drug Reaction during treatment

    Time frame: Baseline to Day 57

  2. Number of patients with a local tolerability assessment (skin reaction score) >0 during treatment

    Time frame: Baseline to Day 57

  3. Αbsolute change in GP plasma concentration from Baseline to Day 15

    Time frame: Baseline to Day 15

Secondary outcomes

  1. Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 29

    Time frame: Baseline to Day 29

  2. Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 57

    Time frame: Baseline to Day 57

  3. Absolute change in logarithmic values of total sweat production assessed by GM from Day 29 to Day 57

    Time frame: Day 29 to Day 57

  4. Relative change in total sweat production assessed by GM from Baseline to Day 29 and Day 57

    Time frame: Baseline to Day 29 and Day 57

  5. Relative change in total sweat production assessed by GM from Day 29 to Day 57

    Time frame: Day 29 to Day 57

  6. Proportion of responders assessed by GM at Day 29 and Day 57

    Time frame: Day 29 and Day 57

  7. Absolute change in patient-rated hyperhidrosis severity (PRHS) score from Baseline to Day 29 and Day 57

    Time frame: Baseline to Day 29 and Day 57

    The patient-rated hyperhidrosis severity (PRHS) score will be assessed by asking the following question: "How did you perceive your underarm sweating in the past 24 hours? Please rate it on a scale from 0 (no sweating at all) to 10 (worst sweating that you ever had)"

  8. Absolute change in patient-rated hyperhidrosis severity (PRHS) score from Day 29 to Day 57

    Time frame: Day 29 to Day 57

    The patient-rated hyperhidrosis severity (PRHS) score will be assessed by asking the following question: "How did you perceive your underarm sweating in the past 24 hours? Please rate it on a scale from 0 (no sweating at all) to 10 (worst sweating that you ever had)"

  9. Absolute change in the Children's dermatology life quality index (CDLQI) score from Baseline to Day 29 and Day 57

    Time frame: Baseline to Day 29 and Day 57

    The Children's dermatology life quality index (CDLQI) is a simple 10-question questionnaire that assesses the burden of hyperhidrosis. It is validated for children aged 5-16 years. The answers to the questions are generally scored on a 4-point scale: 'very much' = 3, 'quite a lot' = 2, 'only a little' = 1, 'not at all' or question unanswered = 0.

    The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more impairment of the child's life is experienced.

  10. Absolute change in the Children's dermatology life quality index (CDLQI) score from Day 29 to Day 57

    Time frame: Day 29 to Day 57

    The Children's dermatology life quality index (CDLQI) is a simple 10-question questionnaire that assesses the burden of hyperhidrosis. It is validated for children aged 5-16 years. The answers to the questions are generally scored on a 4-point scale: 'very much' = 3, 'quite a lot' = 2, 'only a little' = 1, 'not at all' or question unanswered = 0.

    The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more impairment of the child's life is experienced.

  11. Absolute change in GP plasma concentration from Baseline to Day 8

    Time frame: Baseline to Day 8

  12. Absolute change in GP plasma concentration from Day 8 to Day 15

    Time frame: Day 8 to Day 15

  13. Frequency, severity, and relation of ADRs, SAEs, TEAEs, SUSARs, and discontinuations due to TEAEs

    Time frame: Screening to 14 Days after End of Treatment

  14. Local tolerability based on the skin reaction score

    Time frame: Day 1, Day 29, Day 57/End of Treatment and 14 Days after Day 57/End of Treatment

    Local tolerability at the application sites will be assessed and evaluated by the investigator using a skin reaction score: 'No evidence of irritation' = 0, 'Minimal erythema, barely perceptible' = 1, 'Definite erythema, readily visible; minimal edema or minimal popular response' = 2, 'Erythema and papules' = 3, 'Definite edema' = 4, 'Erythema, edema, and papules' = 5, 'Vesicular eruption' = 6, 'Strong reaction spreading beyond test site' = 7, 'Folliculitis' = 8.

  15. Neurological assessment of anticholinergic effects by a 4-point scale

    Time frame: 7 to 4 Days before Baseline, Day 15, Day 29, Day 43, Day 57/End of Treatment

    The occurrence of possible anticholinergic effects including dry mouth, dry eyes, blurred vision, red eyes, constipation, micturition disorder, drowsiness, and concentration difficulties is rated on a 4-point scale: 'severe intensity' = 3, 'moderate intensity' = 2, 'mild intensity' = 1, 'no evidence' = 0.

Sponsors and collaborators

Lead sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

Industry

Registry information

Official study title

An Open-label, Uncontrolled, Multicenter Study to Evaluate the Safety, Local Tolerability, Systemic Exposure, and Efficacy of 1% Glycopyrronium Bromide (GPB) Cream in Adolescents With Severe Primary Axillary Hyperhidrosis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 17, 2023
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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