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

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

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.

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 lasering depilation in the 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): 35
• 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: 16 years to 58 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 a dermatological procedure (laser depilation) in the inguinal region to remove hairs in the region

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
• 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

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 randomized to one side of the inguinal region and semisolid vaseline to the other side of the inguinal region after laser depilation. The side with BAY207543 is investigated.	Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray); Product is applied to one side of the inguinal region.; Other: Semisolid vaseline; Product is applied to one side of the inguinal region.
Active Comparator: Women_Inguinal side Vaseline; Adult women apply BAY207543 randomized to one side of the inguinal region and semisolid vaseline to the other side of the inguinal region after laser depilation. The side with vaseline is investigated.	Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray); Product is applied to one side of the inguinal region.; Other: Semisolid vaseline; Product is applied to one 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
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).	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).	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

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 11, 2019
• Primary Completion (Actual): March 11, 2019
• Study Completion (Actual): March 11, 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; Skin hydration; Sensorial perception; Dermal spray; Laser depilation
• Additional Relevant MeSH Terms: Dermatologic Agents; Emollients; Petrolatum
• Other Study ID Numbers: 20506

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