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

Safety Assessment, Instrumental and Perceived Efficacy 21 Days of Use at Home - Bepantol Derma Spray® Dermal and Gynecological Acceptability Assessment.

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.

Study Overview

• Status: Completed
• Conditions: Skin Recovery
• Intervention / Treatment: Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray); Other: Semisolid vaseline

Detailed Description

The primary objective is to evaluate the efficacy of the test product to aid skin recovery after peeling in the female intima and inguinal region.

Secondary objectives comprise clinical efficacy with respect to skin hydration, softness, vitality, appearance etc. and skin recovery, consumer judgement of product performance and acceptability, and safety.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 06023-070
    • Medcin Instituto Da Pele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Women_Inguinal side BAY207543; Adult women apply BAY207543 to one side of the inguinal region, and semisolid vaseline to the the opposite side after skin peeling. The area with BAY207543 will be investigated.	Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray); Product is applied to one side of the inguinal region.; Other: Semisolid vaseline; Product is applied to the other side of the inguinal region.
Active Comparator: Women_Inguinal side Vaseline; Adult women apply BAY207543 to one side of the inguinal region, and semisolid vaseline to the the opposite side after skin peeling. The area with the vaseline will be investigated.	Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray); Product is applied to one side of the inguinal region.; Other: Semisolid vaseline; Product is applied to the other side of the inguinal region.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events by dermatological evaluation		Up to 23 days
Severity of adverse events by dermatological evaluation		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).	Up to 23 days
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).	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).	Up to 23 days
Number of adverse events by gynecological evaluation		Up to 23 days
Severity of adverse events by gynecological evaluation		Up to 23 days

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2019
• Primary Completion (Actual): March 13, 2019
• Study Completion (Actual): March 13, 2019

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Consumer satisfaction; Peeling; Skin hydration; Sensorial perception; Dermal spray
• Additional Relevant MeSH Terms: Dermatologic Agents; Emollients; Petrolatum
• Other Study ID Numbers: 20507

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

IPD Plan Description

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No