check_circleStudy Completed

Skin recovery

Bayer Identifier:

20506

ClinicalTrials.gov Identifier:

NCT03853525

EudraCT Number:

Not Available

EU CT Number:

Not Available
A study to gain information how well dexpanthenol dermal spray helps the skin to recover after laser hair removal in the groin and intimate area

Trial purpose

In this study, researchers want to learn more about the effect of dexpanthenol dermal spray on skin recovery after a dermatological procedure for hair removal (laser depilation) in the groin and intimate area in adult women.
After the hair removal procedure, participants will return within 3 weeks for 3 visits to the study center to investigate the skin condition such as redness, irritation, softness of skin and possible side effects. Study participants will also be asked about their general acceptance of dexpanthenol dermal spray.

Key Participants Requirements

Sex

Female

Age

18 - 60 Years
  • - Phototypes I and II according to the Fitzpatrick scale
    - Participants willing to have a dermatological procedure (laser depilation) in the inguinal region to remove hairs in the region

  • - Pathologies and/or skin injuries, such as psoriasis, sensitive skin, skin cancer, atopic dermatitis or other medical criteria to be considered at the time of evaluation
    - Hyperpigmentations in the test area that interfere with the evaluation of possible reactions (vascular malformations, scars, increase of pilosity and large amount of nevi)
    - Pathologies and/or active skin injuries (local and/or disseminated) in the evaluation area

Trial summary

Enrollment Goal
35
Trial Dates
February 2019 - March 2019
Phase
Phase 4
Could I Receive a placebo
No
Products
Bepantol® Derma Spray (BAY207543)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Medcin Instituto da PeleSao Paulo, 06023-070, Brazil

Primary Outcome

  • Transepidermal water loss by TEWL probe
    The transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300.
    date_rangeTime Frame:
    Up to 23 days

Secondary Outcome

  • Skin properties of the participants
    Investigators assess various skin properties of the participants with a questionnaire (each scored from 1 to 5), resulting in an overall efficacy score from 9 to 45 (a higher score represents higher efficacy).
    date_rangeTime Frame:
    Up to 23 days
  • Treatment satisfaction
    Participants assess their treatment satisfaction with a questionnaire consisting of 13 items (each item is scored from 1-5) resulting in a score range of 13 to 65 (a higher score represents better treatment satisfaction).
    date_rangeTime Frame:
    Up to 23 days
  • Product evaluation
    Participants assess their sensorial perception of different product attributes (e.g. smell, absorption) with a questionnaire consisting of 6 items (each item is scored from 1-5) resulting in a score range from 6 to 30 (a higher score represents higher product satisfaction).
    date_rangeTime Frame:
    Up to 23 days
  • Number of adverse events by dermatological evaluation
    date_rangeTime Frame:
    Up to 23 days
  • Severity of adverse events by dermatological evaluation
    date_rangeTime Frame:
    Up to 23 days

Trial design

Safety and Efficacy Evaluation of the use of Bepantol® Derma Spray after laser depilation in the inguinal region in adult women - 21 Days Use at Home
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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