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

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Bayer

Status and phase

Completed
Phase 4

Conditions

Skin Recovery

Treatments

Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray)
Other: Semisolid vaseline

Study type

Interventional

Funder types

Industry

Identifiers

NCT03853512
20507

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

33 participants in 2 patient groups

Women_Inguinal side BAY207543
Experimental group
Description:
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.
Treatment:
Other: Semisolid vaseline
Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray)
Women_Inguinal side Vaseline
Active Comparator group
Description:
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.
Treatment:
Other: Semisolid vaseline
Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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