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

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

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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)