check_circleStudy Completed

Skin recovery

Bayer Identifier:

20507

ClinicalTrials.gov Identifier:

NCT03853512

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 a peeling in the external genital area of women

Trial purpose

In this study, researchers want to learn more about the effect of dexpanthenol dermal spray on skin recovery after a dermatological procedure (peeling) in the intimate area of women.
After the peeling, participants will return within 3 weeks for 4 visits to the study center to investigate the skin conditions such redness, irritation, softness and possible side effects. In addition, study participants will 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 peeling in the genital area to improve the general appearance of the skin and bleaching of spots.

  • - 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
    - Hyperpigmentation 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
33
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 12 to 60 (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 19 items (each item is scored from 1-5) resulting in a score range of 19 to 95 (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
  • Number of adverse events by gynecological evaluation
    date_rangeTime Frame:
    Up to 23 days
  • Severity of adverse events by dermatological evaluation
    date_rangeTime Frame:
    Up to 23 days
  • Severity of adverse events by gynecological evaluation
    date_rangeTime Frame:
    Up to 23 days

Trial design

Safety Assessment, Instrumental and Perceived Efficacy 21 days of use at home – Bepantol Derma Spray® Dermal and Gynecological Acceptability Assessment.
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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