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Trial record 20 of 32 for:    PANTHENOL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03853525
Recruitment Status : Completed
First Posted : February 25, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Skin Recovery Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray) Other: Semisolid vaseline Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 11, 2019
Actual Primary Completion Date : March 11, 2019
Actual Study Completion Date : March 11, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Petrolatum

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.




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


Secondary Outcome Measures :
  1. Skin properties of the participants [ Time Frame: Up to 23 days ]
    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).

  2. Treatment satisfaction [ Time Frame: Up to 23 days ]
    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).

  3. Product evaluation [ Time Frame: Up to 23 days ]
    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).

  4. Number of adverse events by dermatological evaluation [ Time Frame: Up to 23 days ]
  5. Severity of adverse events by dermatological evaluation [ Time Frame: Up to 23 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03853525


Locations
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Brazil
Medcin Instituto da Pele
Sao Paulo, Brazil, 06023-070
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03853525     History of Changes
Other Study ID Numbers: 20506
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Dermal spray
Laser depilation
Skin hydration
Consumer satisfaction
Sensorial perception
Additional relevant MeSH terms:
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Petrolatum
Emollients
Dermatologic Agents