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

Skin Recovery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03853525
• Other study ID #: 20506
• Status: Completed
• Phase: Phase 4
• Start date: February 11, 2019
• Est. completion date: March 11, 2019

Study information

• Verified date: March 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 11, 2019
• Est. primary completion date: March 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Recovery

Intervention

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.

Locations

Country	Name	City	State
Brazil	Medcin Instituto da Pele	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of adverse events by dermatological evaluation		Up to 23 days
Secondary	Severity of adverse events by dermatological evaluation		Up to 23 days

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