Study 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

Inclusion Criteria
- 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.
Exclusion Criteria
- 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

Trial Dates

February 2019 - March 2019

Phase

Phase 4

Could I Receive a placebo

Products

Bepantol® Derma Spray (BAY207543)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Medcin Instituto da Pele	Sao 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.
Time 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).
Time 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).
Time 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).
Time Frame:
Up to 23 days
Number of adverse events by dermatological evaluation
Time Frame:
Up to 23 days
Number of adverse events by gynecological evaluation
Time Frame:
Up to 23 days
Severity of adverse events by dermatological evaluation
Time Frame:
Up to 23 days
Severity of adverse events by gynecological evaluation
Time 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

Additional Information

Click here to find results for studies related to Bayer products