1. Evaluation of safety and efficacy of
Fairness Cream
ANAND KUMAR B.H.
ABSTRACT
People use fairness creams to improve their complexion, irrespective of whether they have dark or
fair complexion. Fairness creams block sun rays and prevent secretion of melanin, which gives
dark color to skin. The purpose of this open, prospective, non-comparative, phase III clinical study
was to evaluate the safety and efficacy of Fairness Cream as a result of repeated application for
4 weeks. One hundred subjects were included in this study. They were advised to apply Fairness
Cream twice daily for a period of 30 days. All the patients were followed-up at weekly intervals
for a period of 4 weeks. Response to Fairness Cream was evaluated on a 5-point visual analogue
scale. All subjects completed the study and significant reduction in dark complexion, increase in
skin softness, and skin glowing effect was seen at the end of the study. There were no adverse
effects reported during the study and compliance to the use of formulation was excellent.
Key words: Fairness Cream, complexion, skin glowing effect, nourishing effect, moisturizing effect.
INTRODUCTION: radiation. It acts as a photosensitizer, nourishes the skin, and makes it soft.
The craze for modern fairness and increases sun sensitivity and skin It penetrates deep into the skin. It
creams has emerged in the last fifty ageing. has nourishing and moisturizing
years. Fairness is considered equal Skin color is determined by the activities. It contains extracts of Aloe
to attractiveness. People use fairness absolute amount and concentration vera, Juglans regia, Rosa centifolia,
creams to improve their complexion, of melanin in the skin. and Citrus reticulata, as its main
irrespective of whether they have constituents.
dark or fair complexion. With time and under cumulative
A clinical trial was planned to test
UV exposure, an excess of melanin is
Melanin is the primary determinant the safety and efficacy of Fairness
produced within the skin. This
of human skin color. Melanin is Cream as a result of repeated
overproduction leads to an irregular
produced in specialized skin cells application for 4 weeks.
distribution of melanin. Skin
called melanocytes that are located pigmentation becomes uneven and Aim of the study:
in the epidermis. 1 The increased brown spots form. This phenomenon The purpose of this study was to
production of melanin in human skin is accentuated by the accumulation evaluate the safety and efficacy of
is called melanogenesis. 2 It is of dead cells on the skin’s surface. Fairness Cream as a result of repeated
stimulated by DNA damage caused Skin surface becomes rough, irregular, application for 4 weeks.
by UVB-radiation, and leads to a and no longer reflects natural light.
delayed development of tan. 3 In Skin looks dull, as if veiled. MATERIALS AND METHODS:
humans, the two types of melanin4 This study was an open,
present in the skin (eumelanin and Fairness creams are expected to
prospective, non-comparative, phase
pheomelanin) are responsible for block sun rays and prevent secretion
III clinical trial.
different skin tones (which is induced of melanin, which gives dark color to
by ultraviolet radiation), and are the the skin. So in effect, fairness creams Inclusion criteria:
constituents of freckles. Eumelanin is reduce tan and prevent the skin from A hundred subjects (72 female
a black or brown pigment, and is getting darker by preventing melanin and 28 male), aged between 18 to 45
mainly concerned with the protection secretion. years, who were willing to give
of the skin by absorbing incoming Most of the fairness creams informed written consent were
UV radiation. contain a bleaching agent called included in the study.
Pheomelanin is a reddish pigment “hydroquinol”. Other chemical Exclusion criteria:
and a very weak absorptive of UV substances are also present in these
Individuals with acne, skin
creams. Long-term use of these creams
infection over face, individuals on
Dr. B.H. Anand Kumar may cause side effects.
Senior Skin Specialist
treatment with ultraviolet light,
Bowring and Lady Curzon Hospital Fairness Cream (manufactured by widespread active dermatitis or
Bangalore, India. The Himalaya Drug Company, dermatitis on test area, immuno-
Specially Contributed to "The Antiseptic" Bangalore, India) is a polyherbal compromised individuals, and those
Vol. 106 No. 5 & P : 239 - 241 formulation that improves complexion, who refused to give informed written
May 2009 THE ANTISEPTIC 239

2. consent were excluded from the study. discomfort during the study or in skin softness, and skin glowing
Pregnant and lactating women were sustained serious clinical events effect was seen at the end of the
also excluded from the study. requiring specific treatment. For study.
patients withdrawing from the study,
Study procedure: None of them was withdrawn from
efforts were made to ascertain the
All the volunteers who were reason for dropout. Non-compliance the therapy either for adverse events
willing to participate in the trial were (defined as failure to use less than or other reasons.
screened for inclusion in the study. 80% of the medication) was not Results indicated that Fairness
They were advised to clean the neck regarded as treatment failure, and Cream improves complexion,
and face area thoroughly and then reasons for non-compliance were nourishes and makes the skin soft,
apply Fairness Cream twice daily for noted. and ensures ease of application and
a period of 4 weeks. faster absorption, which provide
Statistical analysis:
Follow-up and assessment: Statistical analysis was carried out better nourishment to the skin. It also
using Fisher’s exact test to find out effectively lightens overall complexion
All the patients were followed-up
at weekly intervals for a period of 4 the level of significance. (Table 1).
weeks, and the symptom score The minimum level of significance There were no adverse effects
evaluation was done during each was fixed at p<0.05. Statistical reported during the study and
follow-up visit. Response to Fairness analysis was carried out using Graph compliance to the use of formulation
Cream was evaluated on a 5-point Pad Prism software Version 4.01. was excellent (Table 2).
visual analogue scale (0-Nil, 1-Mild,
RESULTS: DISCUSSION:
2- Moderate, 3- Good, and 4–
Excellent). A total of 100 subjects (72 female Melanin is the primary determinant
Primary and secondary and 28 male) were enrolled for the of human skin color. Ultraviolet
endpoints: study. All subjects completed the radiation causes damage to the nuclei
study as planned. Significant of skin cells, leading to production of
The predefined primary efficacy reduction in dark complexion, increase melanin.
endpoint was a decrease in the
symptom score for dark complexion.
The predefined secondary safety
endpoints were acute and chronic Table 1: Effect of Fairness Cream at the end of the study
safety, as assessed by the incidence No. of subjects
of adverse events and patient
compliance to therapy. Effect Reduction in Increased Skin
dark skin glowing
Adverse events:
complexion softness effect
All the adverse events, either
reported or observed by the patients, Excellent 33 21 25
were recorded with information about Responders 79* 80* 72*
severity, date of onset, duration, and Good 46 59 47
action taken regarding the study drug. Moderate 13 16 20
Relation of adverse events to study
medication was predefined as Non- 21 20 28
Mild 6 4 4
“Unrelated” (a reaction that does not responders
follow a reasonable temporal Nil 2 0 4
sequence from the administration of
the drug), “Possible” (follows a *p<0.05
known response pattern to the
suspected drug, but could have been
produced by the patient’s clinical
state or other modes of therapy
administered to the patient), and
“Probable” (follows a known Table 2: Type of adverse effect
response pattern to the suspected
drug that could not be reasonably Parameters On 1st application At the end of the study
explained by the known
characteristics of the patient’s clinical Erythema Nil Nil
state).
Edema Nil Nil
Patients were allowed to
voluntarily withdraw from the study, Pruritus and Urticaria Nil Nil
if they had experienced serious
240 THE ANTISEPTIC May 2009

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